Title of Invention	A BLISTER PACKAGE
Abstract	A blister package (10) and method of removing a dosage form (1) from a blister package (10) are disclosed. In one embodiment, the blister package (10) includes a unitary blister sheet (12) and a unitary sheet of lidding material (14). The lidding sheet (14) is peelably sealed to the blister sheet (12), and includes unsealed areas (28) for facilitating the peeling of the lidding material (14) from the blister sheet (12). The unsealed areas (28) are preferably only accessible upon a bending of the blister package (10).

Title of Invention

A BLISTER PACKAGE

Abstract

A blister package (10) and method of removing a dosage form (1) from a blister package (10) are disclosed. In one embodiment, the blister package (10) includes a unitary blister sheet (12) and a unitary sheet of lidding material (14). The lidding sheet (14) is peelably sealed to the blister sheet (12), and includes unsealed areas (28) for facilitating the peeling of the lidding material (14) from the blister sheet (12). The unsealed areas (28) are preferably only accessible upon a bending of the blister package (10).

Full Text	BEND AND PEEL TABLET PACKAGE CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of the filing date of United States Provisional Patent Application No. 60/644,393 filed January 14, 2005, the disclosure of which is hereby incorporated herein by reference BACKGROUND OF THE INVENTION [0002] Many people, as part of their daily routine, take various types of medication. Some may take several different types of pharmaceutical dosage forms in a given period. These pharmaceutical dosage forms may include pills, capsules, tablets, liquids and the like. As with many industries for which a tangible product is offered for sale, packaging is an issue. Often times, the manner in which a product is offered is a deciding factor in whether or not a purchase is made. This situation is no different in the pharmaceutical field. But other concerns may also drive the style of packaging in the pharmaceutical industry. [0003] One packaging concern is the nature of the dosage form. Some tablets, for example, are frangible, friable or breakable (used synonymously) . Such dosage forms may be easily damaged both during transport of the package and by a user upon opening. The disclosures of commonly assigned U.S. Pat. Nos. 5,178,878 and 5,223,264, which are hereby incorporated by reference herein, describe relatively soft tablets which are susceptible to this type of damage. Tablets which fall into this category tend to have a low hardness and high friability, and may include very soft tablets with a hardness below about 15 Newtons. [0004] Standard dosage forms are typically packaged in blister packages, which are comprised of multi-layered sheets of material having pockets, blisters or wells for containing the dosage forms. One type of conventional blister packages includes packages having a foil layer through which a user of 2 the package must push the tablet, thereby breaking the foil. An example of such a conventional blister package is shown in U.S. Pat. No. 4,158,411 to Hall et al., the disclosure of which is hereby incorporated by reference herein. While this type of package is sufficient for packaging standard dosage forms, packaging of frangible dosage forms in such a package would cause damage to the frangible dosage form when attempting to push it through the foil layer. These types of packages are also generally not child proof. [0005] Another concern with the packaging of pharmaceutical dosage forms, whether they are frangible dosage forms or not, relates to safety. Child proof or child resistant packaging is often very desirable for the packaging of dosage forms. Clearly, a big concern with having medication in the home is the possibility of a child gaining access to it. On the other hand, child-proof packages may also be quite difficult to open by the elderly, handicapped or people in great pain. There needs to be a balance struck, therefore, between safety and ease of use. Packages that are more difficult for children to open than, for example, the elderly are therefore highly desirable. In addition, not all child proof packaging is the same. Packaging is often rated based on the number of children who can gain access to the drug in five minutes. One example of testing procedure standards for achieving these ratings is set forth in 16 C.P.R., and in particular § 1700.00 through 1700.20 thereof. [0006] Therefore, there exists a need for a dosage package, capable of housing both frangible and/or non-frangible dosage forms, which can be easily modified to provide varying designs ranging from extremely child proof designs to designs that are easily operable. SUMMARY OF THE INVENTION [0007] The packages of the invention are preferably blister packages that require bending in order to access an unsealed 3 area of a lidding material sheet. Upon access of the unsealed area, a user can peel away the lidding material from a blister sheet, thereby exposing any dosage forms housed therein. In certain embodiments, the present invention relates to packages for housing frangible or friable pharmaceutical dosage forms. In other embodiments, the blister packages for friable dosage forms are child resistant. In others, the blister packages are useful for packaging non-frangible tablets. [0008] A first aspect of the present invention is a blister package for housing dosage forms, both frangible and non-frangible. The package includes, a unitary blister sheet or "bottom" defining at least one unit package region, the at least one unit package region including a recess (used synonymously with bubble, blister and well) having an open top and a flange surrounding the recess. Each recess (in the case of more than one recess) may accommodate one or more dosage forms. The package also includes a unitary sheet of lidding material or "top" peelably sealed to the flanges. The blister sheet and the sheet of lidding material further define at least one unsealed area for facilitating peeling of the lidding material from the blister sheet so as to provide access to the recess. These unsealed areas are preferably only accessible by a user upon the bending of at least a portion of the blister sheet and/or the sheet of lidding material in the proximity of the unsealed area. It is noted that if the blister sheet and/or the sheet of lidding material is scored or perforated, they do not technically bend. However, for purposes of the present invention, the term bend will encompass the folding over of such an area. In a preferred embodiment, the bending of at least a portion of the blister sheet and/or the sheet of lidding material splits or forces separation of at least a portion of the unsealed lidding material along a score line, line of weakness or line of perforations, thus allowing access to the unsealed areas. 4 [0009] Another aspect of the present invention is another blister package for housing dosage forms, both frangible and non-frangible. The blister package according to this aspect includes a blister sheet including at least one recess having an open top and a flange surrounding the recess and a sheet of lidding material including perforations. The sheet of lidding material is peelably sealed to at least a portion of the flanges and defines at least one unsealed area between the blister sheet and the sheet of lidding material. In this embodiment, perforations are located along at least a portion of the at least one unsealed area and bending of the blister package in the proximity of the perforations allows for splitting or separation of the perforations and access of the at least one unsealed area. [0010] Yet another aspect of the present invention is a method of removing a dosage form from a blister package. The method according to this aspect includes providing a blister package having a blister sheet and a sheet of lidding material, where the blister sheet and the sheet of lidding material define at least one unit package region including at least one recess and at least one inaccessible unsealed area. The method also includes the steps of bending at least a portion of the blister package to allow access of the otherwise inaccessible unsealed area, grasping at least a portion of the lidding material adjacent the unsealed area, pealing away at least a portion of the lidding material to reveal at least one dosage form disposed in the recess and removing the at least one dosage form. [0011] In certain preferred embodiments, the blister package is constituted of materials and configured to retard access through ripping, tearing, chewing, puncture, and the like, especially by children too young to know better. Indeed, because of the very adaptable design of the packages of the present invention, it is possible to make packages which can 5 cover a variety of degrees of child proofing. [0012] In another preferred embodiment according to the present invention, the blister package is designed to reduce breakage of a frangible tablet housed therein. The frangible dosage forms disposed in each recess of the preferred blisters engages the walls of each recess so that the walls hold the dosage form away from the bottom of the recess and adjacent the lidding material. This aspect protects the dosage form from damage by preventing shifting of the dosage form during transport. An empty space between each dosage form and the bottom of the recess in which the dosage form is disposed cushions the dosage form from impact when the package is dropped. The recesses of the package and the dosage forms disposed in the recesses may have essentially any shape. For example, the dosage forms may be disk-shaped tablets, oblong capsules or square-shaped pills. Similarly, shapes for recesses include circular, oblong, polygonal or star shapes in the plane of the blister sheet. [0013] Furthermore, the walls and bottom of the recesses may define a shape in the form of a surface of revolution, about a vertical axis normal to the flange surrounding each of the recesses. For example, the recesses may have a curved, cup-like shape. Where the dosage forms are disc-shaped, they may each have an edge which contacts the walls of the recess in which each dosage form is disposed. The edge and walls define an annular region of contact coaxial with the vertical axis of the recess. The edge of such a disc-shaped dosage form may comprise a bevel which contacts the walls of the recess. The annular region of contact prevents shifting of the dosage form within the blister and the damage to the dosage form associated with such shifting. [0014] By varying certain attributes of the various elements of blister packages according to the present invention, a package can be provided for a multitude of different uses. 6 Utilizing different modes of attaching the lidding material sheet to the blister sheet, specifically, utilizing different adhesives in different amounts, may vary the difficulty required in pealing apart the two elements. Essentially, the stronger the adhesive and/or the more adhesive utilized, the harder it is to peel away the lidding material sheet. Similarly, varying certain dimensions of the blister packages may tailor the level of difficulty of grasping and bending. For instance, adjusting other dimensions tailors the amount of lidding material that is required to be pealed away to reveal the recess. Varying the thickness or type of the materials utilized in constructing both the blister sheet and lidding material sheet may also vary the difficultly in the bending operation, as well as the difficulty in pealing away the lidding material sheet. Certainly the type and thickness of these materials can have a significant effect on the ability to rip or chew through a package. While the blister package can include many different combinations of differing elements, three distinct embodiments are envisioned, a child proof design, an extremely child proof design, and an easy access design. The fact that all are possible from the same design speaks to the flexibility of the novel design of the present invention. [0015] The child proof design requires a balance of the attributes of the elements just described and others such that the package is sufficiently difficult to open by children. Such a package is preferably useful for both frangible and non-frangible dosage forms, which are dangerous to children if ingested. The extremely child proof design requires a balance of the attributes of the elements such that the package is extremely difficult to open by a child. This extremely child proof design may also house frangible and non-frangible dosage forms, which are deadly to children if ingested. Such a package may prove more difficult for an adult also, but the 7 danger of the dosage forms housed therein requires the heightened level of protection. Finally, the easy access design requires a balance of the attributes of the elements such that the package may be relatively easy to open. A package of this type may be useful in housing less dangerous or typical over the counter medications or vitamins. [0016] As one of ordinary skill in the art will appreciate, the packaging in accordance with the present invention is highly versatile and is capable of being formatted such that it is child proof, extremely child proof or easily accessible. The materials and dimensions that can be used to construct these packages are highly dependent upon the overall objective. However, some general statements can be made regarding packaging design in accordance with the present invention. For example, all of the packages in accordance with the present invention should be blister packages having one or more blisters per card. Each blister package should, at least in a preferred embodiment, assist in reducing breakage during packaging, transport and storage. Each package will preferably be openable by peeling back the lidding layer based on exposure of a graspable edge of the lidding material accomplished by bending a portion of the package. [0017] Furthermore, generally speaking, the greater the degree of child resistance desired, the greater the degree of distance for the placement of the recess relative to any one edge of the card. Also, the distance X between the edge of the recess and the closest portion of the unsealed area edge revealed during bending will be maximized. The more child resistant the package, generally the greater the thickness and/or ruggedness of the material (s) used in one or more of the layers. And also, generally the greater the degree of child resistance desired, the more aggressive the adhesive used. Of course, it may be possible to use very small amounts of a relatively aggressive adhesive and still provide an easily 8 openable package in accordance with the present invention. Similarly, the use of a very thin polymer material layers, which is excessively rugged, resistant to bending, ripping and relatively impervious to a child's chewing, might be completely adequate, notwithstanding its relatively diminutive thickness. The distance X may also be relatively small when a particularly aggressive adhesive is used or when an easily openable blister package is desired. Indeed, by adjusting the variables discussed herein, it may be possible to use a relatively unagressive adhesive and yet provide a child resistant blister package. Thus, the package design according to the present invention is extremely versatile. [0018] The packaging, according to different embodiment of the present invention can be rated as child resistant packages such as packages generally referred to in the industry as "F4", "F3", "F2" or "Fl" packages. These monikers are given to packages that pass certain tests relating to how many children can gain access to the dosage forms housed in the packages in a certain amount of time. Typically, the number following the "P" refers to the number of tablets that would cause serious personal injury or serious illness to a twenty five pound child if ingested. For example, one such test begins with a base of fifty children, their goal being to access the dosage form housed in the package. The children are first given the packages without instructions to access the dosage forms. The children are given five minutes to attempt to gain access. After the five minutes expires, the children are asked to stop, at which point they are shown the proper steps to take in order to gain access to the dosage forms. Thereafter, the children are given an additional five minutes to work with the package. According to this one test, an Fl package would be one in which no more than five children can gain access to one pill during the ten minute period. A package would be given the F2 label if no more than five children can gain access to two pills. 9 And, an F4 package would be one in which no more than five children can gain access to four pills in the ten minute period. While the above described test is one well known test utilized by the packaging industry, there are clearly many different tests that can be conducted in order to properly rate packages. These tests are generally done in accordance with 16 C.F.R. § 1700.00-1700.20. [0019] Certain embodiments according to the present invention may be rated as high as the well known industry standard known as "Fl" packaging. For example, the extremely child proof embodiment discussed above would likely garner such an Fl rating. Other embodiments according to the present invention may be referred to by the also well know "F4" moniker. Finally, certain embodiments of the present invention may be referred to as F8 Plus or easy access. More particularly, the child proof design as discussed above would likely be rated as an F4 package, while the easy access design discussed above would likely be rated as an F8 plus package. [0020] Of course, the robust and versatile design of the present invention allows the creation of tablet packages which are extremely child resistant and thus difficult for children to open, as well as packages which would be extremely easy for children to open. Which package is appropriate, however, is largely dependent upon the type of dosage form and active ingredient to be packaged thereby. Tablets containing, for example, symethacone, are relatively inert and the concern necessary for overdosing would be relatively small. On the other hand, opiates such as fentanyl may be extremely dangerous if not handled properly under a doctor's care and can be particularly dangerous to children. Accordingly, packages which are more child resistant would be appropriate. BRIEF DESCRIPTION OF THE DRAWINGS [0021] FIG. 1 is a bottom plan view of the blister package according to the present invention. 