Claims for Patent: 6,410,048

Summary for Patent: 6,410,048

Title:	Prolamin-plant polar lipid combination, preparation method and applications
Abstract:	The invention provides a prolamine-plant polar lipid association, wherein the prolamine and plant polar lipid components are present in such proportions so that stable films can be obtained with this association, which is preferably in the form of a hydro-alcoholic gel comprising: 20-40% w/w of prolamines, preferably gliadin; 0.1-5% w/w of ceramides, preferably wheat ceramides; hydro-ethanolic solution (35 to 80.degree.) ad 100%. This association may be used for preparing films, patches, aerosols for use in the delivery of active substances such as therapeutic and cosmetic agents.
Inventor(s):	Fotinos; Spiros (Athens, GR)
Assignee:	Laboratories Lavipharm S.A. (Paris, FR)
Application Number:	09/554,486
Patent Claims:	1. A patch comprising a backing film, a removable layer and an association layer between the backing film and the removable layer; wherein the association layer comprises prolamine and plant polar lipid, wherein the prolamine and the plant polar lipid are provided in proportions sufficient to enable formation of a stable patch, and wherein the patch exhibits skin adhesion properties. 2. The patch according to claim 1, wherein the association layer is formed using a hydro-ethanolic gel comprising 20 to 40% w/w prolamine and 0.1 to 5% w/w plant polar lipid. 3. The patch according to claim 2; wherein the association layer is formed using a hydro-ethanolic gel comprising 31% w/w prolamine, 1.3% w/w plant polar lipid; wherein the prolamine comprises wheat prolamines and the plant polar lipid comprises wheat polar lipids. 4. The patch according to claim 1, wherein the association layer further comprises a plasticizing agent. 5. The patch according to claim 1; wherein the association layer is formed using a hydro-ethanolc gel comprising 27 to 30% w/w prolamine, 1-2% w/w plant polar lipid, 2.5-5% w/w glycerol and 6-9% sorbitol; wherein the plant polar lipid comprises ceramide. 6. The patch according to claim 1, wherein the association layer further comprises an active substance selected from the group consisting of therapeutic agents, cosmetic agents and active agents. 7. The patch according to claim 6, wherein the active substance is a therapeutic agent selected from the group consisting of systemic or topical treatment agents including penicillin, tetracycline and erythomycin; analgesics including morphine and meperidine; antipyretics and antiinflammatory agents including salicylates and indole derivatives; antispasmodics including scopolamine and atropine; hormonal agents including cortisone, cortisol and calcitonin; local anesthetics including procaine, lidocaine and xylocaine; sympathomimetic drugs including epinephrine and amphetamine; antiparasitic agents including metronidasole, fenthion and cythioate; hypoglycemic drugs including insulin and insulin derivatives; anti-acne agents including salicylic acid, benzoyl peroxide and retinoic acid; nutritional agents including vitamins, essential amino acids and essential fats. 8. The patch according to claim 1, wherein the association layer further comprises an active substance selected from the group consisting of anti-hyperpigmentation agents, anti-blotching agents, anti-aging agents, eye contour agents, slimming agents, anti-cellulite agents, soothing/sunburn anti-irritating agents, skin firming and lifting agents, anti-elastase agents and anti-collagenase agents, free radical scavengers; seboregulators, hydratives, alpha-hydroxy acids and vitamins. 9. The patch according to claim 1, wherein the association layer further comprises an active substance selected from the group consisting of antimicrobials including penicillin, tetracycline and erythromycin; anti-inflammatory agents including salicylates and indole derivatives; hemostatic agents including negatively charged phospholipids and kaolin; skin growth agents including collagenase inhibitors and wound healing agents including povidone-iodide, hyaluronic acid and its derivatives, mastichinum oil from Pistachia lentiscus var and Chia. 10. The patch according to claim 6, wherein the patch comprises at least two association layers, wherein the association layers contain different concentrations of active substances. 