Title of Invention	NOVEL HAIR GROWTH RETARDANT OR INHIBITOR
Abstract	The invention relates to a novel hair retardant formulation that when used in conjunction with conventional physical/ chemical hair removal means, delays the re-growth of hair and after repeated use retards the rate of hair growth.

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COMPLETE AFTER PROVISIONAL LEFT ON 13 .02 .2004 FORM 2 THE PATENTS ACT, 1970 COMPLETE SPECIFICATION (Section 10) "NOVEL HAIR GROWTH RETARD ANT OR INHIBITOR" Cadila Healthcare Limited, a company incorporated under the Companies Act, 1956, of Zydus Tower, Satellite Road, Ahmedabad 380 015, Gujarat India. The following specification particularly describes and ascertains the nature of the invention and the manner in which it is to be performed: Field of invention The present invention relates to a novel hair growth retardant or inhibitor that delays the re-growth of hair after repeated usage. Background of the invention Since ages, attempts have been and still are being made to reduce/remove excess or unwanted hair from various parts of the human body. The prior art documents many methods for this purpose most which suffer from one or more disadvantages. The most commonly used method for hair reduction/ removal in the Indian markets are liquid hair removers that contain thioglycolic acid as the key active ingredient. These work by breaking the protein bond of the human hair, thereby causing temporary hair removal. However, the use of the lotion results in uneven hair growth after repeated use. This makes the skin look and feel uneven. US Patent No. 6,375,948 discloses use of juniper or malt extracts in addition to an inhibitor and an enzyme. Similarly, other patents use some or other herbal composition on the ground that such compositions have anti-testosterone activity or have hair growth inhibiting properties. Summary of the invention The present invention provides a novel composition for hair growth retardation/ inhibition. The invention can be made as a thick cream as well as gel like formulation. The methods for making a cream or gel are well known to the professionals in the cosmetic industry. Both men and women can use this formulation on all parts of the body. The formulation does not directly remove hair like commercially available hair removers; but rather prolongs the time taken for hair to re-growth once they have been removed using this composition in conjunction with conventional physical/ chemical means like threading/ waxing/ shaving. In other words, the frequency of the need to shave decreases with regular use of the composition. The delayed re-growth is dependent upon the physiology of the person, his hair type, area of usage etc, but nevertheless, repeated usage (around 4-6 times) will show a noticeable change (delayed growth) in hair growth period. It has also been observed that the resultant hair, that eventually do grow, are thinner but feel normal, unlike the hair that grows after using conventional hair removers. The uniqueness of the composition of the present invention is in the fact that there is a synergistic response by the interaction among the constituents. Also, it has been noticed that prolonged 2 use of the composition of the present invention encourages complete stoppage of hair growth in the area of usage. Accordingly, the present invention provides a hair growth retarding composition comprising as active ingredients, a synergistic combination of Castor Oil, samudrafina (dry sea foam) and glycerin, in a cosmetic vehicle or a base, said Castor Oil, samudrafina and glycerin, being present in a weight ratio of 3.5 : 1.5 : 3 to 4.5 : 2.5 : 5, and the balance if any, consisting of one or more additives, humectants and/or excipients of the kind such as herein described. The present invention also provides process for the preparation of a hair growth retarding composition which comprises active ingredients, consisting of Castor Oil, samudrafina (dry sea foam) and glycerin, in a cosmetic vehicle or a base, said Castor Oil, samudrafina and glycerin, being present in a weight ratio of 3.5 : 1.5 : 3 to 4.5 : 2.5 : 5, and the balance if any, consisting of one or more additives, humectants and/or excipients of the kind such as herein described. The present invention has the following advantages: 1. Hair growth is retarded/ inhibited after repeated use. 2. Reduced necessity for threading/ waxing/ shaving due to delayed hair growth. 3. The user of the invention feels a fresh feeling upon use of the invention. 4. The composition of the invention is fast and easy to apply and does not cause any side effects. 