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Claims for Patent: 4,906,463

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Claims for Patent: 4,906,463

Title: Transdermal drug-delivery composition
Abstract:A solid state, resilient laminated composite for administering a drug transdermally consisting of a multiplicity of spaced structural laminas of a resilient elastomer, one of which forms the top of the composite, a viscoelastic hydrophobic polymer lamina containing propylene glycol monolaurate interposed between each structural lamina and a pressure-sensitive adhesive lamina that provides the basal surface of the composite and consists of a blend of a pressure-sensitive adhesive, drug and propylene glycol monoalaurate.
Inventor(s): Cleary; Gary W. (San Mateo, CA), Roy; Samir (Redwood City, CA)
Assignee: Cygnus Research Corporation (Redwood City, CA)
Application Number:07/179,423
Patent Claims: 1. A pharmaceutical composition for transdermal or transmucosal administration comprising a nonaqueous mixture of a polymer, a drug and a permeation enhancing amount of a fatty acid ester or fatty alcohol ether of a C.sub.2 to C.sub.4 alkanediol where each fatty acid or fatty alcohol portion of the ester or ether is of about 8 to 22 carbon atoms.

2. The pharmaceutical composition of claim 1 wherein the composition is in the form of a solid state transdermal drug delivery device.

3. The pharmaceutical composition of claim 2 wherein the drug is estradiol or fentanyl.

4. The pharmaceutical composition of claim 2 wherein the device is a laminated composite of a reservoir layer and a pressure sensitive adhesive layer.

5. The pharmaceutical composition of claim 4 wherein the drug and the fatty acid ester or fatty alcohol ether are both contained primarily in the reservoir layer.

6. The pharmaceutical composition of claim 1 wherein the ester is a monoester and the ether is a monoether.

7. A pharmaceutical composition for transdermal or transmucosal administration comprising a nonaqueous mixture of a polymer, a drug and a permeation enhancing amount of a fatty acid monoester of propylene glycol.

8. The pharmaceutical composition of claim 7 wherein the fatty acid monoester of propylene glycol is propylene glycol monolaurate.

9. The pharmaceutical composition of claim 8 wherein the drug is estradiol or fentanyl.

10. A method of enhancing the permeation of a body surface to a drug administered to the surface comprising coadministering to the surface a permeation enhancing amount of a fatty acid ester or a fatty alcohol ether of a C.sub.2 to C.sub.4 alkanediol where each fatty acid or fatty alcohol portion of the ester or ether is of about 8 to 22 carbon atoms and wherein said ester or ether is administered from a nonaqueous mixture comprising a polymer and said ester or ether.

11. The method of claim 10 wherein the drug is estradiol or fentanyl.

12. A method of enhancing the permeation of skin to estradiol or fentanyl comprising coadministering to the skin a permeation enhancing amount of propylene glycol monolaurate from a nonaqueous mixture of estradiol or fentanyl, a polymer, and propylene glycol monolaurate.
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