Title of Invention	A PROCESS FOR PREPARING A COMPOSITION FOR MANUFACTURING TEXTURED SOLUBLE CONTAINER AND A CONTAINER MANUFACTURED THEREFROM
Abstract	The invention discloses a process for preparing a composition for manufacturing textured soluble cantainer comprising mixing a texturing agent having a substantial amount of Liquorice with or without plasticizers or other additives into gelatin solution. The solution is than molded into containers by dip molding process.

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 of 1970) COMPLETE SPECIFICATION [See section 10] A PROCESS FOR PREPARING A COMPOSITION FOR MANUFACTURING TEXTURED SOLUBLE CONTAINER AND A CONTAINER MANUFACTURED HERE FORM. SCITECH CENTRE, A COMPANY INCORPORATED UNDER SECTION 25 OF THE COMPANIES ACT, 1956, WHOSE ADDRESS IS 7, PRABHAT NAGAR, JOGESHWARI (WEST), MUMBAI - 400 102, MAHARASHTRA, INDIA; THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES AND r.u._ ~t ASCERTAINS THE NATURE OF THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFOMEt FIELD OF THE INVENTION The present invention relates to an improved composition, for manufacturing textured soluble container eg. Capsule with roughened surface and low inter-capsule agglomeration, and an improved process for manufacturing textured soluble container therefrom. Gelatin or cellulose derivatives are widely used as the base material for manufacture of capsules and films for packaging of diverse products in the drugs/pharmaceutical, cosmoceutical, nutraceutical, foods and agrochemical industry. BACKGROUND ART The process of preparation of the composition and thereafter manufacture of such gelatin containers generally involve the following steps: Gelatin solution is prepared by using dry gelatin and demineralised water. The mixture is heated to solubilise the gelatin. Preservatives may be added at this stage. The clear transparent gelatin solution is obtained by filtering and colorants, opacifiers and surfactants are added in the solution. The required viscosity is adjusted by adding DM water. This solution is warmed, de-aerated and transferred to the gelatin dip tanks. Stainless steel capsule molding pins are dipped into the gelatin solution and withdrawn to form cap and body in separate operations. The pins are rotated to distribute the geiatin uniformly. During this time the gelatin is set or gelled by a blast of cold air. The pins are moved through a series of controlled air drying kilns for removal of water. After drying the capsules are stripped from the pins and trimmed to length. After trimming the cap and body sections are joined and ejected from the machine. In the case of gelatin based soluble containers especially capsules generally contain moisture in the range from 10-17% at the end of the drying process. Lowering the moisture of gelatin capsules results in the loss of elasticity and development of brittleness. Furthermore gelatin capsules are sensitive to heat and humidity, which significantly affects the usability of the product. In particular soft gelatin capsules are known to aggregate under hot and humid conditions of storage and transport. Gelatin capsules by their very nature are prone to acquire static charge at low Relative humidity. Under dry conditions gelatin films may induce static charge build up affecting later processing. The static charge on empty capsules hampers smooth flow of empty capsules on capsule filling machines. This problem is generally overcome by using static charge eliminator on empty capsule sorting machine prior to filing. Alternatively, it can also be reduced by applying a small quantity of talcum powder or dried starch to empty capsules prior to their loading in the capsule-filing machine. Before packing of empty capsules, any static charge that is generated is eliminated by using static charge eliminators at the discharge end of capsule counting machine. The packing material is generally selected so that they do not generate static charge on capsules during transportation. The use of water-soluble film forming cellulose derivatives as substitute of gelatin is widely known in literature. European Patent document EP0714656 suggests the use of low viscosity (2.4 to 5.4 centistokes) hydroxypropylmethylcellulose (HPMC) with carrageenan as gelling agent and calcium or potassium as co-gelling agent to produce capsules with lower water contents. However, it has been found that lower molecular weight chains induce high film brittleness. Published patent document WO 98/27151 discloses polymer compositions for film forming particularly hard and soft capsules comprising of water - soluble ethers, hydrocolloids and sequestering agents. These compositions resulted in capsules with lower water content and improved elasticity. OBJECTS OF THE INVENTION An object of this invention is to provide a means of creating textured roughened surfaced soluble containers, specifically in the case of gelatin based containers such as capsules by incorporation of texturing agents to obtain capsules with normal water content but with low stickiness and low static charges. An object of the present invention is to provide textured containers such as capsules with low stickiness that: can be packed and transported in normal poly-bags without the need to pack them into special poly-bags to avoid problems due to static charge effects of / non-textured capsules. Another object of the present invention is to provide textured capsules with lower static charges with enhanced flow properties as compared to the regular glossy gelatin capsule with high static charges. Another object of the present invention is to provide a textured surface of the cap and the body of the capsules to ensure a good fit so that they do not separate during transportation under varied climatic or environmental conditions. Yet another object of the invention is to provide textured surface of the capsules and containers to enable better coating of the same as compared to normal gelatin capsules whose glossy and smooth surface gives problems during coating because the film forming polymers do not easily adhere to the smooth regular capsule surface. Yet another object of the present invention is to produce herb embedded gelatin capsules so as to segregate specific sensitive herbs from the herbal formulations that may be non-compatible with other ingredients of the