Title of Invention	FAST DISSOLVING EMPTY HARD GELATIN CAPSULE SHELLS AND METHOD OF PRODUCING THE SAME
Abstract	The present invention provides a fast dissolving empty hard gelatin capsule shell comprising a combination of gelatin, surfactant, and an acidulant. The disntegration time of the capsule shell is less than 2 minutes. A method for preparing fast dissolving empty hard gelatin capsule shell is also provided

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 of 1970) COMPLETE SPECIFICATION [See section 10] FAST DISSOLVING EMPTY HARD GELATIN CAPSULE SHELLS AND METHOD OF PRODUCING THE SAME; 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 THE NATURE OF THIS INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED. TITLE : Fast dissolving empty hard gelatin capsule shells and method of producing the same FIELD OF INVENTION : The present invention relates to the field of soluble containers such as capsules for e.g. empty hard gelatin capsules which are used to carry materials such as pharmaceuticals, nutraceuticals, cosmeceuticals or agrochemicals. BACKGROUND ART: Capsules are elegant, easy to use, portable and tasteless shells for drugs. They are produced in a wide range of colors and capsules generally provide ready availability of the contained drug. Minimal excipient and little pressure are required to compact the material as is necessary in tabletting. In order to release the contents from the capsule, the capsule shell breaks and dissolves completely. Unless the shell dissolves completely the inside content will not be available in the solution for absorption. Dissolution is the process by which a solid based on its solubility enters into solution and becomes available for absorption by the body. Dissolution test has become a qualitative tool, which can provide valuable information about the biological availability of a drug as well as a batch to batch consistency. Dissolution is considered today as one of the most important quality control tests performed on pharmaceutical dosage forms. In determining the dissolution time and rate of drugs from solid dosage forms under standardised conditions, one has to consider several physicochemical characters of the dosage form. These include the wetting characteristics of the solid dosage forms, the penetration ability of the dissolution 2 medium into the dosage forms , the swelling process, disintegration and deaggregation. According to Carstensen's explanation, wetting of the solid dosage form surface controls the liquid access to the solid surface and many times is the limiting factor in the dissolution process. The rate of wetting is directly dependant upon the surface tension at the interface and upon the contact angle between the solid surface and the liquid. Generally a contact angle of more than 90 deg. indicates poor wettability. Incorporation of a surfactant either in formulation or dissolution medium lowers the contact angle and enhances dissolution. Capsule shells sometimes have long dissolution time because of higher disintegration time compared to tablets. SUMMARY OF THE INVENTION The present invention provides a fast dissolving empty hard gelatin capsule shell comprising Gelatin, surfactant, and acidulant wherein the dissolution of the capsule is less than two minutes. Particularly, the fast dissolving empty hard gelatin capsule of the present invention comprises gelatin, sodium lauryl sulphate, citric acid. The disintegration time of the capsule is less than 2 minutes and more particularly 1.5 minutes. Further, the present invention provides a method for preparing a fast dissolving empty hard gelatin capsule shell comprising the steps of: Preparing a slurry of surfactant and acidulant in water; Adding the slurry of surfactant and acidulant to gelatin solution at a predetermined temperature; Mixing and homogenizing the solution; Deaerating the solution to remove air bubbles; Dipping and molding into capsules by known dip molding method. DETAILED DESCRIPTION OF THE INVENTION: According to the present invention, the capsule shell dissolves faster compared to the regular gelatin capsules when wetting agents and surface-active agents are added into the capsule shell composition. The wetting agents and surface-active agents in the capsule shell makes the shell dissolve faster compared to the regular gelatin capsule shell. Thus faster disintegration and dissolution speeds up the content release from the shell. The standard conditions referred hereto according to the present invention includes a test apparatus as per disintegration assembly described in USP-24, physical tests (701) page; 1941. The assembly consists of six tubes. For testing the disintegration, one empty capsule was kept in each of the six tubes of the basket and operated the apparatus, using water maintained at 37 deg.C+/- 2 as the immersion fluid. The time required for first rupture was noted and the time required for complete dissolution of the shell was noted. The fast dissolving gelatin capsule shells of the present invention are prepared by preparing gelatin solution by conventional process. A slurry of surfactant and acidulant is prepared in water. This slurry is then homogenously mixed with the gelatin solution at 52 degree centigrade. The solution is then deaerated to remove air bubbles and taken to dip bath for molding capsules by dip molding method. The disintegration time of empty shells was found to be less than 2 minutes, more particularly 1.5 minutes. Gelatin is used in the range of 10 to 40% w/w, preferably 33% w/w. 4 The surfactant is selected from the group of sulphates, more particularly, sodium lauryl sulfate is used. The acidulant is selected from the group of weak acids more particularly citric acid is used. The fast dissolving gelatin capsule according to the invention shall include colorants, opacifiers, sweeteners, silicon dioxide, plasticizers, preservatives and the like. The invention can be well understood with the following examples but does not in any way limit the scope of the invention. Various disintegrants, surfactants and wetting agents were tried in the capsule shell and the disintegration time is compared with regular gelatin capsule. The experimental details are given below: Example 1 Gelatin solution (33% w/w) 100 g. Crosspovidone (disintegrant) 2 g. Water 25 ml Gelatin solution 33% w/w was prepared by a conventional process. The prepared gelatin solution was kept on water bath at 52 deg.C. and crosspovidone was added to 25 ml water and thereafter stirred well to make a slurry. The slurry was added to gelatin solution and stirred well till it was mixed homogeneously. The solution was deaerated to remove the air bubbles and taken to dip bath for molding capsules by dip molding method. Disintegration time of empty molded shells were found to be 3.5 mins. Example 2 Gelatin solution (33% w/w) 100 g. Citric acid 0.1 g. Sodium bicarbonate 2 g. Water 25 ml Gelatin solution 33% w/w was prepared by a conventional process The prepared gelatin solution was kept on water bath at 52 deg.C. Citric acid was dissolved in 5 ml water and this was