Title of Invention	DRY POWDER INHALER DEVICE WITH PUSH BUTTON
Abstract	Dispensing device for precise and uniform administration of powdered medicament to a patient with easy to operate mechanism.

Full Text

FORM 2 THE PATENT ACT 1970 (39 of 1970)&The Patents Rules, 2003 COMPLETE SPECIFICATION (See section 10 and rule 13) 1. TITLE OF THE INVENTION: "Dispensing device for precise delivery of medicament" 2. APPLICANT (S) (a) NAME: Mecleods Pharmaceuticals Limited (b)NATIONALITY: Indian Company incorporated under the Indian Companies ACT, 1956 (c) ADDRESS: 3rd Floor, Church Road, Near Leela Hotel, Andheri (East), Mumbai - 400 059, Maharashtra, India 3. PREAMBLE TO THE DESCRIPTION: The following specification particularly describes the invention and the manner in which it is to be performed. Technical Field of the Invention: The present invention relates to a dispensing device, more particularly, to a dry powdered medicament inhaler device for precise and uniform dispensing of a powdered medicament placed in the aspiration chamber for inhalation by a patient, preferably by mouth. Description and Prior art of the Invention: Inhalers are widely and commonly used to administer medicaments into a patient's lungs. Typically, an inhaler comprises dispersion chamber containing a mixture of medicament particles and air or propellant gas. The mixture is dispensed via the patient inhaling from a mouthpiece on the inhaler with the air or propellant gas carrying the medicament particles into the patient's lungs. Generally, inhaler devices are divided into three categories used to administer and deliver medicament via aerosol-based inhalation. The most common is the pressurized metered dose inhaler (MDI) using ozone-depleting CFC propellant such as from. Pressurized metered dose inhalers (MDIs) require correct co-ordination and good timing between activation and inhalation which make them difficult to operate. Second is use of nebulizers by generating aerosol vapour of medicament. In operation, nebulizers deliver droplets in a size range that enables the medicament to reach the periphery of lung through the air passage of a patient. However, due to small droplets the time required to deliver a clinically significant dose is relatively long. The third category of inhaler is a dry powder inhaler (DPI), which is more preferred alternative to MDI for dispensing or delivering medicaments into patient's lungs for systemic and localized effects. Typically, in dry powder inhalers (DPIs), the medicament particles, in the form of a fine dry powder, are entrained into airflow, and inhaled by the patient. DPI offers various advantages as compared to other categories of inhalers such as they are environmental friendly (no use of propellants), offer better product stability, and automatic co-ordination between activation and inhalation. Generally, known DPI devices use either individual pre-measured doses, such as capsules containing the drug, which can be inserted into the device prior to dispensing 2 or bulk powder reservoirs which are configured to administer successive quantities of the drug to the patient via a dispensing chamber which dispenses the precise dose. Conventionally, DPIs have operated passively, relying on the inspiratory effort of the patient to dispense the drug provided by the powder. Unfortunately, this passive operation can lead to poor dosing uniformity since inspiratory capabilities can vary from patient to patient. In operation, particularly of DPI devices, it is desired that a uniform dispersion amount and desired physical form of the dry powder be dispersed into a patient's lungs and directed to the desired deposit site. If the patient is unable to provide sufficient respiratory effort, the extent of drug penetration, especially to the lower portion of the airway, may be impeded. This may result in premature deposit of the powder in the patient's mouth or throat. Some inhalation devices have attempted to resolve problems attendant with conventional passive inhalers involving various techniques. Some of these techniques use the airflow from the patient's inspiration alone to disperse the medicament. Other techniques involve piercing or incision of the capsule by pressing sharp pins or blades. However, these devices are having drawbacks associated during inhalation, resulting into administration of non-uniform dose of medicament due to loss/adhesion of medicament to the surface and presence of obstruction inside the dispersion chamber. Accordingly, there is a need for an improved dry powder inhaler for efficiently providing uniform and precise dose to the patient. Objective of the Invention: It is therefore an object of the present invention to devise a dry powder inhaler device which resolves the shortcomings of the prior art devices and provides uniform and precise dose to the patient effectively. The structure is simple and reliable, can be operated with ease by the patient. It is another object of the present invention to provide a dry powder inhaler device which can administer or deliver more uniform dose of medicament with easy to operate mechanism. 3 It is another object of the present invention to provide a dry powder inhaler device designed to have unobstructed activity inside the aspiration chamber. It is an additional object of the present invention to provide a dry powder inhaler device designed to avoid any adhesion of medicament with the inner or bottom surface of the aspiration chamber. It is yet another object of the present invention to provide a dry powder inhaler device designed to administer uniform dose of medicament with less inspiratory effort from the patient by shortening the distance between the aspiration chamber containing the powdered medicament and mouthpiece outlet opening towards the mouth of the patient. It is the further object of the present invention to provide a dry powder inhaler device designed to have uniform turbulence of airflow inside the aspiration chamber for effective and uniform delivery of medication to the patient's lungs. To achieve the foregoing and other objectives, a dry powder inhaler device is provided. Summary of the Invention: The present invention relates to a dry powder inhaler device for effective and uniform dispensing of a powdered medicament placed in the aspiration chamber for oral inhalation by a patient. In one aspect of the invention, a dry powder inhaler device has an aspiration chamber which can be rotated in both the direction coupled with pressing knob configured on the external circumference of the aspiration chamber. The aspiration chamber is a confined area with an inlet aperture in the side wall wherein the dry powder medicament is dispersed and/or mixed with the air entering tangentially through the said aperture. There can be optionally one more inlet aperture in the said wall of the aspiration chamber. The pressing knob is further mechanically coupled with a spring for smooth functioning of knob pressing action. 