5. The composition of the invention moisturizes & tightens the skin. 6. Long product shelf life. Usage Procedure The final composition of the present invention is to be applied and rubbed (for approximately 3-5 minutes) on the area where hair removal is desired till the formulation permeates in the skin. Thereafter, it should be wiped/ washed off. Then normal physical/ chemical hair removal procedures can be carried out. Mere use of the composition of the present invention without subsequent physical/ chemical procedures will not result in any benefits. Repeated use before physical/ chemical hair removal procedures will delay the time taken for re-growth of hair and thereby decrease the need for repeated threading, waxing, or shaving. Detailed description Principle active ingredients of the composition of the present invention are Castor Oil, glycerin, Walnut shell powder, samudrafina (dry sea foam). The individual ingredients, when 3 applied on the skin, do not give the desired effect. It is the combination of these ingredients in conjunction with physical hair removal means that will result in hair growth reduction. Castor oil when applied on the skin due to its inherent properties of lubrication makes skin slippery and the equipment used will tend to slide down the skin without producing the desired effect. Samudrafina, which is in powdered form does not adhere to the skin and does not produce any effect, while Glycerin, which is humectant by nature also makes the skin slippery. Walnut powder does not stay on the skin and as such does not give any abrasive action. A combination of these ingredients, which can be applied, rubbed and wiped out from the skin with oil in water type of emulsion, surprisingly acts as a good system in a synergistic manner. Walnut Powder: Walnut shells are collected and the extraneous matter adhering to the shells are removed. The shells are thoroughly washed first with mild disinfecting solution of water, which is followed by drying in the oven. The dried shells are first ground to coarser powder and then to fine powder. The powder is sifted through 40 mesh BIS sieve. The powder is further sieved through 80 mesh BIS and the coarse particles are removed. Only the powder with particles between 80 mesh and 40 mesh sieve are collected, dried and then autoclaved at 15 PSI steam pressure. Samudrafina: Crude Samudrafina collected from sea is separated from extraneous organic matter. It is dried. The dried powder is then washed with IPA / Ethyl Alcohol to get rid of entrapped organic matter, which is further dried and pulverised to between 40 - 80 mesh size. The chemicals used for dispersing the ingredients are emulsifiers like cetyl & cetostearyl alcohol, emollients, thickeners, water, preservatives, and neutralising agents. These experimental batches of 1 kg each were carried out on laboratory scale. The oil phase consisting of emulsifier, castor oil and preservative is prepared & maintained at high temperature (80- 85°C). Water phase consists of processed water, wetting agent, preservative, thickener, glycerine and other humactant is prepared and maintained at 80 +/- 2°C Oil phase at higher temperature is added slowly to water phase in a thin stream under high shear mixing, which is continued for 10-15 min. After end of mixing period, product is cooled to temperature of 70°C. When the neutralising agent is added further cooling is done 4 till 50°C temperature is obtained on which Samudrafina, scrub particles are added. Perfume is added at temperature of 45 °C after the cream has set. As mentioned earlier, the present invention relates to novel hair growth retarding composition comprising as active ingredients, a synergistic combination of Castor Oil, samudrafina (dry sea foam) and glycerin, in a cosmetic vehicle or a base, said Castor Oil, samudrafina and glycerin, being present in a weight ratio of 3.5 : 1.5 : 3 to 4.5 : 2.5 : 5, and the balance if any, consisting of one or more additives, humectants and/or excipients of the kind such as herein described. In a preferred embodiment, the 100 gm of said composition contains castor oil in an amount of from 17.5 to 22. 5g, said samudrafina is present in an amount of 7.5 to 12.5g and said glycerin is present in an amount of 15.0 to 25.0g, the balance consisting of conventional additives and excipients. In a preferred embodiment, said one or more additives, humectants and/or excipients are present in an amount of about 10 to 20 wt %, preferably 18.6 wt %, said active ingredients are present in an amount of about 50 wt % and the balance comprises said vehicle. In another preferred embodiment, said one or more additives, humectants and/or excipients are selected from walnut shell powder, cetyl alcohol, stearyl alcohol, anhydrous lanilin, apricot kernel oil, propyl paraben, propylene glycol, sodium lauryl sulfate, triethanolamine, arlacel-165, carbomer 934 NF, methyl paraben, starch and titanium dioxide In another preferred embodiment, each of said additives, humectants and/or excipients are present in an amount of from 0.0 to 5 wt%. In another preferred embodiment, said castor oil in present in an oil phase and said glycerin and said samudrafina are present in an aqueous phase, said composition being in the form of an oil in water type of emulsion. In another preferred embodiment, said castor oil in present in an oil phase and said glycerin is present in an aqueous phase, said composition being in the form of an oil in water type of emulsion. In another preferred embodiment, said oil phase is prepared by heating castor oil and adding one or solid additives one after the other, each said solid ingredient being added only after the complete dissolution of the previous solid ingredient. In another preferred embodiment, said water phase is prepared by heating demineralised water and adding thereto adding one or solid additives one after the other, said 5 sold ingredients being different from said solid ingredients added to said oil phase, the temperature of said