Claims for Patent: 5,300,291

Summary for Patent: 5,300,291

Title:	Method and device for the release of drugs to the skin
Abstract:	A method of increasing the adhesiveness of a shaped pressure sensitive adhesive, comprising adding an adhesiveness and drug release increasing amount of a clay to said adhesive prior to casting of the adhesive. A dermal composition comprising a drug, a pressure sensitive adhesive, an adhesiveness increasing amount of a clay and a solvent. A dermal composition comprising a drug, a multipolymer of ethylene vinyl acetate, an acrylic polymer, a natural or synthetic rubber and a clay, along with optional ingredients known for use in transdermal drug delivery systems.
Inventor(s):	Sablotsky; Steven (Miami, FL), Gentile; Joseph A. (Plantation, FL)
Assignee:	Noven Pharmaceuticals, Inc. (Miami, FL)
Application Number:	07/671,709
Patent Claims:	1. A method of increasing the adhesiveness of a pressure sensitive adhesive composition comprising an admixture of a natural or synthetic rubber and a multipolymer comprising a ethylene/vinyl acetate polymer and an acrylic polymer, in which the ratio by weight of the ethylene/vinyl acetate polymer to the acrylic polymer is about 1:20 to about 20:1 and the ratio by weight of the multipolymer to the rubber is about 1:10 to about 30:1. said method comprising the step of admixing said rubber, said acrylic polymer, said ethylene/vinyl acetate polymer, a drug, and at least one clay, wherein the resulting composition comprises an adhesiveness increasing amount of clay, said amount of clay being from about 0.1 to about 20% by weight of said resulting composition, wherein the clay is a natural or synthetic clay selected from the group consisting of hydrated aluminum silicate, kaolinite, montmorillonite, atapulgite, illite, bentonite, and halloysite. 2. The method of claim 1, in which the drug comprises less than about 10% by weight of the composition. 3. The method of claim 1, in which the drug comprises less than about 5% by weight of the composition. 4. The method of claim 1, in which the clay is bentonite. 5. The method of claim 1, in which the clay is present in an amount of about 0.1 to about 6% by weight of the composition. 6. The method of claim 5, in which the drug is a steroid and the clay is present in an amount of about 0.1 to about 3% by the weight of the composition. 7. The method of claim 1, in which the drug is 17-.beta.-estradiol. 8. The method of claim 1, in which the ratio of the multipolymer to the rubber is from about 1:5 to about 20:1. 9. The method of claim 8, in which the ratio of multipolymer to rubber is about 1:2 to about 15:1. 10. The method of claim 9, in which the drug is an estrogen, the ratio of multipolymer to rubber is about 3:1, and the amount of clay is about 0.1% to about 3%. 11. A dermal composition comprising an admixture of a drug, a pressure sensitive adhesive composition comprising a natural or synthetic rubber, and a multipolymer comprising a ethylene/vinyl acetate polymer and an acrylic polymer, in which the ratio by weight of the ethylene/vinyl acetate polymer to the acrylic polymer is about 1:20 to about 20:1, and the ratio by weight of the multipolymer to the rubber is about 1:10 to about 30:1, and further comprising from about 0.1 to about 20% by weight of an adhesiveness increasing amount of at least one natural or synthetic clay selected from the group consisting of hydrated aluminum silicate, kaolinite, montmorillonite, atapulgite, illite, bentonite, and halloysite. 12. The composition of claim 11, in which the clay is bentonite. 13. The composition of claim 11, which comprises at least one liquid solvent for one or more of the components of the composition. 14. The composition of claim 11, which comprises as approximate percent by weight, about 0.5 to about 50% of the drug, about 0.5 to about 20% of clay and about 0.5 to about 20% of the solvent. 15. The composition of claim 13, in which the solvent comprises a glycol. 16. The composition of claim 11 in which the clay is present in an amount of about 0.1 to about 6% by weight of the composition. 17. The composition of claim 16, in which the clay is present in an amount of about 0.1 to about 3% by weight of the composition. 18. The composition of claim 11, in which the drug is a steroid. 19. The composition of claim 19, in which the steroid is 17 .beta.-estradiol and the clay is bentonite. 20. The composition of claim 19, in which the bentonite is present in an amount of from about 0.1% to about 3%. 21. The composition of claim 15 in which the glycol is selected from the group consisting of propylene and butylene glycols. 22. The composition of claim 11, in which the multipolymer to rubber ratio is from about 1:5 to about 20:1. 23. The composition of claim 22, in which the ratio of multipolymer to rubber is from about 1:2 to 15:1. 24. The composition of claim 23, in which the drug is an estrogen, the ratio of multipolymer to rubber is about 3:1, and the amount of clay is about 0.1% to about 3%. 25. The composition of claim 11, in the form of a shaped article having two opposed faces, a backing on one face, and a release liner on the other. 26. The composition of claim 11, further comprising a backing layer. 27. The composition of claim 11, further comprising a release liner. 28. The composition of claim 11, which is a multiphase system. 29. The composition of claim 11, comprising a first phase containing a first polymer and a second phase containing a second polymer. 30. The composition of claim 27, wherein the first polymer interpenetrates into the second polymer. 31. The composition of claim 11, further comprising a tackifying agent. 32. The composition of claim 11, wherein said ethylene-vinyl acetate polymer comprises between about 4 to 50% by weight of vinyl acetate. 33. The composition of claim 11, wherein the rubber comprises a polyisobutylene. 34. The composition of claim 11, wherein the acrylic polymer contains at least 50% by weight of acrylate or alklyacrylates monomeric units. 35. A method of producing the composition as claimed in claim 11, comprising the steps of mixing the components together in the presence of a solvent, coating the mixture onto a release liner, and removing an lower molecular weight solvents. 36. A method as claimed in claim 33, further comprising the step of joining a backing layer to the mixture.