4 In another aspect of the invention, a dry powder inhaler device has a tapering circular designed mouthpiece having a holding aperture for holding capsule-shaped medicament with one outlet opening attached into the aspiration chamber wherein the said outlet opening is further having filter for de-agglomeration of the medicament particles. In yet another aspect of the invention, a removable bottom plate is attached to the said aspiration chamber. The bottom plate facilitates the cleaning of the dry powder inhaler device. These and other aspects of the present invention will become apparent from the following detailed description of the preferred embodiments and by the accompanying drawing. Brief Description of the drawings: A complete understanding of the present invention may be obtained by reference to the accompanying drawing, when considered in conjunction with the subsequent detailed description, in which: FIGURE 1 is a side view of complete inhaler device wherein 1 is a mouthpiece 2 is a filter 3 is a pressing knob 4 is a spring 5 is an aspiration chamber 6 is a bottom plate 7 is a medicament 8 is a circumferential wall 9 is an open central area 11 is an outlet opening 12 is a channel 13 is a holding aperture 14 are perforations. 5 FIGURE 2 is yet another side view of complete inhaler device wherein 1 is mouthpiece 3 is pressing knob 6 is bottom plate 9 is open central area 10 is inlet aperture Detailed Description of the Preferred Embodiments: Turning now in to the details of the preferred embodiments as shown in FIG. 1, an inhaler device has a mouthpiece (1) attached to an aspiration chamber or capsule well (5). The term mouthpiece herein means a nose/mouthpiece, i.e. a component adapted to be placed directly or indirectly on, in, over, or against a patient nose or mouth or both. The mouthpiece is made of plastic polyvinyl chloride, non-plastic polyvinyl chloride, polyolefines, polyethylene, polypropylene, polyethylene-vinyl acetate, silicone, polyethylene terephthalate and such like. The mouthpiece (1) is having a holding aperture (13) for holding capsule-shaped medicament (7) with outlet opening (11) attached into the aspiration chamber (5) wherein the said outlet opening is further having filter (2) for de-agglomeration of the medicament particles. The mouthpiece (1) is generally sized and shaped to fit over the aspiration chamber (5). The filter (2) is having plurality of perforations (14). In a preferred embodiment of the claimed invention, the inner circumference of mouthpiece is about 13 millimeters in diameter and outer circumference is about 16 millimeters in diameter. The height of mouthpiece is about 28 millimeters. The aspiration chamber (5) includes a pressing knob or a capsule cutter (3) and a circumferential wall (8). The pressing knob (3) is configured on the external circumferential wall (8) of the aspiration chamber (5). An inlet aperture (10) is made in the circumferential wall (8) for facilitating air to enter tangentially inside the aspiration chamber (5). The circumferential wall is a round and smoothly curved surface. The mouthpiece (1) is attached vertically to the aspiration chamber (5), guiding towards an open central area (9). The aspiration chamber (5) is made of plastic polyvinyl chloride, non-plastic polyvinyl chloride, polyolefines, polyethylene, polypropylene, polyethylene-vinyl acetate, silicone, polyethylene terephthalate and 6 such like. The aspiration chamber (5), may also be integrally molded or manufactured. In a preferred embodiment of the claimed invention, the inner circumference of chamber (5) is about 27 millimeters in diameter and outer circumference is about 41 millimeter in diameter, having a height of about 23 millimeters. The chamber (5) can be rotated in both the directions. The pressing knob (3) is made of rigid or semi-rigid material and can be variable shape and size. The knob (3) is pressed into the chamber (5) through a channel (12) for breaking the dose of medicament (7) and is restored back to its original position leaving open central area (9) unobstructed. The knob (3) is coupled with a mechanical spring (4). The bottom plate (6) is attached to the said aspiration chamber (5). The bottom plate (6) can be removed to facilitate cleaning of the inhaler device and generally sized and shaped to fit under the aspiration chamber (5). In a preferred embodiment the length of the inhaler device is about 54.5 millimeter. Length of the inhaler device allows patient to inhale uniform dose of medicament with minimum efforts and to reach the preferred location. Capsule containing medicament is placed in holding aperture (13). The knob (3) is pressed and the mouthpiece (1) along with the chamber (5) is simultaneously rotated in opposite direction to break the capsule containing medicament. The broken medicament falls in the chamber (5) and the knob is released, restoring the open central area (9) unobstructed. When the patient inhales through the mouthpiece (1) of the inhaler device, airflow enters tangentially through the inlet aperture (10) creating a uniform turbulence or cyclone inside the aspiration chamber (5) and dispersing the medicament into small particles which is further carried along with air stream into the patient's lungs. The uniform turbulence inside the chamber (5) avoids any adhesion of medicament with the inner or bottom surface of the dispersion chamber thus preventing loss of medicament and administering uniform and precise dose of medicament to the patient. 7 Various changes and modifications may of course be made without departing from the spirit and scope of the invention. The invention, therefore, should not be limited, except by the following claims and their equivalents. 8 We claim, 1. An inhaler device for dispensing powdered medicament for oral inhalation by a patient with minimum inspiratory efforts comprising: a) an aspiration chamber having an inlet aperture in the side wall of the said chamber; b) a pressing knob wherein the said knob is configured on the external circumference of the said chamber; c) a tapering circular shaped mouthpiece having an aperture for holding a dose of medicament wherein one outlet opening of the said mouthpiece is attached into the said chamber; and d) a bottom plate attached to the said chamber. 2. The device of claim 1, wherein the said aspiration chamber is rotated in both the directions. 3. The device of claim 1, wherein the said knob acts as an obstruction when pressed into the said chamber by the patient, which is restored back to its original position after pressure is released from the knob. 4. The device of claim 1, wherein a two piece gelatin capsule containing dose of medicament inserted into the said aperture breaks open when the said knob is in pressed condition and the aspiration chamber is rotated. 5. The device of claim 1, wherein the said knob is coupled with a mechanical spring. 6. The device of claim 1, wherein the air is entered tangentially through the said aperture, creating a cyclone inside the said chamber. 7. The device of claim 1, wherein the said outlet opening is provided with a filter for de-agglomeration of the medication particles. 8. The device of claim 6, wherein the said filter is designed to have plurality of perforations. 9 9. The device of claim 1, wherein the said bottom plate is optionally removable. 10. The device of claim 1, wherein the said device is made of plastic polyvinyl chloride, non-plastic polyvinyl chloride, polyolefines, polyethylene, polypropylene, polyethylene-vinyl acetate, silicone, polyethylene terephthalate and such like. Dated this 19th day of January 2006 Dr. Gopakumar G. Nair Agent for the Applicant 10 Abstract: Dispensing device for precise and uniform administration of powdered medicament to a patient with easy to operate mechanism. 11