formulation. Yet another object of the present invention is to provide capsules with a look and feel of herbal-based products as is desired by consumers. Yet another object of the present is to provide a textured soluble container whereby reduction in brittleness is obtained by addition of natural or synthetic plasticizers. Thus according to an aspect of the present invention the same provides herbal textured containers / packs such as capsules and the like for containing products such as drugs / pharmaceuticals, cosmoceutical, neutraceutical and food wherein at least a portion of the external surface of the said container/pack/capsule is textured with herbal content/finish. In accordance with a preferred aspect, the said textured surface finish of herbal content is provided for the whole of the container / capsule body. Preferably the basic container / capsules body is made of conventional capsule material such as gelatin, cellulose derivatives or any other material along with the texturing agent to provide a textured finish on the capsule surface. Importantly, such herbal textured containers such as capsules and the like would have lower static charges and favour enhanced flow properties required in capsule manufacture. Also, such textured finish on capsules provide for better surface finish and coating of the capsules and/or have advantages in terms of feel and look of herbal capsules. SUMMARY According to the present invention, a process for preparation of the composition for manufacture of textured soluble containers / packs / capsules for drug / pharmaceutical, neutraceutical, cosmoceutical, agrochemical contents, etc. and thereafter manufacturing the said container comprises the steps of: (a) selecting the herbal texturing agent containing a substantial amount of Liquorice and providing the same in desired form; (b) providing the gelatin solution with or without additives in substantially clean form in container / tanks. (c) Adding the texturing agent in said tank; (d) deaeration of the solution and providing the same in dipping tank; (e) dipping the capsule making pin moulds in the solution followed by withdrawing and subjecting the same to drying DETAILED DESCRIPTION OF THE INVENTION According to the present invention, a process for preparing the composition for manufacturing textured soluble containers / packs / capsules for drug / pharmaceutical contents and the like and the process for manufacture of the said container comprising: (a) selecting the herbal texturing agent containing a substantial amount of Liquorice, and providing the same in desired form preferably as powder; (b) providing the gelatin solution with or without additives in substantially clean form in container / tanks; (c) Adding the said texturing agent in said tank; (d) deaeration of the solution and providing the same in dipping tank; (e) dipping the capsule making pin moulds in the solution followed by withdrawing and subjecting the same to drying. The term gelatin has been used herein for the purposes of illustration only. Other compositions such as cellulose derivatives, starch, gums, polyvinyl alcohol, etc., may also be used instead of gelatin. In accordance with a preferred aspect of the present invention, the process of manufacture of textured capsules involves the following steps; i. Selection of the herbal texturing agent containing a substantial amount of Liquorice in appropriate form wherein the texture forming dried herbal material is cut into appropriate small sizes and shapes, or they may be used in the commercially available form sorted out in specified particle size range from 5 microns to 300 microns. ii. Addition level of sterilized herbal powder of about 0.5 % w/w to about 10% w/w preferably between 1 to 2 % w/w wherein the herbal powder is sterilized by any method known in the art such as autoclaving prior to its use; iii. Making of gelatin solution of from 25% to 40% w/v in water; iv. Addition of preservatives at this stage to the resultant solution of step (iii); v. Heating of the resultant product of step (iv) with stirring to melt the gelatin to form a transparent solution wherein this solution is filtered to remove any extraneous matter and transferred to the gelatin holding tanks; vi. Addition of the pulverized and sterilized texturing agent to the gelatin solution in the molding tank as such or in slurry form to prevent any lump formation wherein stirring for not less than 5 minutes is done to prevent any lumping and the gelatin solution temperature is maintained in the range of about 40 deg. C to about 65 deg, C, preferably 45 to 55 deg.C; vii. Incorporation of colourant or opacifier such as titanium dioxide from 0.1 % to 5 % preferably from 0.5 to 1 % w/w; viii. Adjustment of the viscosity of the gelatin solution by addition of desired quantity of warm water; ix. Addition of natural or synthetic placticizer in the gelatin solution may be necessary under some conditions; x. Deaerating the solution prior to taking it for capsule formation; xi. Transferring of the solution to the "cap and body" dipping tank wherein the temperature of the dipping tank is maintained from 45 deg. C to 55 deg. C preferably from 46 to 52 deg. C; xii. Dipping of the capsule - making pin moulds into the gelatin solution and the pins are then withdrawn, turned and pushed inside the drying zone and the capsule pins with gelatin on it travel through a drying zone of temperature about 22 deg. C to about 30 deg. C preferably between 24 deg. C to 28 deg. C during this time the gelatin is set on the pins and dried; xiii. Mechanical removal of the capsules from the pins; xiv. The resultant capsules are cut into required length mechanically, joined cap and body and kept for aeration at 20 deg. C to 30 deg. C, preferably 24 deg. C to 28 deg. C for 60 minutes to 200 minutes; The moisture content of the capsules is usually maintained between 12% to 20% w/w and most commonly between 15% to 18% w/w; The texturing material may include powders of any fibrous root or stem selected from the plant genus Asparagus, Angelica, Argyreia, I Anisum, Azadiracta, Acacia, Acorus, Andrographis, Berberis, Bergenia, Boerhaavia, Curcuma, Cuminum, Cinnamomum, Coriandrum, Centella, Clerodendrum, Dioscorea, Echinacea, Eclipta, Foeniculum, Gingiber, Gymnema, Hemidesmus, Hydrastis, Nardostachys, Pueraria, Phyllanthus, Picrorrhiza, Pluchea, Ricinus, Rauwolfia, Rubia, Sida, Saraca, Saussuria, Terminalia, Tinospora, Tylophora, Valeriana, Withania