10 [0022] FIG. 2 is a top plan view of the blister package of FIG. 1. [0023] FIG. 3 is a cross-sectional side view of a unit package region of the blister package taken along line A-A of FIG. 1. [0024] FIG. 4 is top plan view of a unit package region of the blister package of FIG. 1. [0025] FIG. 5 is a cross-sectional side view of a unit package region with a section bent about an axis B to allow for pealing of a lidding material from a blister sheet. [0026] FIG. 6 is a bottom plan view of the blister package according to another embodiment of the present invention. [0027] FIG. 7 is a top plan view of the blister package of FIG. 6. [0028] FIG. 8 is top plan view of a unit package region of the blister package of FIG. 6. DETAILED DESCRIPTION [0029] A blister package 10 in accordance with an embodiment of the present invention is shown in FIGS. 1-5. Blister package 10 is configured so as to create a container for tablets that requires the bending of a portion of the elements of package 10 in order to gain access to the dosage forms contained therein. Blister package 10 preferably includes a blister sheet 12 and a sheet of lidding material 14. In various embodiments of the present invention, blister package 10 may be configured and dimensioned to allow for different levels of access to a dosage form contained therein, by varying the attributes of the various elements. This will be further discussed below. [0030] In a preferred embodiment of the present invention, as shown in FIG. 1, blister sheet 12 includes a plurality of unit package regions 16, such as the four regions shown in the figure. However, it is contemplated that a blister package 10 according to other embodiments *f the present invention can 11 include any number of unit package regions 16, including a single unit package region 16. Each unit package region 16 further includes a recess 18 and a flange 20 surrounding the recess. As best shown in PIG. 3, each recess 18 is dimensioned and configured to house a tablet or dosage form 1, and includes an open top 22 and a closed bottom 24. Recess 18 may be dimensioned or configured so as to house dosage forms 1 of varying sizes and/or shapes. In certain embodiments, recess 18 is circular (as shown in the figures) and has a diameter of one (1) inch or less. However, this diameter may be more preferably three quarters (3/4) of an inch or less, or most preferably one half (1/2) of an inch or less. Similarly, recess 18 can vary in shape to house dosage forms of similar varying shapes. For example, recess 18 may be of an oblong shape to house pills of an oblong shape, although other shapes are contemplated, including polygonal or star shapes. Additionally, recess 18 may be configured to house more than one dosage form. [0031] It is contemplated that the design of blister package 10 may also provide specific protection for frangible dosage forms by including recesses 18 that cooperate with such dosage forms to prevent shifting of the frangible dosage forms during transport and/or cushioning in the event of impact from the dropping of the package. Commonly assigned U.S. Patent No. 6,155,423 to Katzner et al. ("the '423 patent"), the disclosure of which is hereby incorporated by reference herein, teaches one solution to this problem. The '423 patent discloses a blister package having a peelable layer which when pealed away allows for access to the dosage form. Therefore, the '423 patent provides a user accessibility to his or her frangible dosage form without the possibility of damaging the dosage form. The blister package of the '423 is also designed to help protect the tablet during storage, shipment and use. The present invention may utilize a similar design. For example, 12 in certain embodiments, frangible or friable dosage forms may be disposed in each recess 18 of blister sheet 12 such that the dosage forms engage the walls of each recess 18, and the walls hold dosage form 1 away from closed bottom 24 and adjacent lidding material 14. Such a configuration is best shown in FIG. 3. This design also protects any dosage form housed therein from damage by preventing shifting of the dosage form during transport or other movement typically imparted by a user. For example, an empty space between each dosage form and closed bottom 24 cushions the dosage form from impact if and when package 10 is dropped or otherwise jarred. [0032] Furthermore, the walls and closed bottom 24 of recess 18 may define a shape in the form of a surface of revolution, about a vertical axis normal to flange 20 surrounding each of the recesses 18. For example, recesses 18 may have a curved, cup-like shape. Where the dosage forms are disc-shaped, they may each have an edge which contacts the walls of recess 18 in which each dosage form is disposed. The edge and walls preferably define an annular region of contact coaxial with the vertical axis of recess 18. The edge of such a disc-shaped dosage form may comprise a bevel which contacts the walls of recess 18. The annular region of contact prevents shifting of the dosage form within the blister and the damage to the dosage form associated with such shifting. [0033] Lidding material sheet 14 (best shown in FIG. 2) is preferably a unitary sheet that overlies recesses 18 and is peelably attached to flanges 20, thereby covering any dosage forms 1 housed within recesses 18. As best shown in FIG. 2, lidding material sheet 14 includes lines of weakness 26. Essentially, lines of weakness 26 are lines of holes, scores or perforations through lidding material 14 that allow the lidding material to be more easily torn away. It should be noted that lines of weakness 26 may extend through lidding material sheet 14 and blister sheet 12, as shown in the FIGS. In embodiments 13 that include such a configuration, unit package regions 16 may be removed from other unit package regions. In fact, lines of weakness 2 6 in these embodiments define the size and shape of unit package regions 16. It should also be noted that providing lidding material sheet 14 with lines of weakness 26 may, in certain manufacturing processes, cause such to extend through blister sheet 12. [0034] According to the present invention, lidding material sheet 14 is preferably glued to blister sheet 12. However, other modes of attaching lidding material sheet 14 to blister sheet 12 are contemplated, such as heat sealing, RP sealing and the like. While lidding material sheet 14 is substantially connected to blister sheet 12, there exists unconnected, unsealed or unglued areas 28. These areas (shown in the FIGS, with phantom lines) are essentially areas where blister sheet 12 is not glued or otherwise attached to lidding material sheet 14. This, of course, is in addition to the inserted areas defined by the recesses. As shown in FIGS. 1, 2 and 4, unsealed areas 28 are specifically shaped to allow both easy access by a user and easy tearing away of lidding material sheet 14 from blister sheet 12. For example, the shape of unsealed areas 28 as shown in the FIGS. 1-5 is such that the thumb and forefinger of a user can easily grasp lidding material 14. However, it is contemplated that unsealed areas 28 may be of any shape including, but not limited to, circular, semi circular, triangular, squared shaped, or other polygons. Perforations 30 preferably extend along at least a portion of unsealed areas 28. Perforations 30 are essentially a shorter version of lines of weakness 26, which do not extend to any of the edges of unit package regions 16. This important because such a configuration reduces the tearing of any portion of a given unit package region 16 and retards access without bonding. Thus, the only way unsealed areas 2 8 can be accessed is by the bending method discussed below. Once again, as 14 mentioned above in the discussion on lines of weakness 26, perforations 30 may extend through both lidding material sheet 14 and blister sheet 12. However, once again, the particular configuration depends upon the manufacturing process. It is also contemplated that perforations 3 0 may be constructed so as to be deeper or shallower in different embodiments. This may allow for different accessing conditions as will be discussed further below. In addition, perforations 30 are preferably formed such that lidding material sheet 14 remains flat sided. In other words, a user is preferably unable to grasp an edge created by perforations 30 or any other part of lidding material sheet 14. This, in turn, prevents the removal of lidding material sheet 14 from blister sheet 12, absent the performance of other steps which will be discussed below. [0035] As best shown in FIGS. 4 and 5, blister package 10 must be bent along an axis B in order for unglued areas 28 to be accessed by a user. Axis B is preferably an axis extending along the line of perforations 30. Upon bending, blister package 10 may be separated into two separate portions, Y and Z, residing on either side of axis B. In operation, a user grasps portions Y and Z in either hand and bends them towards one another so as to split lidding material sheet 14 along perforations 30. It is noted that blister package 10 should be bent so that lidding material sheet 14 remains on the outside of the bend. This bent state, with a split lidding material sheet 14, is best shown in FIG. 5. Given the fact that perforations 30 are formed through lidding material sheet 14 along a portion which is at least partially unsealed, the splitting of lidding material sheet 14 along perforations 3 0 allows for a user to then access or grasp unsealed area 28. As shown in FIG. 5, a user can quite easily grasp at least a portion of unsealed area 28 when perforations 30 are split. Essentially, the bending of blister package 10 causes lidding material sheet 14 to move into a non-flat sided state, or one 15 in which a user is able to grasp a portion of the lidding material adjacent unsealed area 28 in the proximity of axis 13. Thereafter, the user can peal away the portion of lidding material sheet 14 that resides in portion Z, which, in turn, exposes recess 18. Therefore, dosage form 1 can be easily removed. The effort required in pealing away lidding material sheet 14 depends upon, amongst other things, the mode of attachment of lidding material sheet 14 to blister sheet 12, the thickness and rigidity of the blister sheet 12 and or lidding sheet 14, the size at the unsealed area 28, the amount of space one has to grasp the package (portion Y) and the distance that the lidding sheet 14 must be pulled to provide access to the recess. [0036] FIGs 6-8 depict an additional embodiment according to the present invention that is a blister package 110 having a differently shaped unsealed or unglued area 128. The shape of unsealed areas 128 as shown in FIGS. 6-8 is such that the thumb and forefinger of a user can more easily grasp lidding material 14, and subsequent tearing of lidding material 14 away from blister sheet 12 is guided to uncover the entirety of recess 18. These guiding unsealed areas 12 8 allow for a more uniform tear to be made over and around recess 118. The construction and operation of blister package 110 is preferably similar to the above described package 10, except for the guiding unsealed areas 128. [0037] It has been discovered that varying certain attributes of the various elements of blister package 10 may provide for different types and different levels of functionality. For example, utilizing different modes of attaching lidding material sheet 14 to blister sheet 12, specifically, utilizing different amounts of different adhesives, may vary the difficulty required in pealing apart the two elements. As one example, the stronger the adhesive utilized, the harder it is to peel away lidding material sheet 16 14 from blister sheet 12. Conversely, using relatively little of even a strong adhesive may prove useful for an easy access application. Varying the length of portions Y and Z may also determine the level of difficulty of accessing dosage form 1. For example, varying the length of portions Y and Z may make the bending operation more or less difficult, by providing smaller or larger portions for a user to manipulate. A thick layer of a rigid material could also make it difficult to bend blister package 10 so as to reveal the unsealed area 28. When combined with a relatively short Y, providing little room to grip may make it difficult to bend portion Y and provide access. Similarly, recess 18 may be situated at a varying distance X (shown in FIGS. 4 and 5) from unsealed area 28. The greater the distance X, the relatively more difficult it is to peal away lidding material sheet 14 depending, of course, on the type of adhesive and the amount of adhesive used. Finally, varying the thickness or type of the materials utilized in constructing both blister sheet 12 and lidding material sheet 14 may also vary the difficultly in the bending operation, as well as the difficulty in pealing away lidding material sheet 14. As one will appreciate, many of the possible ways to construct the packages of the invention depend upon the use contemplated and the interdependence of a number of elements as discussed herein. [0038] While blister package 10 can include many different combinations of differing elements, three distinct embodiments will be discussed further below. Each of the embodiments may be configured to house frangible or non-frangible dosage forms. It is contemplated that varying any or all of the above discussed attributes may provide a blister package in accordance with any of these embodiments. In other words, it is possible to achieve a blister package that adheres to a specific embodiment by providing different combinations of element attributes. 17 [0039] The first embodiment that will be discussed can best be described as a child proof design that may be utilized with any type of dosage form. Such a design might be, for example, known in the art as an F4 package, as discussed above. In this embodiment the length of portion Y may be decreased, while at the same time increasing the length of portion Z. Shortening the length of portion Y with respect to portion Z makes it more difficult to manipulate blister package 10 to perform the aforementioned bending step, thus making it more difficult to split the lidding material along perforations 30 and ultimately accessing dosage form 1. The lengthening of portion Z may allow for the increase of distance X. This necessarily also increases the difficulty in removing lidding material 14 to access dosage form 1. Essentially, the farther away unglued area 28 is from recess 18, the more difficult it is to peal away lidding material sheet 14. Lengthening of portion Z also allows for recess 18 to be situated a greater distance from the various edges of blister package 10. Thus, making the package less susceptible to improper access of dosage form 1, such as by biting, tearing or ripping. [0040] In accordance with this embodiment, it is also contemplated, in addition to varying the lengths of portions Y and Z, that the mode of attachment of lidding material sheet 14 to blister sheet 12, the materials and the thickness of the materials utilized in blister package 10 may also be varied. For example, stronger adhesive may be utilized to increase the effort required in pealing away lidding material sheet 14. One such adhesive is an adhesive supplied by Alcan Pharma Center of Shelbyville, KY ("Alcan") under the number 4563 and may be utilized to create such an F4 package according to this embodiment. Similarly, utilizing thicker or stronger materials may increase the difficulty in bending blister package 10. The thicker or stronger materials are also more resistant to biting, chewing, tearing and the like. - [0041] While, there are indeed many different combinations that may provide a blister package in accordance with this first embodiment, certain preferred embodiments are envisioned. Once again however, in accordance with this embodiment, it is contemplated that varying any of the attributes in order to make accessing dosage form 1 more difficult, may allow for other attributes to be varied in order to make accessing dosage form 1 easier. In other words, blister packages in accordance with this first embodiment are achieved through a balance of the different attributes. For example, if distance X is increased, a weaker adhesive may be utilized while still providing a blister package in accordance with this embodiment. [0042] The second embodiment that will be discussed can best be described as an extremely child proof design that is specially suited for housing highly dangerous dosage forms (e.g. Fl) . Designs in accordance with this embodiment should comply with standards set for other extremely child proof packages. For example, packages according to this embodiment should prevent a certain amount of children from accessing the dosage forms contained therein, in a certain amount of time, as per the previously discussed Fl rating testing. In this second embodiment, like in the first embodiment, the length of portion Y may be decreased, while at the same time increasing the length of portion Z. Once again, shortening the length of portion Y with respect to portion Z makes it more difficult to manipulate blister package 10 to perform the bending step of blister package 10 and the lengthening of portion Z may increase distance X and the situation of recess 18 from the edges of unit package region 16. In this embodiment, the length of portion Y should be decreased so as to make it extremely difficult to manipulate blister package 10, and the length of portion Z should be increased so as to make it extremely difficult to peal away lidding material sheet 14. Like that of the first embodiment, both the mode of attachment 19 of lidding material sheet 14 to blister sheet 12 and the materials and thicknesses of materials utilized in blister package 10 may also be varied. Stronger adhesive should be utilized to increase the effort required in pealing away lidding material sheet 14, and thicker or stronger materials should be utilized to increase the difficulty in bending blister package 10. [0043] While, there are indeed many different combinations that may provide a blister package that is extremely child proof, a preferred embodiment is envisioned. For example, an extremely child proof embodiment of blister package 10 may include an overall length of approximately four (4) inches, and most preferably of 4.0 95 inches, and an overall width of approximately two and a half (2.5) inches, and most preferably of 2.577 inches, as well as a portion Y having a length of about 10 mm, a portion Z having a length of about 42 mm, and a distance X having a length of about 10.3 mm. In this preferred embodiment, blister sheet 12 may be constructed of material supplied by Alcan and offered as PCS technical and material specification no. 92011 ("the 92011 material) having a thickness of approximately 205 mm. The 92011 material includes, several different individual layers, for example, approximately 60 mm of PVC film, approximately 25 mm of polyamide film, approximately 60 mm of aluminum foil and approximately 60 mm of additional PVC film, which are preferably at least joined together by suitable adhesives. Lidding material sheet 14, on the other hand, may be constructed of PCS technical and material specification nos. 15144 having a thickness of approximately 37 mm or 15127 having a thickness of approximately 37 mm. Both of these materials are also supplied by Alcan, and preferably include a paper layer, an approximately 12 mm thick polyester film, an approximately 25 mm thick aluminum foil layer and a heat seal coating. In addition, this embodiment may utilize adhesive