added to gelatin solution and stired well till it is mixed homogeneously. Sodium bicarbonate is dissolved in rest of the water and gelatin solution is added and mixed well. The solution is deaerated to remove the air bubbles. This solution is into dip bath to mold capsules by dip molding method. Disintegration time of empty molded shells was found to be 2.8 mins. Example 3 Gelatin solution (33% w/w) 100 g. Sodium lauryl sulphate (surfactant) 1 g. Water 25 ml Gelatin solution 33% w/w was prepared by a conventional process The prepared gelatin solution was kept on water bath at 52 deg.C. Sodium lauryl sulphate was added to 25 ml water and stirred well to make a slurry. This slurry was added to gelatin solution and stirred well till it is mixed homogeneously. The solution was deareated to remove the air bubbles. This solution was taken to dip bath for molding capsules by dip molding method. Disintegration time of empty molded shells was found to be 2.5 mins. Example 4 Gelatin solution (33% w/w) 100 g. Silicon dioxide (anti-caking agent) 2 g. Water 25 ml Gelatin solution 33% w/w was prepared by a conventional process The prepared gelatin solution was kept on water bath at 52 deg.C. Silicon dioxide was added to 25 ml water and stirred well to make a slurry. This slurry was added to gelatin solution and stirred well till it is mixed homogeneously. The solution is deaerated to remove the air bubbles. This solution was taken to dip bath for molding capsules by dip molding method. Disintegration time of empty molded shells was found to be 2.5 mins. Example 5 Gelatin solution (33% w/w) 100 g. Starch amylum (disintegrant) 1 g. Silicon dioxide 1 g. Water 25 ml Gelatin solution 33% w/w was prepared by a conventional process The prepared gelatin solution was kept on water bath at 52 deg.C. Starch and silicon dioxide were added to 25 ml water and stirred well to make a slurry. This was slurry to gelatin solution and stirred well till it is mixed homogeneously. The solution was deaerated to remove the air bubbles. This solution was taken to dip bath for molding capsules by dip molding method. Disintegration time of empty molded shells was found to be 2 mins. Example 6 Gelatin solution (33% w/w) 100 g. Starch (amylum) 2 g. Water 25 ml Gelatin solution 33% w/w was prepared by a conventional process. The prepared gelatin solution was kept on water bath at 52 deg.C. Starch amylum was added 7 to 25 ml water and stirred well to make a slurry. This slurry was added to gelatin solution and stirred well till it is mixed homogeneously. The solution was deaerated to remove the air bubbles. This solution was taken to dip bath for molding capsules by dip molding method. Disintegration time of empty molded shells was found to be 1.5 mins. Example 7 Gelatin solution (33% w/w) 100 g. Maize starch (disintegrant) 3 g. Water 25 ml Gelatin solution 33% w/w was prepared by a conventional process. The prepared gelatin solution was kept on water bath at 52 deg.C Maize starch was added to 25 ml water and stirred well to make a slurry. This was slurry to gelatin solution and stirred well till it is mixed homogeneously. The solution was deareated to remove the air bubbles. This solution was taken to dip bath for molding capsules by dip molding method. Disintegration time of empty shells was found to be 5 mins. Example 8 Gelatin solution (33% w/w) 100 g. Sodium lauryl sulphate (surfactant) 1 g. Citric acid 0.5 g. Water 25 ml Gelatin solution 33% w/w was prepared by a conventional process. The prepared gelatin solution was kept on water bath at 52 deg.C Sodium lauryl sulphate and citric acid were added to 25 ml water and stirred well to make a slurry. This slurry 8 was added to gelatin solution and stirred well till it is mixed homogeneously. The solution was deaerated to remove the air bubbles. This solution was taken to dip bath for molding capsules by dip molding method. Disintegration time of empty shells was found to be 1.5 mins. Disintegration and complete dissolution of regular empty capsule shells according to the existing state of the art, are generally found to be more than 2 mins and sometimes 3-4 mins. The new empty capsule shells prepared according to the present invention disintegrates and dissolves completely within 1-2 mins. time. This enables faster dissolution and faster absorption of the drug. 9 WE CLAIM 1. A fast dissolving empty hard gelatin capsule shell comprising Gelatin, surfactant, and acidulant characterized in that the dissolution of the capsule is less than two minutes. 2. A fast dissolving empty hard gelatin capsule shell as claimed in claim 1 comprises gelatin, sodium lauryl sulphate, citric acid characterized in that the dissolution of the capsule is less than two minutes. 3. A fast dissolving empty hard gelatin capsule shell as claimed in any of the preceding claims wherein the disintegration time of the capsule is 1.5 minutes. 4. A method for preparing a fast dissolving empty hard gelatin capsule shell comprising the steps of: Preparing a slurry of surfactant and acidulant in water; Adding the slurry of surfactant and acidulant to gelatin solution at a predetermined temperature; Mixing and homogenizing the solution; Deaerating the solution to remove air bubbles; Dipping and molding into capsules by known dip molding method. 5. A method for preparing a fast dissolving empty hard gelatin capsule shell as claimed in claim 4 wherein the surfactant is selected from the group sulphates, preferably sodium lauryl sulphate is used. 6. A method for preparing fast dissolving empty hard gelatin capsule shell as claimed in any of the preceding claims wherein the acidulant is selected from the group weak acids, preferably citric acid is used. 10 7. A method of preparing fast dissolving empty hard gelatin capsule shell as claimed in any of the preceding claims wherein gelatin is in the range of 10 to 40% w/w. 8. A method of preparing fast dissolving empty hard gelatin capsule shell as claimed in any of the preceding claims wherein sodium lauryl sulphate is in the range of 0.1 to 10 % w/w 9.A method of preparing fast dissolving empty hard gelatin capsule shell as claimed in any of the preceding claims wherein citric acid is in the range of 0.1 to 2% w/w. 10.A method as claimed in any of the preceding claims wherein the predetermined temperature for adding slurry to gelatin solution is 20 to 70 deg. C, more particularly 52 degree Celsius. 11.A method of preparing fast dissolving empty hard gelatin capsule shell as claimed in any of the preceding claims wherein the dissolution of the capsule is less than 2 minutes. 12.A fast dissolving empty hard gelatin capsules shell as claimed in claims 1 to 7 shall optionally include colorants, opacifiers, sweeteners, silicon dioxide, plasticizers, preservatives and the like. ABSTRACT The present invention provides a fast dissolving empty hard gelatin capsule shell comprising a combination of gelatin, surfactant, and an acidulant. The disintegration time of the capsule shell is less than 2 minutes. A method for preparing fast dissolving empty hard gelatin capsule shell is also provided.