and the like. The particle sizes of the texturing powder are in the mesh size range of about BSS sieve #20 to #200, preferably BSS sieve #70 to #80 for the purposes of the application disclosed in this invention. This invention will now be described in detail with the help of the drawings accompanying this specification wherein FIG 1 (a) is a photograph of untextured capsules in lumped form. FIG 1 (b) is a photograph of textured capsules illustrating free flow nature and no lump formation. FIG 2 (a) is a photograph of untextured capsules sticking to poly-bag. FIG 2 (b) is a photograph of textured capsules illustrating non-sticking nature of the capsules in the poly-bag. The invention may be better understood by the reference to the following examples which are intended for the purpose of illustration and are not to be construed as, in any way limiting the scope of the present invention, which is defined in the claims appended hereto. EXAMPLE 1 10 g of distilled water was added to 5 g. of commercially available I Asparagus racemosus root powder followed by solution of 10 g.of distilled water and 10 g. glycerine. This was then kept on a water bath at 45 deg.C for two hours. In another beakers 500 g. gelatin solution (33.3 % w/v) was taken. Contents of the first beaker was added in the gelatin solution and stirred well. The entire mass was de-aerated at 50 deg. for one hour. Capsule molding pins were hand dipped and dried in the capsule drying zone. After drying the capsules were removed from the pin to obtain the capsules with herbal texture. EXAMPLE 2 10 g. of Liquorice fine powder passed through # 70 sieve was dispersed in 500g gelatin solution (33.3% w/v.) 2.5 g of Titanium dioxide was mixed with 10 ml water and added to the gelatin solution. The suspension was stirred for 30 minutes to obtain a homogenous dispersion. The contents were deaerated at 50 deg. C for one hour and capsule molding pins were hand dipped followed by drying in the capsule drying zone. After drying the capsules were removed from the pin. EXAMPLE 3 :- Example 2 was repeated using transparent gelatin solution excluding the opacifier Titanium dioxide. It was observed that titanium dioxide was required to give the capsule shells the natural color and herbal texture. The capsule formed in the above manner demonstrates following properties:- 1. Capsule shell wall exhibit rough surface. The electron micrographs show that the herbal particles are dispersed with sizes varying from about 2 microns to about 250 microns. 2. The moisture content of the capsules was in the range from 14% w/w to 16% w/w after drying. 3. Disintegration time of the empty capsules varying from 3 to 6 minutes in water as per pharmacopoeial method. 4. Angle of repose is 32 deg. as against the regular gelatin capsule with 22 deg. This is of specific advantage in determining the flow characteristics in the capsule-manufacturing machine. Generally material having angle of repose between 20 to 40 show good flow of capsules on the machine. 5. Lump formation was checked compared to the regular gelatin capsules. Textured capsules and normal gelatin capsules were exposed to 40 deg. C. and 75% RH for 20 hours. The normal gelatin capsules stuck to each other and formed lumps whereas the textured capsules did not stick to each other preventing lump formation. This feature is illustrated in figure 1 of the accompanying drawings. 6. The stickiness of the capsules wall was compared to that of the un-textured gelatin capsules. The capsules were taken in two different polyethylene bags and shaken for 3 minutes. The un-textured capsules stick to the bag showing static on the walls compared to the textured capsules. This feature is illustrated in figure 2 of the accompanying drawings. 7. A process for preparing a composition for manufacturing a textured soluble container comprising: mixing texturing agent with particle size in the range of 5 microns to 300 microns and Liquorice with gelatin solution, optionally adding additives; heating the gelatin solution at the temperature in the range of 40 deg. C to 65 deg. C, preferably at 45 deg. C to 55 deg. C and stirring the solution. 8. The process according to claim 1 wherein the texturing agent is mixed after sterilization, to an amount equal to 0.5 weight percent to 10 weight percent, preferably between 1 weight percent to 2 weight percent, .in slurry form without any lump formation. 9. The process according to claim 1 wherein the gelatin solution is prepared to contain gelatin of about 25 - 40 percent weight per volume in water. 10. The process of claim 1 wherein the texturing agent is herbal texturing agent selected from the fibrous root or stem part of one or more plant genus Asparagus, Angelica, Anisum, Azadiracta, Acacia, Acorus, Andrographis, Berberis, Berginia, Boerhaavia, Curcuma, Cuminum, Cinnamonum, Coriandrum, Centella, Cleorodendrum, Dioscorea, Echinacea, Eclipta, Foeniculum, Gingiber, Gymnema, Hemidesmus, Hydrastis, Nardostachy, Pueraria, Phyllanthus, Picrorrhiza, Pluchea, Ricinus, Rauwolfia, Rubia, Sida, Saraca, Saussuria, Terminalia, Tinospora, Tylophora, Valeriana, Withania. 11. The process according to claim 1 wherein the gelatin solution is prepared to contain gelatin of about 25 - 40 percent weight per volume in water. 12. The process of claim 1 wherein the texturing agent is herbal texturing agent selected from the fibrous root or stem part of one or more plant genus Asparagus, Angelica, Anisum, Azadiracta, Acacia, Acorus, Andrographis, Berberis, Berginia, Boerhaavia, Curcuma, Cuminum, Cinnamonum, Coriandrum, Centella, Cleorodendrum, Dioscorea, Echinacea, Eclipta, Foeniculum, Gingiber, Gymnema, Hemidesmus, Hydrastis, Nardostachy, Pueraria, Phyllanthus, Picrorrhiza, Pluchea, Ricinus, Rauwolfia, Rubia, Sida, Saraca, Saussuria, Terminalia, Tinospora, Tylophora, Valeriana, Withania. 13. The process according to claim 1 wherein the additives comprise of colorants, opacifiers, preservatives, surfactants, preferably natural or synthetic plasticizers to reduce the textured container brittleness. 6. A process as claimed in claims 1-5 wherein the composition is further molded into a container, preferably a capsule. rth Dated this 5in day of September, 2001 FOR SCITECH CENTRE By their Agent