water phase being at least 2°C less than the temperature of said oil phase. In another preferred embodiment, said oil phase and water phase are mixed together and emulsified and said walnut shell powder and said samudrafma are added to said emulsified product. In another preferred embodiment, the temperature of said oil phase is from 83 to 85°C. In another preferred embodiment, the temperature of said water phase is from 80 to 82°C provided that the difference in temperature between the two phases is at least 2°C. In another preferred embodiment, said oil phase at a temperature of about 85°C is added to water phase at a temperature of not more than about 81°C in a thin stream and subjected to high speed mixing, the mixture so obtained cooled to about 60°C; the cooled mixture is then neutralizing by addition of Triethanolamine and further cooled to about 45 °C to obtain a creamy product, starch and titanium dioxide are added to said creamy product followed by the addition of walnut shell powder and samudrafina, the product so obtained is homogenized and cooled followed by the addition of an additive such as perfume. The present invention will now be described in greater detail with reference to the following non limiting examples. Preparation of the composition The aqueous (water) phase consists of following: Dimineralized water Carbopol Sodium Lauryl Sulphate Triethanolamine Propylene Glycol Glycerine; Methyl & Proply paraben Manufacturing Procedure Preparation of water phase Demineralized water is heated to 80°C in a glass beaker/suitable vessel with laboratory stirrer. Carbopol in small quantities is added to the hot water without allowing any lump formation. Sodium Lauryl Sulphate is added to help dispersion of Carbopol. Methylparaben, Propyl paraben are dissolved in mixture of glycerin, Propylene Glycol by 6 warming an intermittant agitation. The solution is added to earbopol dispersion. The contents are maintained at about 80-82°C. Oil phase preparation Castor oil is warmed to 85°C into a suitable vessel. Solid ingredients glycerol monostearate, cetyl alcohol, cetosteryl alcohol 165 (Arlacel 165), apricot oil, anhydrous lanolin, are added in sequence in such a manner that the previous ingredient has dissolved totally before addition of the next ingredient. The oil phase is maintained at temperature between 83 - 85°C. Under all circumstances, the oil phase temperature should be at least 2°C higher than water phase. Emulsification Emulsification process needs to be carried out using a homogeniser and the temperature conditions need to followed strictly. Oil phase at temperature of about 85°C is added to water phase with homogeniser operating at 1400 RPM in a very thin stream. The approximate addition time is 5 to 7 minutes. On completion of transfer of oil phase to water phase the high speed mixing is continued for further period of about 10 minutes after which the homogeniser speed is reduced to 600 RPM gradually. Mixing is continued and product is allowed to cool to about 60°C. The product is neutralised further by addition of Triethanolamine solution. The product thickens during the process of neutralization. On complete addition of Triethanolamine, the homogeniser is replaced with scraper type of stirrer with speed of 48 RPM. The product is further cooled to about 45 to 50°C. Starch and Titanium Dioxide are mixed geometrically and added in small quantities to the thickened cream. The product is further mixed for about 10 minutes. Autoclaved Walnut and Samudrafina are mixed geometrically and added in small quantities to the product, which is further homogenized. Product is further cooled and kept overnight for maturation. Manufacture of product was carried out using laboratory stirrer, glass beakers and each batch consisted on 1 kg both size as per formulation attached. It is to be noted that the above is merely an indicative process & minor / irrelevant modifications to the above can be easily carried by those skilled in the art. Furthermore, it is also to kept in mind that further additives known in the cosmetic industry such as vitamin(s), skin tightening agents etc. can be easily added to the above during manufacturing without any major change in the manufacturing process. 7 3 Trial Batches data INGREDIENTS Batch 3 QTY./100 GM Exp. 2 QTY./100 GM Exp. 1 QTY./100 GM Glyceryl mono stearate, 4.00 gm Acid stable 4.00 gm SE 4.00 gm SE Cetyl alcohol 3.00 gm 3.00 gm 3.00 gm Stearyl alcohol 4.50 gm 4.50 gm 4.50 gm Arlacel-165 1.00 gm 1.00 gm 1.00 gm Anhydrous lanilin 0.50 gm 0.50 gm 0.50 gm , Apricot Kernel oil 0.50 gm 0.50 gm 0.50 gm Castor oil 20.00 gm 20.00 gm 20.00 gm Propyl paraben 0.10 gm 0.10 gm 0.10 gm Propylene glycol 2.00 gm 2.00 gm 2.00 gm Glycerine 20.00 gm 20.00 gm 20.00 gm Sodium lauryl sulfate 0.50 gm 0.50 gm 0.50 gm Triethanolamine 0.30 gm 0.30 gm 0.30 gm Carbomer 934 NF 0.20 gm 0.20 gm 0.20 gm Methyl paraben 0.20 gm 0.20 gm 0.20 gm Starch 3.00 gm 3.00 gm 3.00 gm Walnut Shell powder 5.00 gm 10.00 gm 10.00 gm Titanium dioxide 0.50 gm 0.50 gm 0.50 gm Samudrafin 10.00 gm 10.00 gm 10.00 gm D.M. Water to 100.00 gm 100.00 gm 100.00 gm 8 We claim: 1. A hair growth retarding composition comprising as active ingredients, a synergistic combination of Castor Oil, samudrafina (dry sea foam) and glycerin, in a cosmetic vehicle or a base, said Castor Oil, samudrafina and glycerin, being present in a weight ratio of 3.5 : 1.5 : 3 to 4.5 : 2.5 : 5, and the balance if any, consisting of one or more additives, humectants and/or excipients of the kind such as herein described. 