also supplied by 20 Alcan under the number 4516 for attaching lidding material sheet 14 to blister sheet 12. Once again, blister packages in accordance with this extremely child proof embodiment are achieved through a balance of the different attributes. While these specifics are provided for a single preferred embodiment, it is noted that other materials or dimensions may be utilized. For example, the selection of adhesive for use with this second embodiment may be chosen by selecting an adhesive that provides a connection strength that does not fall below 454 g/in. , as per an ASTM F88 test method. In one instance, use of the identical materials and construction, and replacement of adhesive 4516 with adhesive 4563 (also supplied by Alcan) provided an "F4" package while the use of adhesive 4516 provided an "Fl" package. [0044] Conversely, a third embodiment can be designed for easy access or easy peel (e.g., for packaging designed to house less dangerous dosage forms). For example, such a package may be considered an F8 plus package, as further discussed above. A blister package in accordance with this third embodiment may be useful in housing over the counter medications and/or vitamins. In this third embodiment, the length of portion Y may be increased, while at the same time decreasing the length of portion Z. Unlike the previously discussed embodiments, the lengthening of portion Y with respect to portion Z makes it easier to manipulate blister package 10 and the shortening of portion Z may allow for the decrease of distance X, thus lessening the difficulty in removing lidding material 14 to access dosage form 1. Also in this embodiment, the length of portion Y should be decreased and the length of portion Z should be decreased so as to make it relatively easy to bend blister package 10 and to peal away lidding material sheet 14, by all persons. Like that of the first and second embodiments, both the mode of attachment of lidding material sheet 14 to blister sheet 12 and the materials and material thicknesses 21 utilized in blister package 10 may also be varied. In addition, in this embodiment, weaker adhesive may be utilized to decrease the effort required in pealing away lidding material sheet 14, and weaker or thinner materials may be utilized to decrease the difficulty in bending blister package 10. [0045] while, there are indeed many different combinations that may provide a blister package that is designed for easy access, a preferred embodiment is envisioned. In this embodiment, providing weaker attributes is key. The package should have an overall user-friendly design that provides for easy use. For example, such a user-friendly package could employ unsealed covers like those depicted in the embodiment of FIGS. 6-8, and referred to as elements 12 8. Once again, the attributes may be varied such that decreasing the difficulty provided by certain attributes may allow for the increase in difficulty provided by others. For instance, a blister package in accordance with this embodiment may utilize an extremely weak adhesive. For this type of package, the material or thickness of material may not need to be weaker or decreased all that much. [0046] It is contemplated that, in addition to the above discussed attributes, other attributes of other elements of blister package 10, and blister package 110, can be varied to provide differing packages. For example, unsealed areas 28, 128 may be configured and/or sized to provide a more difficult or easier grasping by a user. Similarly, perforations 30, 130 may be designed such that splitting of the lidding material is a more difficult or easier task. Nonetheless, blister package 10 provides an extraordinarily functional package design for housing all sorts of dosage forms or pills. [0047] Finally, one preferred formation method of the aforementioned blister packages 10, 110 and the packaging process of dosages forms 1 therein will be described. It is to -21- 22 be understood that many different suitable processes may be utilized in accordance with the present invention, and the following is but one preferred method. In such a method/process, sheets of material for forming blister sheet 12 and lidding material 14 are preferably received in roll form and fed or loaded onto a blister machine. It is noted that such machines are well-known in the art. The material forming blister sheet 12 is then preferably moved to a forming station where recesses 18 are formed into the material by tools such as forming plugs. Tablets 1 are then preferably placed into each open recess 18 of blister sheet 12. [0048] With recesses 18 each containing one or more tablets 1, blister sheet 12 is then preferably moved to a sealing station where upper and lower sealing plates may be utilized to seal lidding material 14 to blister sheet 12. The aforementioned sealing plates preferably utilize heat and pressure over the course of a certain dwell time (cycles/speed) to heat a suitable adhesive (like those described above) to seal lidding material 14 to blister sheet 12. Subsequent to this sealing step, desired perforations may be formed in the package, and individual blister cards 10 (with multiple recesses 18) may be punched out. It is noted that the formed perforations may be useful in this punch out procedure, but may also remain in the final blister package 10 as discussed above. Ultimately, the individual packages 10 are preferably delivered to final packaging stations via conveyors or the like. [0049] The dosage forms, usually tablets, which can be packaged using the present invention are not at all limited by the type of tablet or the type of active pharmaceutical ingredient ("API") used therein. These API's include, without limitation, analgesics, anti-inflammatories, antipyretics, antibiotics, antimicrobials, anxiolytics, laxatives, anorexics, antihistamines, antidepressants, antiasthmatics, antidiuretics, antiflatuents, antimigraine agents, antispasmodics, sedatives, 23 antihyperactives, antihypertensives, tranquilizers, decongestants, beta blockers, peptides, proteins, oligonucleotides and other substances of biological origin, and combinations thereof. Also contemplated are the drugs and pharmaceutically active ingredients described in Mantelle, U.S. Pat. No. 5,234,957, in columns 18 through 21. That text of Mantelle is hereby incorporated by reference. Any of the forgoing API's can be used in the form of any salt, hydrate, solvate, polymorph, or individual optical isomer, and any mixture thereof. [0050] In particular, opiates, drugs used to treat pain, drugs used in psychiatry or in the treatment of schizophrenia, such as clozapine and cytotoxic substances are particularly preferred. Also preferred is any API which is intended to treat the elderly or any API which requires the use of a child- proof package, and more particularly an nFl" package. [0051] Legal opiates which may be packaged according to the invention include prescription drugs such as, without limitation, alfentanil, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, codeine phosphate, desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levorphanol, lofentanil, meperidine, meptazinol, metazocine, methadone, metopon, morphine, morphine hydrochloride, morphine sulfate, myrophine, nalbuphine, narceien, nicomorphine, norlevorphanol, normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone, papveretum, pentazocine, phenadoxone, phenazocine, phenoperidine, piminodine, piritramide, proheptazine, promedol, propirm, propoxyphene, remifentanil, 24 sufentanil and tilidine. The class of compounds generally known as opiates also includes illicit drugs such as heroin and cocaine. Opiates in accordance with the present invention include those identified above as well as any listed as controlled substances pursuant to 21 C.P.R. § 13 08.12. Opiates are given to patients for a variety of reasons, most frequently for pain mitigation of one type or another. [0052] A cytotoxic substance includes any agent that kills cells. These substances are generally used in the treatment of malignant and other diseases. They are designed to destroy rapidly growing cancer cells. They have been shown to be mutagenic, carcinogenic and/or teratogenic, either in treatment doses or animal and bacterial assays. Cytotoxic drugs that interfere with critical cellular processes including DNA, RNA, and protein synthesis, have been conjugated to antibodies and subsequently used for in vivo therapy. Such drugs, include, but are not limited to: [0053] i) intercalating agents, in particular doxorubicin (Adriamycin), daunorubicin, epirubicin, idarubicin, zorubicin, aclarubicin, pirarubicin, acridine, mitoxanthrone, actinomycin D, eptilinium acetate; [0054] ii) alkylating agents chosen from platinum derivatives (cisplatin, carboplatin, oxaliplatin); [0055] iii) a compound chosen from the other groups of alkylating agents-, cyclophosphamide, ifosfamide, chlormetrine, melphalan, chlorambucil, estramustine, busulfan, mitomycin C, nitrosoureas: BCNU (carmustine), CCNU (lomustine), fotemustine, streptozotocin, triazines or derivatives: procarbazine, dacarbazine, pipobroman, ethyleneimines: altretamine, triethylene-thio-phosphoramide, [0056] iv) a compound chosen from the other groups of anti- metabolic agents: antifolic agents: methotrexate, raltitrexed, antipyrimidine agents: 5-fluorouracil (5-FU), cytarabine (Ara- C), hydroxyurea antipurine agents: purinethol, thioguanine, -24-5 pentostatin, cladribine, cytotoxic nucleoside synthesis inducers: gemcitabine, [0057] v) a compound chosen from the other groups of tubulin-affinity agents, vinca alkaloids which disrupt the mitotic spindle: vincristine, vinblastine, vindesine, navelbine, agents which block the depolymerization of the mitotic spindle: paclitaxel, docetaxel, agents which induce DNA cleavage by inhibition of topoisomerase II: etoposide, teniposide, topoisomerase I inhibitors which induce DNA cleavage: topotecan, irinotecan, [0058] vi) a DNA splitting or fragmenting agent, such as bleomycin, [0059] vii) one of the following compounds: plicamycin, L- asparaginase, mitoguazone, dacarbazine, [0060] viii) an anticancer progestative steroid; medroxy- progesterone, megestrol, [0061] ix) an anticancer estrogen steroid: diethylstilbestrol; tetrasodium fosfestrol, [0062] x) an antiestrogen agent: tamoxifen, droloxifen, raloxifen, aminoglutethimide, [0063] xi) a steroidal antiandrogenic agent (eg cyproterone) or a non-steroidal antiandrogenic agent (flutamide, nilutamide). [0064] In addition to the API's mentioned herein, the dosage forms of the invention can, in addition or instead, include vitamins, minerals and dietary supplements. As used in this disclosure, the term "vitamin" refers to trace organic substances that are required in the diet. For the purposes of the present invention, the term "vitamin(s)" includes, without limitation, thiamine, riboflavin, nicotinic acid, pantothenic acid, pyridoxine, biotin, folic acid, vitamin B.sub.12, lipoic acid, ascorbic acid, vitamin A, vitamin D, vitamin E and vitamin K. Also included within the term "vitamin" are the -25- 26 coenzymes thereof. Coenzymes are specific chemical forms of vitamins. Coenzymes include thiamine pyrophosphates (TPP), flavin mononucleotide (FMM), flavin adenine dinucleotide (FAD), Nicotinamide adenine dinucleotide (NAD), Nicotinamide adenine dinucleotide phosphate (NADP), Coenzyme A (CoA), pyridoxal phosphate, biocytin, tetrahydrofolic acid, coenzyme B.sub.12, lipoyllysine, 11-cis-retinal, and 1,25- dihydroxycholecalciferol. The term "vitamin(s)" also includes choline, carnitine, and alpha, beta, and gamma carotenes. [0065] The term "mineral" refers to inorganic substances, metals, and the like required in the human diet. Thus, the term "mineral" as used herein includes, without limitation, calcium, (calcium carbonate), iron, zinc, selenium, copper, iodine, magnesium, phosphorus, chromium and the like, and mixtures thereof. The term "dietary supplement" as used herein means a substance which has an appreciable nutritional effect when administered in small amounts. Dietary supplements include, without limitation, such ingredients as bee pollen, bran, wheat germ, kelp, cod liver oil, ginseng, and fish oils, amino-acids, proteins and mixtures thereof. As will be appreciated, dietary supplements may incorporate vitamins and minerals. [0066] In general, the amount of active ingredient incorporated in each tablet or dosage form (API, vitamin, mineral, dietary supplement and the like), may be selected according to known principles of pharmacy. An effective amount of API is specifically contemplated. By the term "effective amount," it is understood that, with respect, to for example, a "pharmaceutically effective amount" is contemplated. A "pharmaceutically effective amount" is the amount or quantity of a drug or API which is sufficient to elicit the required or desired therapeutic response, or in other words, the amount which is sufficient to elicit an appreciable biological response when administered to a patient. As used with reference to a vitamin or mineral, the term "effective amount" means an -26- 27 amount at least about 10% of the United States Recommended Daily Allowance ("RDA") of that particular ingredient for a patient. For example, if an intended ingredient is vitamin C, then an effective amount of vitamin C would include an amount of vitamin C sufficient to provide 10% or more of the RDA. Typically, where the tablet includes a mineral or vitamin, it will incorporate higher amounts, preferably about 100% or more of the applicable RDA. [0067] The amount of active ingredient used can vary greatly. Of course, the size of the dosage form, the requirements of other ingredients, and the number of, for example, tablets which constitute a single dose will all impact the upper limit on the amount of pharmacologically active ingredient which can be used. However, generally, the active ingredient is provided in an amount of between greater than zero and about 80% by weight of the finished tablet and, more preferably, in a range of between greater than zero and about 60% by weight thereof. Put in other terms, the active ingredient can be included in an amount of between about 1 microgram to about 2 grams, and more preferably between about 0.01 and about 1000 milligrams per dosage form, i.e., per tablet. [0068] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. INDUSTRIAL APPLICABILITY [0069] The present invention enjoys wide industrial applicability including, but not limited to, providing -27- 28 packaging for medications, especially those in tablet form and frangible tablet form. -28- We claim: 1. A blister package comprising: a unitary blister sheet defining at least one unit package region, the at least one unit package region including a recess having an open top and a flange surrounding the recess; and a unitary sheet of lidding material peelably sealed to the flanges, wherein said blister sheet and said sheet of lidding material further define unsealed areas for facilitating peeling of said lidding material from said blister sheet, said unsealed areas being accessible by a user upon the bending of at least a portion of said blister sheet and said sheet of lidding material. 2. The blister package according to claim 1, wherein said blister sheet includes four unit package regions. 3. The blister package according to claim 2, wherein each unit package region is removable from said blister package. 4. The blister package according to claim 3, further including lines of weakness, wherein each unit package region is defined by the lines of weakness. 5. The blister package according to claim 1, wherein said sheet of lidding material further includes perforations for accessing the unsealed areas. 6. The blister package according to claim 1, wherein the recess includes walls and a closed bottom. 7. The blister package according to claim 6, wherein a dosage form may be disposed in the recess so that the walls hold the dosage form away from the closed bottom and adjacent said lidding material so that there is an empty space between each dosage form and the closed bottom of the recess. -29- 8. A packaged dosage form including a package as claimed in claim 1 and a plurality of pharmaceutical dosage forms disposed in the recesses. 9. The packaged dosage form claimed in claim 8, wherein the pharmaceutical dosage forms are fentanyl. 10. A method of removing a dosage form from a blister package comprising: providing said blister package having a blister sheet and a sheet of lidding material, wherein the blister sheet and the sheet of lidding material define at least one unit package region including at least one recess and at least one inaccessible unsealed area; bending at least a portion of said blister package to allow access of the unsealed area; grasping at least a portion of the unsealed area; pealing away at least a portion of the lidding material to reveal at least one dosage form disposed in the recess; and removing the at least one dosage form. 11. The method according to claim 10, further comprising the step of separating at least one unit package region from other unit package regions. 12. The method according to claim 10, wherein said bending step includes splitting a portion of the lidding material along a line of perforations. 13. A blister package comprising: a blister sheet including at least one recess having an open top and a flange surrounding the recess; and a sheet of lidding material including perforations, said sheet of lidding material peelably sealed to at least a 31 portion of the flanges and defining at least one unsealed area between said blister sheet and said sheet of lidding material, wherein the perforations are located along at least a portion of the at least one unsealed area and bending of said blister package allows for splitting of the perforations and access of the at least one unsealed area. 14. The blister package according to claim 13, wherein said blister sheet includes a plurality of unit package regions, each unit package region including at least one recess and at least one flange surrounding the at least one recess. 15. The blister package according to claim 13, wherein the at least one recess includes walls and a closed bottom. 16. The blister package according to claim 15, wherein a dosage form may be disposed in the recess so that the walls hold the dosage form away from the closed bottom and adjacent said lidding material so that there is an empty space between each dosage form and the closed bottom of the recess. Dated this 10th day of August, 2007. (Kshitij Saxena) of Amarchand & Mangaldas & SureshA. Shroff & Co. Attorneys for the Applicant CIMA LABS INC. -31- A blister package (10) and method of removing a dosage form (1) from a blister package (10) are disclosed. In one embodiment, the blister package (10) includes a unitary blister sheet (12) and a unitary sheet of lidding material (14). The lidding sheet (14) is peelably sealed to the blister sheet (12), and includes unsealed areas (28) for facilitating the peeling of the lidding material (14) from the blister sheet (12). The unsealed areas (28) are preferably only accessible upon a bending of the blister package (10).