11. The patch according to claim 1, wherein the prolamine comprises gliadin. 12. The patch according to claim 1, wherein the plant polar lipid comprises a high proportion of ceramides and glycosylceramides. 13. The patch according to claim 12, wherein the plant polar lipid comprises cereal polar lipid. 14. The patch according to claim 13, wherein the cereal polar lipid comprises wheat polar lipid. 15. A method of making a hydro-alcoholic gel formulation for use in preparing the association layer of claim 1, comprising: (a) heating a hydro-ethanolic solution to 42-48.degree. C.; (b) adding prolamine to the hydro-ethanolic solution under vigorous stirring to form a dispersion; (c) adding plant polar lipid to the dispersion; (d) stirring the dispersion while maintaining the temperature at 42-48.degree. C. for 20 to 40 minutes; and, (e) allowing the dispersion to cool under ambient conditions with gentle stirring. 16. The method of claim 15, wherein additives are added to the dispersion along with the plant polar lipid. 17. A method for administering an active substance to a human, comprising forming a patch in situ on the skin of the human, wherein the patch comprises an association layer comprising a prolamine and a plant polar lipid. 18. The method of claim 17, wherein the wherein the association layer is formed using a hydro-ethanolic gel comprising 20 to 40% w/w prolamine and 0.1 to 5% w/w plant polar lipid. 19. The method of claim 17; wherein the association layer is formed using a hydro-ethanolic gel comprising 31% w/w prolamine, 1.3% w/w plant polar lipid; wherein the prolamine comprises wheat prolamines and the plant polar lipid comprises wheat polar lipids. 20. The method of claim 17; wherein the association layer is formed using a hydro-ethanolic gel comprising 27 to 30% w/w prolamine, 1-2% w/w plant polar lipid, 2.5-5% w/w glycerol and 6-9% sorbitol; wherein the plant polar lipid comprises ceramide. 21. The method of claim 17, wherein the active substance is selected from the group consisting of therapeutic agents, cosmetic agents and active agents. 22. The method of claim 17, wherein the active substance is selected from the group consisting of systemic or topical treatment agents including penicillin, tetracycline and erythomycin; analgesics including morphine and meperidine; antipyretics and antiinflammatory agents including salicylates and indole derivatives; antispasmodics including scopolamine and atropine; hormonal agents including cortisone, cortisol and calcitonin; local anesthetics including procaine, lidocaine and xylocaine; sympathomimetic drugs including epinephrine and amphetamine; antiparasitic agents including metronidasole, fenthion and cythioate; hypoglycemic drugs including insulin and insulin derivatives; anti-acne agents including salicylic acid, benzoyl peroxide and retinoic acid; nutritional agents including vitamins, essential amino acids and essential fats. 23. The method of claim 17, wherein the active substance is selected from the group consisting of anti-hyperpigmentation agents, anti-blotching agents, anti-aging agents, eye contour agents, slimming agents, anti-cellulite agents, soothing/sunburn anti-irritating agents, skin firming and lifting agents, anti-elastase agents and anti-collagenase agents, free radical scavengers; seboregulators, hydratives, alpha-hydroxy acids and vitamins. 24. The method of claim 17, wherein the active substance is selected from the group consisting of antimicrobials including penicillin, tetracycline and erythromycin; anti-inflammatory agents including salicylates and indole derivatives; hemostatic agents including negatively charged phospholipids and kaolin; skin growth agents including collagenase inhibitors and wound healing agents including povidone-iodide, hyaluronic acid and its derivatives, mastichinum oil from Pistachia lentiscus var and Chia. 25. The method of claim 17, wherein the prolamine comprises gliadin. 26. The method of claim 17, wherein the plant polar lipid comprises a high proportion of ceramides and glycosylceramides. 27. The method of claim 17, wherein the plant polar lipid comprises cereal polar lipid. 28. The method of claim 17, wherein the cereal polar lipid comprises wheat polar lipid.

Details for Patent 6,410,048

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2017-11-13