2. A composition as claimed in claim 1 wherein 100 gm of said composition contains castor oil in an amount of from 17.5 to 22. 5g, said samudrafina is present in an amount of 7.5 to 12.5g and said glycerin is present in an amount of 15.0 to 25.0g, the balance consisting of conventional additives and excipients. 3. A composition as claimed in claim 1 or 2 wherein said one or more additives, humectants and/or excipients are present in an amount of about 10 to 20 wt %, preferably 18.6 wt %, said active ingredients are present in an amount of about 50 wt % and the balance comprises said vehicle. 4. A composition as claimed in any preceding claim wherein said one or more additives, humectants and/or excipients are selected from walnut shell powder, cetyl alcohol, stearyl alcohol, anhydrous lanilin, apricot kernel oil, propyl paraben, propylene glycol, sodium lauryl sulfate, triethanolamine, arlacel-165, carbomer 934 NF, methyl paraben, starch and titanium dioxide. 5. A composition as claimed in claim 4 wherein each of said additives, humectants and/or excipients are present in an amount of from 0.0 to 5 wt%. 6. A composition as claimed in any preceding claim wherein said castor oil in present in an oil phase and said glycerin and said samudrafina are present in an aqueous phase, said composition being in the form of an oil in water type of emulsion. 7. A process for the preparation of a hair growth retarding composition which comprises active ingredients, consisting of Castor Oil, samudrafina (dry sea foam) and glycerin, in a cosmetic vehicle or a base, said Castor Oil, samudrafina and glycerin, being present in a weight ratio of 3.5 : 1.5 : 3 to 4.5 : 2.5 : 5, and the balance if any, consisting of one or more additives, humectants and/or excipients of the kind such as herein described. 8. A process as claimed in claim 7 wherein 100 gm of said composition contains castor oil in an amount of from 17.5 to 22. 5g, said samudrafina is present in an amount of 7.5 to 12.5g and said glycerin is present in an amount of 15.0 to 25.0g, the balance consisting of conventional additives and excipients. 9 9. A process as claimed in claim 7 or 8 wherein said one or more additives, humectants and/or excipients are present in an amount of about 10 to 20 wt %, preferably 18.6 wt %, said active ingredients are present in an amount of about 50 wt % and the balance comprises said vehicle. 10. A process as claimed in any one of claims 7 to 9 wherein said one or more additives, humectants and/or excipients are selected from walnut shell powder, cetyl alcohol, stearyl alcohol, anhydrous lanilin, apricot kernel oil, propyl paraben, propylene glycol, sodium lauryl sulfate, triethanolamine, arlacel-165, carbomer 934 NF, methyl paraben, starch and titanium dioxide. 11. A process as claimed in claim 10 wherein each of said additives, humectants and/or excipients are present in an amount of from 0.0 to 5 wt%. 12. A process as claimed in any one of claims 7 to 11 wherein said castor oil in present in an oil phase and said glycerin is present in an aqueous phase, said composition being in the form of an oil in water type of emulsion. 13. A process as claimed in claim 12 wherein said oil phase is prepared by heating castor oil and adding one or solid additives one after the other, each said solid ingredient being added only after the complete dissolution of the previous solid ingredient. 14. A process as claimed in claim 13 wherein said water phase is prepared by heating demineralised water and adding thereto adding one or solid additives one after the other, said sold ingredients being different from said solid ingredients added to said oil phase, the temperature of said water phase being at least 2°C less than the temperature of said oil phase. 15. A process as claimed in claim 14 wherein said oil phase and water phase are mixed together and emulsified and said walnut shell powder and said samudrafina are added to said emulsified product. 16. A process as claimed in any one of claims 13 to 15 wherein the temperature of said oil phase is from 83 to 85°C. 17. A process as claimed in any one of claims 14 to 16 wherein the temperature of said water phase is from 80 to 82°C provided that the difference in temperature between the two phases is at least 2°C. 18. A process as claimed in any one of claims 15 to 17 wherein said oil phase at a temperature of about 85°C is added to water phase at a temperature of not more than about 81°C in a thin stream and subjected to high speed mixing, the mixture so obtained cooled to about 60°C; the cooled mixture is then neutralizing by addition of 10 Triethanolamine and further cooled to about 45°C to obtain a creamy product, starch and titanium dioxide are added to said creamy product followed by the addition of walnut shell powder and samudrafina, the product so obtained is homogenized and cooled followed by the addition of an additive such as perfume. 19. A hair growth retarding composition substantially as herein described. 20. A process for preparing a hair growth retarding composition substantially as herein described. 11