Full Text

BEND AND PEEL TABLET PACKAGE
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of the filing
date of United States Provisional Patent Application No.
60/644,393 filed January 14, 2005, the disclosure of which is
hereby incorporated herein by reference
BACKGROUND OF THE INVENTION
[0002] Many people, as part of their daily routine, take
various types of medication. Some may take several different
types of pharmaceutical dosage forms in a given period. These
pharmaceutical dosage forms may include pills, capsules,
tablets, liquids and the like. As with many industries for
which a tangible product is offered for sale, packaging is an
issue. Often times, the manner in which a product is offered
is a deciding factor in whether or not a purchase is made.
This situation is no different in the pharmaceutical field.
But other concerns may also drive the style of packaging in the
pharmaceutical industry.
[0003] One packaging concern is the nature of the dosage
form. Some tablets, for example, are frangible, friable or
breakable (used synonymously) . Such dosage forms may be easily
damaged both during transport of the package and by a user upon
opening. The disclosures of commonly assigned U.S. Pat. Nos.
5,178,878 and 5,223,264, which are hereby incorporated by
reference herein, describe relatively soft tablets which are
susceptible to this type of damage. Tablets which fall into
this category tend to have a low hardness and high friability,
and may include very soft tablets with a hardness below about
15 Newtons.
[0004] Standard dosage forms are typically packaged in
blister packages, which are comprised of multi-layered sheets
of material having pockets, blisters or wells for containing
the dosage forms. One type of conventional blister packages
includes packages having a foil layer through which a user of
2