Documents:

849-mum-2001-assignment(07-06-2007).pdf

849-mum-2001-cancelled pages (26-10-2006).pdf

849-mum-2001-claims(granted)-(26-10-2006).doc

849-mum-2001-claims(granted)-(26-10-2006).pdf

849-mum-2001-correspondence(20-07-2007).pdf

849-mum-2001-correspondence(ipo)-(24-06-2008).pdf

849-mum-2001-drawing(03-10-2002).pdf

849-mum-2001-form 1(05-09-2001).pdf

849-mum-2001-form 1(06-02-2006).pdf

849-mum-2001-form 18(24-08-2005).pdf

849-mum-2001-form 2(granted)-(26-10-2006).doc

849-mum-2001-form 2(granted)-(26-10-2006).pdf

849-mum-2001-form 3(05-09-2001).pdf

849-mum-2001-form 4(03-09-2002).pdf

849-mum-2001-form 4(16-05-2006).pdf

849-mum-2001-form 5(06-02-2006).pdf

849-mum-2001-form 5(26-04-2006).pdf

849-mum-2001-general power of attorney(05-09-2001).pdf

849-mum-2001-general power of attorney(26-04-2006).pdf

849-mum-2001-petition under rule 137(27-04-2006).pdf

849-mum-2001-power of attorney(05-09-2001).pdf

849-mum-2001-power of authority(03-10-2002).pdf