Documents:

1056-mum-2002-abstract(13-2-2004).pdf

1056-mum-2002-abstract-(13-3-2004).doc

1056-mum-2002-abstract-provisional.doc

1056-mum-2002-abstract-provisional.pdf

1056-mum-2002-claims(granted)-(13-2-2004).pdf

1056-mum-2002-claims(granted)-(13-3-2004).doc

1056-mum-2002-claims-complete.doc

1056-mum-2002-claims-complete.pdf

1056-mum-2002-correspondence(29-8-2007).pdf

1056-mum-2002-correspondence(ipo)-(25-01-2008).pdf

1056-mum-2002-correspondence-received-120204.pdf

1056-mum-2002-correspondence-received-150103.pdf

1056-mum-2002-correspondence-received-201102.pdf

1056-mum-2002-correspondence-received.pdf

1056-mum-2002-descripiton (complete).pdf

1056-mum-2002-descripiton (provisional).pdf

1056-mum-2002-form 1(28-11-2002).pdf

1056-mum-2002-form 1(31-12-2002).pdf

1056-mum-2002-form 18(8-9-2006).pdf

1056-mum-2002-form 2(granted)-(13-2-2004).pdf

1056-mum-2002-form 2(granted)-(13-3-2004).doc

1056-mum-2002-form 3(8-11-2002).pdf

1056-mum-2002-form 4(13-2-2004).pdf

1056-mum-2002-form 5(13-2-2004).pdf

1056-mum-2002-form-1.pdf

1056-mum-2002-form-18.pdf

1056-mum-2002-form-2-complete.pdf

1056-mum-2002-form-2-provisional.pdf

1056-mum-2002-form-26.pdf

1056-mum-2002-form-3.pdf

1056-mum-2002-form-4.pdf

1056-mum-2002-form-5.pdf

1056-mum-2002-granted.pdf

1056-mum-2002-power of authority(15-1-2003).pdf