the package must push the tablet, thereby breaking the foil.
An example of such a conventional blister package is shown in
U.S. Pat. No. 4,158,411 to Hall et al., the disclosure of which
is hereby incorporated by reference herein. While this type of
package is sufficient for packaging standard dosage forms,
packaging of frangible dosage forms in such a package would
cause damage to the frangible dosage form when attempting to
push it through the foil layer. These types of packages are
also generally not child proof.
[0005] Another concern with the packaging of pharmaceutical
dosage forms, whether they are frangible dosage forms or not,
relates to safety. Child proof or child resistant packaging is
often very desirable for the packaging of dosage forms.
Clearly, a big concern with having medication in the home is
the possibility of a child gaining access to it. On the other
hand, child-proof packages may also be quite difficult to open
by the elderly, handicapped or people in great pain. There
needs to be a balance struck, therefore, between safety and
ease of use. Packages that are more difficult for children to
open than, for example, the elderly are therefore highly
desirable. In addition, not all child proof packaging is the
same. Packaging is often rated based on the number of children
who can gain access to the drug in five minutes. One example
of testing procedure standards for achieving these ratings is
set forth in 16 C.P.R., and in particular § 1700.00 through
1700.20 thereof.
[0006] Therefore, there exists a need for a dosage package,
capable of housing both frangible and/or non-frangible dosage
forms, which can be easily modified to provide varying designs
ranging from extremely child proof designs to designs that are
easily operable.
SUMMARY OF THE INVENTION
[0007] The packages of the invention are preferably blister
packages that require bending in order to access an unsealed
3

area of a lidding material sheet. Upon access of the unsealed
area, a user can peel away the lidding material from a blister
sheet, thereby exposing any dosage forms housed therein. In
certain embodiments, the present invention relates to packages
for housing frangible or friable pharmaceutical dosage forms.
In other embodiments, the blister packages for friable dosage
forms are child resistant. In others, the blister packages are
useful for packaging non-frangible tablets.
[0008] A first aspect of the present invention is a blister
package for housing dosage forms, both frangible and
non-frangible. The package includes, a unitary blister sheet
or "bottom" defining at least one unit package region, the at
least one unit package region including a recess (used
synonymously with bubble, blister and well) having an open top
and a flange surrounding the recess. Each recess (in the case
of more than one recess) may accommodate one or more dosage
forms. The package also includes a unitary sheet of lidding
material or "top" peelably sealed to the flanges. The blister
sheet and the sheet of lidding material further define at least
one unsealed area for facilitating peeling of the lidding
material from the blister sheet so as to provide access to the
recess. These unsealed areas are preferably only accessible by
a user upon the bending of at least a portion of the blister
sheet and/or the sheet of lidding material in the proximity of
the unsealed area. It is noted that if the blister sheet
and/or the sheet of lidding material is scored or perforated,
they do not technically bend. However, for purposes of the
present invention, the term bend will encompass the folding
over of such an area. In a preferred embodiment, the bending
of at least a portion of the blister sheet and/or the sheet of
lidding material splits or forces separation of at least a
portion of the unsealed lidding material along a score line,
line of weakness or line of perforations, thus allowing access
to the unsealed areas.
4

[0009] Another aspect of the present invention is another
blister package for housing dosage forms, both frangible and
non-frangible. The blister package according to this aspect
includes a blister sheet including at least one recess having
an open top and a flange surrounding the recess and a sheet of
lidding material including perforations. The sheet of lidding
material is peelably sealed to at least a portion of the
flanges and defines at least one unsealed area between the
blister sheet and the sheet of lidding material. In this
embodiment, perforations are located along at least a portion
of the at least one unsealed area and bending of the blister
package in the proximity of the perforations allows for
splitting or separation of the perforations and access of the
at least one unsealed area.
[0010] Yet another aspect of the present invention is a
method of removing a dosage form from a blister package. The
method according to this aspect includes providing a blister
package having a blister sheet and a sheet of lidding material,
where the blister sheet and the sheet of lidding material
define at least one unit package region including at least one
recess and at least one inaccessible unsealed area. The method
also includes the steps of bending at least a portion of the
blister package to allow access of the otherwise inaccessible
unsealed area, grasping at least a portion of the lidding
material adjacent the unsealed area, pealing away at least a
portion of the lidding material to reveal at least one dosage
form disposed in the recess and removing the at least one
dosage form.
[0011] In certain preferred embodiments, the blister package
is constituted of materials and configured to retard access
through ripping, tearing, chewing, puncture, and the like,
especially by children too young to know better. Indeed,
because of the very adaptable design of the packages of the
present invention, it is possible to make packages which can
5

cover a variety of degrees of child proofing.
[0012] In another preferred embodiment according to the
present invention, the blister package is designed to reduce
breakage of a frangible tablet housed therein. The frangible
dosage forms disposed in each recess of the preferred blisters
engages the walls of each recess so that the walls hold the
dosage form away from the bottom of the recess and adjacent the
lidding material. This aspect protects the dosage form from
damage by preventing shifting of the dosage form during
transport. An empty space between each dosage form and the
bottom of the recess in which the dosage form is disposed
cushions the dosage form from impact when the package is
dropped. The recesses of the package and the dosage forms
disposed in the recesses may have essentially any shape. For
example, the dosage forms may be disk-shaped tablets, oblong
capsules or square-shaped pills. Similarly, shapes for
recesses include circular, oblong, polygonal or star shapes in
the plane of the blister sheet.
[0013] Furthermore, the walls and bottom of the recesses may
define a shape in the form of a surface of revolution, about a
vertical axis normal to the flange surrounding each of the
recesses. For example, the recesses may have a curved,
cup-like shape. Where the dosage forms are disc-shaped, they
may each have an edge which contacts the walls of the recess in
which each dosage form is disposed. The edge and walls define
an annular region of contact coaxial with the vertical axis of
the recess. The edge of such a disc-shaped dosage form may
comprise a bevel which contacts the walls of the recess. The
annular region of contact prevents shifting of the dosage form
within the blister and the damage to the dosage form associated
with such shifting.
[0014] By varying certain attributes of the various elements
of blister packages according to the present invention, a
package can be provided for a multitude of different uses.
6

Utilizing different modes of attaching the lidding material
sheet to the blister sheet, specifically, utilizing different
adhesives in different amounts, may vary the difficulty
required in pealing apart the two elements. Essentially, the
stronger the adhesive and/or the more adhesive utilized, the
harder it is to peel away the lidding material sheet.
Similarly, varying certain dimensions of the blister packages
may tailor the level of difficulty of grasping and bending. For
instance, adjusting other dimensions tailors the amount of
lidding material that is required to be pealed away to reveal
the recess. Varying the thickness or type of the materials
utilized in constructing both the blister sheet and lidding
material sheet may also vary the difficultly in the bending
operation, as well as the difficulty in pealing away the
lidding material sheet. Certainly the type and thickness of
these materials can have a significant effect on the ability to
rip or chew through a package. While the blister package can
include many different combinations of differing elements,
three distinct embodiments are envisioned, a child proof
design, an extremely child proof design, and an easy access
design. The fact that all are possible from the same design
speaks to the flexibility of the novel design of the present
invention.
[0015] The child proof design requires a balance of the
attributes of the elements just described and others such that
the package is sufficiently difficult to open by children.
Such a package is preferably useful for both frangible and
non-frangible dosage forms, which are dangerous to children if
ingested. The extremely child proof design requires a balance
of the attributes of the elements such that the package is
extremely difficult to open by a child. This extremely child
proof design may also house frangible and non-frangible dosage
forms, which are deadly to children if ingested. Such a
package may prove more difficult for an adult also, but the
7

danger of the dosage forms housed therein requires the
heightened level of protection. Finally, the easy access
design requires a balance of the attributes of the elements
such that the package may be relatively easy to open. A
package of this type may be useful in housing less dangerous or
typical over the counter medications or vitamins.
[0016] As one of ordinary skill in the art will appreciate,
the packaging in accordance with the present invention is
highly versatile and is capable of being formatted such that it
is child proof, extremely child proof or easily accessible.
The materials and dimensions that can be used to construct
these packages are highly dependent upon the overall objective.
However, some general statements can be made regarding
packaging design in accordance with the present invention. For
example, all of the packages in accordance with the present
invention should be blister packages having one or more
blisters per card. Each blister package should, at least in a
preferred embodiment, assist in reducing breakage during
packaging, transport and storage. Each package will preferably
be openable by peeling back the lidding layer based on exposure
of a graspable edge of the lidding material accomplished by
bending a portion of the package.
[0017] Furthermore, generally speaking, the greater the
degree of child resistance desired, the greater the degree of
distance for the placement of the recess relative to any one
edge of the card. Also, the distance X between the edge of the
recess and the closest portion of the unsealed area edge
revealed during bending will be maximized. The more child
resistant the package, generally the greater the thickness
and/or ruggedness of the material (s) used in one or more of the
layers. And also, generally the greater the degree of child
resistance desired, the more aggressive the adhesive used. Of
course, it may be possible to use very small amounts of a
relatively aggressive adhesive and still provide an easily
8

openable package in accordance with the present invention.
Similarly, the use of a very thin polymer material layers,
which is excessively rugged, resistant to bending, ripping and
relatively impervious to a child's chewing, might be completely
adequate, notwithstanding its relatively diminutive thickness.
The distance X may also be relatively small when a particularly
aggressive adhesive is used or when an easily openable blister
package is desired. Indeed, by adjusting the variables
discussed herein, it may be possible to use a relatively
unagressive adhesive and yet provide a child resistant blister
package. Thus, the package design according to the present
invention is extremely versatile.
[0018] The packaging, according to different embodiment of
the present invention can be rated as child resistant packages
such as packages generally referred to in the industry as "F4",
"F3", "F2" or "Fl" packages. These monikers are given to
packages that pass certain tests relating to how many children
can gain access to the dosage forms housed in the packages in a
certain amount of time. Typically, the number following the
"P" refers to the number of tablets that would cause serious
personal injury or serious illness to a twenty five pound child
if ingested. For example, one such test begins with a base of
fifty children, their goal being to access the dosage form
housed in the package. The children are first given the
packages without instructions to access the dosage forms. The
children are given five minutes to attempt to gain access.
After the five minutes expires, the children are asked to stop,
at which point they are shown the proper steps to take in order
to gain access to the dosage forms. Thereafter, the children
are given an additional five minutes to work with the package.
According to this one test, an Fl package would be one in which
no more than five children can gain access to one pill during
the ten minute period. A package would be given the F2 label
if no more than five children can gain access to two pills.
9

And, an F4 package would be one in which no more than five
children can gain access to four pills in the ten minute
period. While the above described test is one well known test
utilized by the packaging industry, there are clearly many
different tests that can be conducted in order to properly rate
packages. These tests are generally done in accordance with 16
C.F.R. § 1700.00-1700.20.
[0019] Certain embodiments according to the present
invention may be rated as high as the well known industry
standard known as "Fl" packaging. For example, the extremely
child proof embodiment discussed above would likely garner such
an Fl rating. Other embodiments according to the present
invention may be referred to by the also well know "F4"
moniker. Finally, certain embodiments of the present invention
may be referred to as F8 Plus or easy access. More
particularly, the child proof design as discussed above would
likely be rated as an F4 package, while the easy access design
discussed above would likely be rated as an F8 plus package.
[0020] Of course, the robust and versatile design of the
present invention allows the creation of tablet packages which
are extremely child resistant and thus difficult for children
to open, as well as packages which would be extremely easy for
children to open. Which package is appropriate, however, is
largely dependent upon the type of dosage form and active
ingredient to be packaged thereby. Tablets containing, for
example, symethacone, are relatively inert and the concern
necessary for overdosing would be relatively small. On the
other hand, opiates such as fentanyl may be extremely dangerous
if not handled properly under a doctor's care and can be
particularly dangerous to children. Accordingly, packages
which are more child resistant would be appropriate.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a bottom plan view of the blister package
according to the present invention.
10