Documents:

140-mum-2003-abstract(complete).doc

140-mum-2003-cancelled page(29-01-2004).pdf

140-mum-2003-claim(granted)-(29-01-2004).doc

140-mum-2003-claim(granted)-(29-01-2004).pdf

140-mum-2003-claims(complete).doc

140-mum-2003-claims(complete).pdf

140-mum-2003-correspondance-received-290104.pdf

140-mum-2003-correspondance-received-310106.pdf

140-mum-2003-correspondance-received.pdf

140-MUM-2003-CORRESPONDENCE 17-6-2008.pdf

140-mum-2003-correspondence(16-10-2008).pdf

140-mum-2003-correspondence(ipo)-(25-08-2008).pdf

140-mum-2003-description (complete).pdf

140-mum-2003-description (provisional).pdf

140-mum-2003-form 1(03-02-2003).pdf

140-mum-2003-form 13(04-03-2008).pdf

140-mum-2003-form 18(31-01-2006).pdf

140-mum-2003-form 2(granted)-(29-01-2004).doc

140-mum-2003-form 2(granted)-(29-01-2004).pdf

140-mum-2003-form 3(03-02-2003).pdf

140-mum-2003-form 5(03-02-2003).pdf

140-mum-2003-form 5(29-01-2004).pdf

140-mum-2003-form-1.pdf

140-mum-2003-form-18.pdf

140-mum-2003-form-2(complete).doc

140-mum-2003-form-2(complete).pdf

140-mum-2003-form-26.pdf

140-mum-2003-form-3.pdf

140-mum-2003-form-5-290104.pdf

140-mum-2003-form-5.pdf

140-mum-2003-power of attorney(03-02-2003).pdf

140-mum-2003-power of authority(03-02-2003).pdf