Method and device for the release of drugs to the skin

• US 5,686,099 A
• Filed: 05/26/1993
• Issued: 11/11/1997
• Est. Priority Date: 03/04/1988
• Status: Expired due to Term

• Current Assignee: Noven Pharmaceuticals Inc (Hisamitsu Pharmaceutical Company Incorporated)
• Original Assignee: Noven Pharmaceuticals Inc (Hisamitsu Pharmaceutical Company Incorporated)
• Inventors: Sablotsky, Steven, Gentile, Joseph A.
• Primary Examiner(s): Webman, Edward J.
• Application Number:
  US08/067,001
• Time in Patent Office: 1,630 Days
• Field of Search: 424/78.18, 424/448, 424/449, 424/443, 424/447, 514/772.4, 602/52, 602/54, 602/55
• US Class Current: 424/449
• CPC Class Codes: A61F 13/0276 Apparatus or processes for manufacturing adhesive dressings or bandages
• CPC Class Codes: A61K 9/7038 Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
• CPC Class Codes: A61K 9/7053 obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
• CPC Class Codes: A61K 9/7061 Polyacrylates
• CPC Class Codes: A61K 9/7076 the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins
• CPC Class Codes: A61L 15/18 containing inorganic materials
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: A61L 15/585 Mixtures of macromolecular compounds
• CPC Class Codes: B26F 1/384 using rotating drums
• CPC Class Codes: B26F 1/44 Cutters therefor; Dies therefor
• CPC Class Codes: C08L 31/04 Homopolymers or copolymers of vinyl acetate

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.

Claims

1. A dermal composition comprising a mixture of 0.1 to 50 by dry weight of a drug, a pressure sensitive adhesive, a liquid solvent for one or more of the components of the composition and about 0.1 to about 10% by dry/weight of the total composition of clay to increase the adhesiveness of the composition.

2. The composition of claim 1, in which the clay is selective from the group consisting of hydrated aluminum silicate, kaolinite, montmorillonite, atapulgite, illite, bentonite, and halloysite.

3. The composition of claim 2, wherein said adhesive comprises a multipolymer containing vinyl acetate and ethylene monomers, and an acrylic polymer and a natural or synthetic rubber.

4. The composition of claim 3 in which the clay is bentonite.

5. A composition of claim 1 comprising 17-beta-estradiol, a pressure sensitive adhesive, a lower molecular weight glycol and an adhesiveness increasing amount of clay.

6. The transdermal drug delivery device of claim 5 comprising an adhesiveness increasing effective amount of bentonite.

7. The composition of claim 1, comprising 17-beta-estradiol, a multipolymer containing acrylate and ethylene vinyl acetate monomers, a natural or synthetic rubber and a clay.

8. The composition of claim 7 in which the clay is selected from the group consisting of hydrated aluminum silicate, kaolinite, montmorillonite, atapulgite, illite, bentonite, and halloysite.

9. The composition of claim 8, additionally comprising a solvent for the 17-beta-estradiol.

10. The composition of claim 7, which comprises as approximate percent by dry weight, 0.5 to 50% of the drug, 10 to 90% of the multipolymer, 2% to 20% of a rubber, 0.5 to 10% of a clay and 0.5 to 10% of a solvent for the drug.

11. The composition of claim 10 which comprises about 0.5% to about 3% dry weight of a clay.

23. A dermal composition of claim 1, wherein the drug is selected from one or more of the group consisting of an estrogen and nitroglycerin.

24. A dermal composition of claim 1, which is free of water.

12. A multi-phase dermal composition comprising a first phase comprising a pressure sensitive adhesive and in admixture therewith, one or more additional phases containing a polymer, 0.1 to 50% by dry weight of the composition of drugs, a solvent for one or more of the components of the composition and about 0.1 to about 10% by dry weight of the composition of clay.

13. The composition of claim 12, in which the clay is selected from the group consisting of hydrated aluminum silicate, kaolinite, montmorillonite, atapulgite, illite, bentonite, and halloysite.

14. The composition of claim 13 which comprises a drug, a multipolymer containing vinyl acetate and ethylene monomers, an acrylic polymer, a natural or synthetic rubber and a glycol.

15. The composition of claim 13, in which the clay is bentonite.

16. The composition of claim 13 in which the clay is present in an amount of from about 0.5 to about 3% by dry weight.

17. The composition of claim 12 in which the clay is present in an amount of from about 0.5 to about 3% by dry weight.

18. The composition of claim 13, in which the drug is 17-beta-estradiol.

19. The composition of claim 14, in which the drug is 17-beta-estradiol.

20. The composition of claim 15, in which the drug is 17-beta-estradiol.

21. The composition of claim 16, in which the drug is 17-beta-estradiol.

22. The composition of claim 17, in which the drug is 17-beta-estradiol.

25. A dermal composition of claim 12, wherein the drug is selected from the group consisting of an estrogen and nitroglycerin and mixtures thereof.

26. A dermal composition of claim 12, which is free of water.

27. A dermal composition comprising a pressure sensitive adhesive, 0.1 to 50% by dry weight of drug, and about 0.1 to 6% by dry weight of clay to increase the adhesiveness of the composition.

28. A dermal composition of claim 27, wherein the drug is selected from one or more of the group consisting of an estrogen and nitroglycerin.

29. A dermal composition of claim 27, which is substantially free of water.

30. A dermal composition of claim 27, which contains a drug-impermeable backing on a first side of said dermal composition and a protective release liner on a second side which is opposite said first side of said dermal composition.