[0022] FIG. 2 is a top plan view of the blister package of
FIG. 1.
[0023] FIG. 3 is a cross-sectional side view of a unit
package region of the blister package taken along line A-A of
FIG. 1.
[0024] FIG. 4 is top plan view of a unit package region of
the blister package of FIG. 1.
[0025] FIG. 5 is a cross-sectional side view of a unit
package region with a section bent about an axis B to allow for
pealing of a lidding material from a blister sheet.
[0026] FIG. 6 is a bottom plan view of the blister package
according to another embodiment of the present invention.
[0027] FIG. 7 is a top plan view of the blister package of
FIG. 6.
[0028] FIG. 8 is top plan view of a unit package region of
the blister package of FIG. 6.
DETAILED DESCRIPTION
[0029] A blister package 10 in accordance with an embodiment
of the present invention is shown in FIGS. 1-5. Blister
package 10 is configured so as to create a container for
tablets that requires the bending of a portion of the elements
of package 10 in order to gain access to the dosage forms
contained therein. Blister package 10 preferably includes a
blister sheet 12 and a sheet of lidding material 14. In
various embodiments of the present invention, blister package
10 may be configured and dimensioned to allow for different
levels of access to a dosage form contained therein, by varying
the attributes of the various elements. This will be further
discussed below.
[0030] In a preferred embodiment of the present invention,
as shown in FIG. 1, blister sheet 12 includes a plurality of
unit package regions 16, such as the four regions shown in the
figure. However, it is contemplated that a blister package 10
according to other embodiments *f the present invention can
11

include any number of unit package regions 16, including a
single unit package region 16. Each unit package region 16
further includes a recess 18 and a flange 20 surrounding the
recess. As best shown in PIG. 3, each recess 18 is dimensioned
and configured to house a tablet or dosage form 1, and includes
an open top 22 and a closed bottom 24. Recess 18 may be
dimensioned or configured so as to house dosage forms 1 of
varying sizes and/or shapes. In certain embodiments, recess 18
is circular (as shown in the figures) and has a diameter of one
(1) inch or less. However, this diameter may be more
preferably three quarters (3/4) of an inch or less, or most
preferably one half (1/2) of an inch or less. Similarly,
recess 18 can vary in shape to house dosage forms of similar
varying shapes. For example, recess 18 may be of an oblong
shape to house pills of an oblong shape, although other shapes
are contemplated, including polygonal or star shapes.
Additionally, recess 18 may be configured to house more than
one dosage form.
[0031] It is contemplated that the design of blister package
10 may also provide specific protection for frangible dosage
forms by including recesses 18 that cooperate with such dosage
forms to prevent shifting of the frangible dosage forms during
transport and/or cushioning in the event of impact from the
dropping of the package. Commonly assigned U.S. Patent No.
6,155,423 to Katzner et al. ("the '423 patent"), the disclosure
of which is hereby incorporated by reference herein, teaches
one solution to this problem. The '423 patent discloses a
blister package having a peelable layer which when pealed away
allows for access to the dosage form. Therefore, the '423
patent provides a user accessibility to his or her frangible
dosage form without the possibility of damaging the dosage
form. The blister package of the '423 is also designed to help
protect the tablet during storage, shipment and use. The
present invention may utilize a similar design. For example,
12

in certain embodiments, frangible or friable dosage forms may
be disposed in each recess 18 of blister sheet 12 such that the
dosage forms engage the walls of each recess 18, and the walls
hold dosage form 1 away from closed bottom 24 and adjacent
lidding material 14. Such a configuration is best shown in
FIG. 3. This design also protects any dosage form housed
therein from damage by preventing shifting of the dosage form
during transport or other movement typically imparted by a
user. For example, an empty space between each dosage form and
closed bottom 24 cushions the dosage form from impact if and
when package 10 is dropped or otherwise jarred.
[0032] Furthermore, the walls and closed bottom 24 of recess
18 may define a shape in the form of a surface of revolution,
about a vertical axis normal to flange 20 surrounding each of
the recesses 18. For example, recesses 18 may have a curved,
cup-like shape. Where the dosage forms are disc-shaped, they
may each have an edge which contacts the walls of recess 18 in
which each dosage form is disposed. The edge and walls
preferably define an annular region of contact coaxial with the
vertical axis of recess 18. The edge of such a disc-shaped
dosage form may comprise a bevel which contacts the walls of
recess 18. The annular region of contact prevents shifting of
the dosage form within the blister and the damage to the dosage
form associated with such shifting.
[0033] Lidding material sheet 14 (best shown in FIG. 2) is
preferably a unitary sheet that overlies recesses 18 and is
peelably attached to flanges 20, thereby covering any dosage
forms 1 housed within recesses 18. As best shown in FIG. 2,
lidding material sheet 14 includes lines of weakness 26.
Essentially, lines of weakness 26 are lines of holes, scores or
perforations through lidding material 14 that allow the lidding
material to be more easily torn away. It should be noted that
lines of weakness 26 may extend through lidding material sheet
14 and blister sheet 12, as shown in the FIGS. In embodiments
13

that include such a configuration, unit package regions 16 may
be removed from other unit package regions. In fact, lines of
weakness 2 6 in these embodiments define the size and shape of
unit package regions 16. It should also be noted that
providing lidding material sheet 14 with lines of weakness 26
may, in certain manufacturing processes, cause such to extend
through blister sheet 12.
[0034] According to the present invention, lidding material
sheet 14 is preferably glued to blister sheet 12. However,
other modes of attaching lidding material sheet 14 to blister
sheet 12 are contemplated, such as heat sealing, RP sealing and
the like. While lidding material sheet 14 is substantially
connected to blister sheet 12, there exists unconnected,
unsealed or unglued areas 28. These areas (shown in the FIGS,
with phantom lines) are essentially areas where blister sheet
12 is not glued or otherwise attached to lidding material sheet
14. This, of course, is in addition to the inserted areas
defined by the recesses. As shown in FIGS. 1, 2 and 4,
unsealed areas 28 are specifically shaped to allow both easy
access by a user and easy tearing away of lidding material
sheet 14 from blister sheet 12. For example, the shape of
unsealed areas 28 as shown in the FIGS. 1-5 is such that the
thumb and forefinger of a user can easily grasp lidding
material 14. However, it is contemplated that unsealed areas
28 may be of any shape including, but not limited to, circular,
semi circular, triangular, squared shaped, or other polygons.
Perforations 30 preferably extend along at least a portion of
unsealed areas 28. Perforations 30 are essentially a shorter
version of lines of weakness 26, which do not extend to any of
the edges of unit package regions 16. This important because
such a configuration reduces the tearing of any portion of a
given unit package region 16 and retards access without
bonding. Thus, the only way unsealed areas 2 8 can be accessed
is by the bending method discussed below. Once again, as
14

mentioned above in the discussion on lines of weakness 26,
perforations 30 may extend through both lidding material sheet
14 and blister sheet 12. However, once again, the particular
configuration depends upon the manufacturing process. It is
also contemplated that perforations 3 0 may be constructed so as
to be deeper or shallower in different embodiments. This may
allow for different accessing conditions as will be discussed
further below. In addition, perforations 30 are preferably
formed such that lidding material sheet 14 remains flat sided.
In other words, a user is preferably unable to grasp an edge
created by perforations 30 or any other part of lidding
material sheet 14. This, in turn, prevents the removal of
lidding material sheet 14 from blister sheet 12, absent the
performance of other steps which will be discussed below.
[0035] As best shown in FIGS. 4 and 5, blister package 10
must be bent along an axis B in order for unglued areas 28 to
be accessed by a user. Axis B is preferably an axis extending
along the line of perforations 30. Upon bending, blister
package 10 may be separated into two separate portions, Y and
Z, residing on either side of axis B. In operation, a user
grasps portions Y and Z in either hand and bends them towards
one another so as to split lidding material sheet 14 along
perforations 30. It is noted that blister package 10 should be
bent so that lidding material sheet 14 remains on the outside
of the bend. This bent state, with a split lidding material
sheet 14, is best shown in FIG. 5. Given the fact that
perforations 30 are formed through lidding material sheet 14
along a portion which is at least partially unsealed, the
splitting of lidding material sheet 14 along perforations 3 0
allows for a user to then access or grasp unsealed area 28. As
shown in FIG. 5, a user can quite easily grasp at least a
portion of unsealed area 28 when perforations 30 are split.
Essentially, the bending of blister package 10 causes lidding
material sheet 14 to move into a non-flat sided state, or one
15

in which a user is able to grasp a portion of the lidding
material adjacent unsealed area 28 in the proximity of axis 13.
Thereafter, the user can peal away the portion of lidding
material sheet 14 that resides in portion Z, which, in turn,
exposes recess 18. Therefore, dosage form 1 can be easily
removed. The effort required in pealing away lidding material
sheet 14 depends upon, amongst other things, the mode of
attachment of lidding material sheet 14 to blister sheet 12,
the thickness and rigidity of the blister sheet 12 and or
lidding sheet 14, the size at the unsealed area 28, the amount
of space one has to grasp the package (portion Y) and the
distance that the lidding sheet 14 must be pulled to provide
access to the recess.
[0036] FIGs 6-8 depict an additional embodiment according to
the present invention that is a blister package 110 having a
differently shaped unsealed or unglued area 128. The shape of
unsealed areas 128 as shown in FIGS. 6-8 is such that the thumb
and forefinger of a user can more easily grasp lidding material
14, and subsequent tearing of lidding material 14 away from
blister sheet 12 is guided to uncover the entirety of recess
18. These guiding unsealed areas 12 8 allow for a more uniform
tear to be made over and around recess 118. The construction
and operation of blister package 110 is preferably similar to
the above described package 10, except for the guiding unsealed
areas 128.
[0037] It has been discovered that varying certain
attributes of the various elements of blister package 10 may
provide for different types and different levels of
functionality. For example, utilizing different modes of
attaching lidding material sheet 14 to blister sheet 12,
specifically, utilizing different amounts of different
adhesives, may vary the difficulty required in pealing apart
the two elements. As one example, the stronger the adhesive
utilized, the harder it is to peel away lidding material sheet
16

14 from blister sheet 12. Conversely, using relatively little
of even a strong adhesive may prove useful for an easy access
application. Varying the length of portions Y and Z may also
determine the level of difficulty of accessing dosage form 1.
For example, varying the length of portions Y and Z may make
the bending operation more or less difficult, by providing
smaller or larger portions for a user to manipulate. A thick
layer of a rigid material could also make it difficult to bend
blister package 10 so as to reveal the unsealed area 28. When
combined with a relatively short Y, providing little room to
grip may make it difficult to bend portion Y and provide
access. Similarly, recess 18 may be situated at a varying
distance X (shown in FIGS. 4 and 5) from unsealed area 28. The
greater the distance X, the relatively more difficult it is to
peal away lidding material sheet 14 depending, of course, on
the type of adhesive and the amount of adhesive used. Finally,
varying the thickness or type of the materials utilized in
constructing both blister sheet 12 and lidding material sheet
14 may also vary the difficultly in the bending operation, as
well as the difficulty in pealing away lidding material sheet
14. As one will appreciate, many of the possible ways to
construct the packages of the invention depend upon the use
contemplated and the interdependence of a number of elements as
discussed herein.
[0038] While blister package 10 can include many different
combinations of differing elements, three distinct embodiments
will be discussed further below. Each of the embodiments may
be configured to house frangible or non-frangible dosage forms.
It is contemplated that varying any or all of the above
discussed attributes may provide a blister package in
accordance with any of these embodiments. In other words, it
is possible to achieve a blister package that adheres to a
specific embodiment by providing different combinations of
element attributes.
17