Documents:

94-mum-2006-abstract(21-03-2007).doc

94-mum-2006-abstract(21-03-2007).pdf

94-mum-2006-abstract.doc

94-mum-2006-abstract.pdf

94-mum-2006-cancelled pages(12-07-2007).pdf

94-mum-2006-claims(granted)-(12-07-2007).doc

94-mum-2006-claims(granted)-(12-07-2007).pdf

94-mum-2006-claims.doc

94-mum-2006-claims.pdf

94-mum-2006-correspondence(12-07-2007).pdf

94-mum-2006-correspondence(ipo)-(07-06-2007).pdf

94-mum-2006-correspondence-received.pdf

94-mum-2006-descripiton (complete).pdf

94-mum-2006-drawing(12-07-2007).pdf

94-mum-2006-drawings.pdf

94-mum-2006-form 1(19-01-2006).pdf

94-mum-2006-form 1(21-03-2007).pdf

94-mum-2006-form 1(25-01-2007).pdf

94-mum-2006-form 18(07-03-2006).pdf

94-mum-2006-form 2(granted)-(12-07-2007).doc

94-mum-2006-form 2(granted)-(12-07-2007).pdf

94-mum-2006-form 26(13-05-2005).pdf

94-mum-2006-form 3(18-01-2006).pdf

94-mum-2006-form 9(24-01-2006).pdf

94-mum-2006-form-1.pdf

94-mum-2006-form-18.pdf

94-mum-2006-form-2.doc

94-mum-2006-form-2.pdf

94-mum-2006-form-26.pdf

94-mum-2006-form-3.pdf

94-mum-2006-form-9.pdf

94-mum-2006-granted.pdf

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