[0039] The first embodiment that will be discussed can best
be described as a child proof design that may be utilized with
any type of dosage form. Such a design might be, for example,
known in the art as an F4 package, as discussed above. In this
embodiment the length of portion Y may be decreased, while at
the same time increasing the length of portion Z. Shortening
the length of portion Y with respect to portion Z makes it more
difficult to manipulate blister package 10 to perform the
aforementioned bending step, thus making it more difficult to
split the lidding material along perforations 30 and ultimately
accessing dosage form 1. The lengthening of portion Z may
allow for the increase of distance X. This necessarily also
increases the difficulty in removing lidding material 14 to
access dosage form 1. Essentially, the farther away unglued
area 28 is from recess 18, the more difficult it is to peal
away lidding material sheet 14. Lengthening of portion Z also
allows for recess 18 to be situated a greater distance from the
various edges of blister package 10. Thus, making the package
less susceptible to improper access of dosage form 1, such as
by biting, tearing or ripping.
[0040] In accordance with this embodiment, it is also
contemplated, in addition to varying the lengths of portions Y
and Z, that the mode of attachment of lidding material sheet 14
to blister sheet 12, the materials and the thickness of the
materials utilized in blister package 10 may also be varied.
For example, stronger adhesive may be utilized to increase the
effort required in pealing away lidding material sheet 14. One
such adhesive is an adhesive supplied by Alcan Pharma Center of
Shelbyville, KY ("Alcan") under the number 4563 and may be
utilized to create such an F4 package according to this
embodiment. Similarly, utilizing thicker or stronger materials
may increase the difficulty in bending blister package 10. The
thicker or stronger materials are also more resistant to
biting, chewing, tearing and the like.
-

[0041] While, there are indeed many different combinations
that may provide a blister package in accordance with this
first embodiment, certain preferred embodiments are envisioned.
Once again however, in accordance with this embodiment, it is
contemplated that varying any of the attributes in order to
make accessing dosage form 1 more difficult, may allow for
other attributes to be varied in order to make accessing dosage
form 1 easier. In other words, blister packages in accordance
with this first embodiment are achieved through a balance of
the different attributes. For example, if distance X is
increased, a weaker adhesive may be utilized while still
providing a blister package in accordance with this embodiment.
[0042] The second embodiment that will be discussed can best
be described as an extremely child proof design that is
specially suited for housing highly dangerous dosage forms
(e.g. Fl) . Designs in accordance with this embodiment should
comply with standards set for other extremely child proof
packages. For example, packages according to this embodiment
should prevent a certain amount of children from accessing the
dosage forms contained therein, in a certain amount of time, as
per the previously discussed Fl rating testing. In this second
embodiment, like in the first embodiment, the length of portion
Y may be decreased, while at the same time increasing the
length of portion Z. Once again, shortening the length of
portion Y with respect to portion Z makes it more difficult to
manipulate blister package 10 to perform the bending step of
blister package 10 and the lengthening of portion Z may
increase distance X and the situation of recess 18 from the
edges of unit package region 16. In this embodiment, the
length of portion Y should be decreased so as to make it
extremely difficult to manipulate blister package 10, and the
length of portion Z should be increased so as to make it
extremely difficult to peal away lidding material sheet 14.
Like that of the first embodiment, both the mode of attachment
19

of lidding material sheet 14 to blister sheet 12 and the
materials and thicknesses of materials utilized in blister
package 10 may also be varied. Stronger adhesive should be
utilized to increase the effort required in pealing away
lidding material sheet 14, and thicker or stronger materials
should be utilized to increase the difficulty in bending
blister package 10.
[0043] While, there are indeed many different combinations
that may provide a blister package that is extremely child
proof, a preferred embodiment is envisioned. For example, an
extremely child proof embodiment of blister package 10 may
include an overall length of approximately four (4) inches, and
most preferably of 4.0 95 inches, and an overall width of
approximately two and a half (2.5) inches, and most preferably
of 2.577 inches, as well as a portion Y having a length of
about 10 mm, a portion Z having a length of about 42 mm, and a
distance X having a length of about 10.3 mm. In this preferred
embodiment, blister sheet 12 may be constructed of material
supplied by Alcan and offered as PCS technical and material
specification no. 92011 ("the 92011 material) having a
thickness of approximately 205 mm. The 92011 material includes,
several different individual layers, for example, approximately
60 mm of PVC film, approximately 25 mm of polyamide film,
approximately 60 mm of aluminum foil and approximately 60 mm of
additional PVC film, which are preferably at least joined
together by suitable adhesives. Lidding material sheet 14, on
the other hand, may be constructed of PCS technical and
material specification nos. 15144 having a thickness of
approximately 37 mm or 15127 having a thickness of
approximately 37 mm. Both of these materials are also supplied
by Alcan, and preferably include a paper layer, an
approximately 12 mm thick polyester film, an approximately 25
mm thick aluminum foil layer and a heat seal coating. In
addition, this embodiment may utilize adhesive also supplied by
20

Alcan under the number 4516 for attaching lidding material
sheet 14 to blister sheet 12. Once again, blister packages in
accordance with this extremely child proof embodiment are
achieved through a balance of the different attributes. While
these specifics are provided for a single preferred embodiment,
it is noted that other materials or dimensions may be utilized.
For example, the selection of adhesive for use with this second
embodiment may be chosen by selecting an adhesive that provides
a connection strength that does not fall below 454 g/in. , as
per an ASTM F88 test method. In one instance, use of the
identical materials and construction, and replacement of
adhesive 4516 with adhesive 4563 (also supplied by Alcan)
provided an "F4" package while the use of adhesive 4516
provided an "Fl" package.
[0044] Conversely, a third embodiment can be designed for
easy access or easy peel (e.g., for packaging designed to house
less dangerous dosage forms). For example, such a package may
be considered an F8 plus package, as further discussed above.
A blister package in accordance with this third embodiment may
be useful in housing over the counter medications and/or
vitamins. In this third embodiment, the length of portion Y
may be increased, while at the same time decreasing the length
of portion Z. Unlike the previously discussed embodiments, the
lengthening of portion Y with respect to portion Z makes it
easier to manipulate blister package 10 and the shortening of
portion Z may allow for the decrease of distance X, thus
lessening the difficulty in removing lidding material 14 to
access dosage form 1. Also in this embodiment, the length of
portion Y should be decreased and the length of portion Z
should be decreased so as to make it relatively easy to bend
blister package 10 and to peal away lidding material sheet 14,
by all persons. Like that of the first and second embodiments,
both the mode of attachment of lidding material sheet 14 to
blister sheet 12 and the materials and material thicknesses
21

utilized in blister package 10 may also be varied. In
addition, in this embodiment, weaker adhesive may be utilized
to decrease the effort required in pealing away lidding
material sheet 14, and weaker or thinner materials may be
utilized to decrease the difficulty in bending blister package
10.
[0045] while, there are indeed many different combinations
that may provide a blister package that is designed for easy
access, a preferred embodiment is envisioned. In this
embodiment, providing weaker attributes is key. The package
should have an overall user-friendly design that provides for
easy use. For example, such a user-friendly package could
employ unsealed covers like those depicted in the embodiment of
FIGS. 6-8, and referred to as elements 12 8. Once again, the
attributes may be varied such that decreasing the difficulty
provided by certain attributes may allow for the increase in
difficulty provided by others. For instance, a blister package
in accordance with this embodiment may utilize an extremely
weak adhesive. For this type of package, the material or
thickness of material may not need to be weaker or decreased
all that much.
[0046] It is contemplated that, in addition to the above
discussed attributes, other attributes of other elements of
blister package 10, and blister package 110, can be varied to
provide differing packages. For example, unsealed areas 28,
128 may be configured and/or sized to provide a more difficult
or easier grasping by a user. Similarly, perforations 30, 130
may be designed such that splitting of the lidding material is
a more difficult or easier task. Nonetheless, blister package
10 provides an extraordinarily functional package design for
housing all sorts of dosage forms or pills.
[0047] Finally, one preferred formation method of the
aforementioned blister packages 10, 110 and the packaging
process of dosages forms 1 therein will be described. It is to
-21-
22

be understood that many different suitable processes may be
utilized in accordance with the present invention, and the
following is but one preferred method. In such a
method/process, sheets of material for forming blister sheet 12
and lidding material 14 are preferably received in roll form
and fed or loaded onto a blister machine. It is noted that
such machines are well-known in the art. The material forming
blister sheet 12 is then preferably moved to a forming station
where recesses 18 are formed into the material by tools such as
forming plugs. Tablets 1 are then preferably placed into each
open recess 18 of blister sheet 12.
[0048] With recesses 18 each containing one or more tablets
1, blister sheet 12 is then preferably moved to a sealing
station where upper and lower sealing plates may be utilized to
seal lidding material 14 to blister sheet 12. The
aforementioned sealing plates preferably utilize heat and
pressure over the course of a certain dwell time (cycles/speed)
to heat a suitable adhesive (like those described above) to
seal lidding material 14 to blister sheet 12. Subsequent to
this sealing step, desired perforations may be formed in the
package, and individual blister cards 10 (with multiple
recesses 18) may be punched out. It is noted that the formed
perforations may be useful in this punch out procedure, but may
also remain in the final blister package 10 as discussed above.
Ultimately, the individual packages 10 are preferably delivered
to final packaging stations via conveyors or the like.
[0049] The dosage forms, usually tablets, which can be
packaged using the present invention are not at all limited by
the type of tablet or the type of active pharmaceutical
ingredient ("API") used therein. These API's include, without
limitation, analgesics, anti-inflammatories, antipyretics,
antibiotics, antimicrobials, anxiolytics, laxatives, anorexics,
antihistamines, antidepressants, antiasthmatics, antidiuretics,
antiflatuents, antimigraine agents, antispasmodics, sedatives,
23

antihyperactives, antihypertensives, tranquilizers,
decongestants, beta blockers, peptides, proteins,
oligonucleotides and other substances of biological origin, and
combinations thereof. Also contemplated are the drugs and
pharmaceutically active ingredients described in Mantelle, U.S.
Pat. No. 5,234,957, in columns 18 through 21. That text of
Mantelle is hereby incorporated by reference. Any of the
forgoing API's can be used in the form of any salt, hydrate,
solvate, polymorph, or individual optical isomer, and any
mixture thereof.
[0050] In particular, opiates, drugs used to treat pain,
drugs used in psychiatry or in the treatment of schizophrenia,
such as clozapine and cytotoxic substances are particularly
preferred. Also preferred is any API which is intended to
treat the elderly or any API which requires the use of a child-
proof package, and more particularly an nFl" package.
[0051] Legal opiates which may be packaged according to the
invention include prescription drugs such as, without
limitation, alfentanil, alphaprodine, anileridine,
benzylmorphine, bezitramide, buprenorphine, butorphanol,
clonitazene, codeine, codeine phosphate, desomorphine,
dextromoramide, dezocine, diampromide, dihydrocodeine,
dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol,
dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate,
dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene,
ethylmorphine, etonitazene, fentanyl, hydrocodone,
hydromorphone, hydroxypethidine, isomethadone, ketobemidone,
levorphanol, lofentanil, meperidine, meptazinol, metazocine,
methadone, metopon, morphine, morphine hydrochloride, morphine
sulfate, myrophine, nalbuphine, narceien, nicomorphine,
norlevorphanol, normethadone, normorphine, norpipanone, opium,
oxycodone, oxymorphone, papveretum, pentazocine, phenadoxone,
phenazocine, phenoperidine, piminodine, piritramide,
proheptazine, promedol, propirm, propoxyphene, remifentanil,
24

sufentanil and tilidine. The class of compounds generally known
as opiates also includes illicit drugs such as heroin and
cocaine. Opiates in accordance with the present invention
include those identified above as well as any listed as
controlled substances pursuant to 21 C.P.R. § 13 08.12. Opiates
are given to patients for a variety of reasons, most frequently
for pain mitigation of one type or another.
[0052] A cytotoxic substance includes any agent that kills
cells. These substances are generally used in the treatment of
malignant and other diseases. They are designed to destroy
rapidly growing cancer cells. They have been shown to be
mutagenic, carcinogenic and/or teratogenic, either in treatment
doses or animal and bacterial assays. Cytotoxic drugs that
interfere with critical cellular processes including DNA, RNA,
and protein synthesis, have been conjugated to antibodies and
subsequently used for in vivo therapy. Such drugs, include, but
are not limited to:
[0053] i) intercalating agents, in particular doxorubicin
(Adriamycin), daunorubicin, epirubicin, idarubicin, zorubicin,
aclarubicin, pirarubicin, acridine, mitoxanthrone, actinomycin
D, eptilinium acetate;
[0054] ii) alkylating agents chosen from platinum
derivatives (cisplatin, carboplatin, oxaliplatin);
[0055] iii) a compound chosen from the other groups of
alkylating agents-, cyclophosphamide, ifosfamide, chlormetrine,
melphalan, chlorambucil, estramustine, busulfan, mitomycin C,
nitrosoureas: BCNU (carmustine), CCNU (lomustine), fotemustine,
streptozotocin, triazines or derivatives: procarbazine,
dacarbazine, pipobroman, ethyleneimines: altretamine,
triethylene-thio-phosphoramide,
[0056] iv) a compound chosen from the other groups of anti-
metabolic agents: antifolic agents: methotrexate, raltitrexed,
antipyrimidine agents: 5-fluorouracil (5-FU), cytarabine (Ara-
C), hydroxyurea antipurine agents: purinethol, thioguanine,
-24-5

pentostatin, cladribine, cytotoxic nucleoside synthesis
inducers: gemcitabine,
[0057] v) a compound chosen from the other groups of
tubulin-affinity agents, vinca alkaloids which disrupt the
mitotic spindle: vincristine, vinblastine, vindesine,
navelbine, agents which block the depolymerization of the
mitotic spindle: paclitaxel, docetaxel,
agents which induce DNA cleavage by inhibition of topoisomerase
II: etoposide, teniposide,
topoisomerase I inhibitors which induce DNA cleavage:
topotecan, irinotecan,
[0058] vi) a DNA splitting or fragmenting agent, such as
bleomycin,
[0059] vii) one of the following compounds: plicamycin, L-
asparaginase, mitoguazone, dacarbazine,
[0060] viii) an anticancer progestative steroid; medroxy-
progesterone, megestrol,
[0061] ix) an anticancer estrogen steroid:
diethylstilbestrol; tetrasodium fosfestrol,
[0062] x) an antiestrogen agent: tamoxifen, droloxifen,
raloxifen, aminoglutethimide,
[0063] xi) a steroidal antiandrogenic agent (eg cyproterone)
or a non-steroidal antiandrogenic agent (flutamide,
nilutamide).
[0064] In addition to the API's mentioned herein, the dosage
forms of the invention can, in addition or instead, include
vitamins, minerals and dietary supplements. As used in this
disclosure, the term "vitamin" refers to trace organic
substances that are required in the diet. For the purposes of
the present invention, the term "vitamin(s)" includes, without
limitation, thiamine, riboflavin, nicotinic acid, pantothenic
acid, pyridoxine, biotin, folic acid, vitamin B.sub.12, lipoic
acid, ascorbic acid, vitamin A, vitamin D, vitamin E and
vitamin K. Also included within the term "vitamin" are the
-25-
26

coenzymes thereof. Coenzymes are specific chemical forms of
vitamins. Coenzymes include thiamine pyrophosphates (TPP),
flavin mononucleotide (FMM), flavin adenine dinucleotide (FAD),
Nicotinamide adenine dinucleotide (NAD), Nicotinamide adenine
dinucleotide phosphate (NADP), Coenzyme A (CoA), pyridoxal
phosphate, biocytin, tetrahydrofolic acid, coenzyme B.sub.12,
lipoyllysine, 11-cis-retinal, and 1,25-
dihydroxycholecalciferol. The term "vitamin(s)" also includes
choline, carnitine, and alpha, beta, and gamma carotenes.
[0065] The term "mineral" refers to inorganic substances,
metals, and the like required in the human diet. Thus, the term
"mineral" as used herein includes, without limitation, calcium,
(calcium carbonate), iron, zinc, selenium, copper, iodine,
magnesium, phosphorus, chromium and the like, and mixtures
thereof. The term "dietary supplement" as used herein means a
substance which has an appreciable nutritional effect when
administered in small amounts. Dietary supplements include,
without limitation, such ingredients as bee pollen, bran, wheat
germ, kelp, cod liver oil, ginseng, and fish oils, amino-acids,
proteins and mixtures thereof. As will be appreciated, dietary
supplements may incorporate vitamins and minerals.
[0066] In general, the amount of active ingredient
incorporated in each tablet or dosage form (API, vitamin,
mineral, dietary supplement and the like), may be selected
according to known principles of pharmacy. An effective amount
of API is specifically contemplated. By the term "effective
amount," it is understood that, with respect, to for example, a
"pharmaceutically effective amount" is contemplated. A
"pharmaceutically effective amount" is the amount or quantity
of a drug or API which is sufficient to elicit the required or
desired therapeutic response, or in other words, the amount
which is sufficient to elicit an appreciable biological
response when administered to a patient. As used with reference
to a vitamin or mineral, the term "effective amount" means an
-26-
27

amount at least about 10% of the United States Recommended
Daily Allowance ("RDA") of that particular ingredient for a
patient. For example, if an intended ingredient is vitamin C,
then an effective amount of vitamin C would include an amount
of vitamin C sufficient to provide 10% or more of the RDA.
Typically, where the tablet includes a mineral or vitamin, it
will incorporate higher amounts, preferably about 100% or more
of the applicable RDA.
[0067] The amount of active ingredient used can vary
greatly. Of course, the size of the dosage form, the
requirements of other ingredients, and the number of, for
example, tablets which constitute a single dose will all impact
the upper limit on the amount of pharmacologically active
ingredient which can be used. However, generally, the active
ingredient is provided in an amount of between greater than
zero and about 80% by weight of the finished tablet and, more
preferably, in a range of between greater than zero and about
60% by weight thereof. Put in other terms, the active
ingredient can be included in an amount of between about 1
microgram to about 2 grams, and more preferably between about
0.01 and about 1000 milligrams per dosage form, i.e., per
tablet.
[0068] Although the invention herein has been described with
reference to particular embodiments, it is to be understood
that these embodiments are merely illustrative of the
principles and applications of the present invention. It is
therefore to be understood that numerous modifications may be
made to the illustrative embodiments and that other
arrangements may be devised without departing from the spirit
and scope of the present invention as defined by the appended
claims.
INDUSTRIAL APPLICABILITY
[0069] The present invention enjoys wide industrial
applicability including, but not limited to, providing
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28

packaging for medications, especially those in tablet form and
frangible tablet form.
-28-

We claim:
1. A blister package comprising:
a unitary blister sheet defining at least one unit
package region, the at least one unit package region including
a recess having an open top and a flange surrounding the
recess; and
a unitary sheet of lidding material peelably sealed
to the flanges,
wherein said blister sheet and said sheet of lidding
material further define unsealed areas for facilitating
peeling of said lidding material from said blister sheet, said
unsealed areas being accessible by a user upon the bending of
at least a portion of said blister sheet and said sheet of
lidding material.
2. The blister package according to claim 1, wherein
said blister sheet includes four unit package regions.
3. The blister package according to claim 2, wherein
each unit package region is removable from said blister
package.
4. The blister package according to claim 3, further
including lines of weakness, wherein each unit package region
is defined by the lines of weakness.
5. The blister package according to claim 1, wherein
said sheet of lidding material further includes perforations
for accessing the unsealed areas.
6. The blister package according to claim 1, wherein
the recess includes walls and a closed bottom.
7. The blister package according to claim 6, wherein a
dosage form may be disposed in the recess so that the walls
hold the dosage form away from the closed bottom and adjacent
said lidding material so that there is an empty space between
each dosage form and the closed bottom of the recess.
-29-
8. A packaged dosage form including a package as
claimed in claim 1 and a plurality of pharmaceutical dosage
forms disposed in the recesses.
9. The packaged dosage form claimed in claim 8, wherein
the pharmaceutical dosage forms are fentanyl.
10. A method of removing a dosage form from a blister
package comprising:
providing said blister package having a blister
sheet and a sheet of lidding material, wherein the blister
sheet and the sheet of lidding material define at least one
unit package region including at least one recess and at least
one inaccessible unsealed area;
bending at least a portion of said blister package
to allow access of the unsealed area;
grasping at least a portion of the unsealed area;
pealing away at least a portion of the lidding
material to reveal at least one dosage form disposed in the
recess; and
removing the at least one dosage form.
11. The method according to claim 10, further comprising
the step of separating at least one unit package region from
other unit package regions.
12. The method according to claim 10, wherein said
bending step includes splitting a portion of the lidding
material along a line of perforations.
13. A blister package comprising:
a blister sheet including at least one recess having
an open top and a flange surrounding the recess; and
a sheet of lidding material including perforations,
said sheet of lidding material peelably sealed to at least a
31

portion of the flanges and defining at least one unsealed area
between said blister sheet and said sheet of lidding material,
wherein the perforations are located along at least
a portion of the at least one unsealed area and bending of
said blister package allows for splitting of the perforations
and access of the at least one unsealed area.
14. The blister package according to claim 13, wherein
said blister sheet includes a plurality of unit package
regions, each unit package region including at least one
recess and at least one flange surrounding the at least one
recess.
15. The blister package according to claim 13, wherein
the at least one recess includes walls and a closed bottom.
16. The blister package according to claim 15, wherein a
dosage form may be disposed in the recess so that the walls
hold the dosage form away from the closed bottom and adjacent
said lidding material so that there is an empty space between
each dosage form and the closed bottom of the recess.
Dated this 10th day of August, 2007.

(Kshitij Saxena)
of Amarchand & Mangaldas &
SureshA. Shroff & Co.
Attorneys for the Applicant
CIMA LABS INC.
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A blister package (10) and method of removing a dosage form (1) from a blister package
(10) are disclosed. In one embodiment, the blister package (10) includes a unitary blister
sheet (12) and a unitary sheet of lidding material (14). The lidding sheet (14) is peelably
sealed to the blister sheet (12), and includes unsealed areas (28) for facilitating the
peeling of the lidding material (14) from the blister sheet (12). The unsealed areas (28)
are preferably only accessible upon a bending of the blister package (10).

Documents:

http://ipindiaonline.gov.in/patentsearch/GrantedSearch/viewdoc.aspx?id=s4d08AydlrBSN2yoaQVV5w==&loc=wDBSZCsAt7zoiVrqcFJsRw==

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Patent Number

279510

Indian Patent Application Number

2930/KOLNP/2007

PG Journal Number

04/2017

Publication Date

27-Jan-2017

Grant Date

24-Jan-2017

Date of Filing

10-Aug-2007

Name of Patentee

CIMA LABS INC.

Applicant Address

10000 VALLEY VIEW ROAD EDEN PRAIRIE MINNESOTA

Inventors:

#	Inventor's Name	Inventor's Address
1	NIVALA, MICHELLE	5917 BAYBERRY DRIVE ST. PAUL, MINNESOTA 55110

PCT International Classification Number

B65D 83/04

PCT International Application Number

PCT/US2006/001189

PCT International Filing date

2006-01-12

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	60/644,393	2005-01-14	U.S.A.