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Claims for Patent: 7,638,140

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Claims for Patent: 7,638,140

Title:Adhesive mixture for transdermal delivery of highly plasticizing drugs
Abstract:Transdermal drug delivery patches and methods of their production are described. The patches can be made such that the accommodate highly plasticizing drugs such as selegiline and/or the use of protonated forms of various drugs.
Inventor(s): Govil; Sharad K. (Essex, VT), Weimann; Ludwig J. (Burlington, VT)
Assignee: Mylan Technologies, Inc. (St. Albans, VT)
Application Number:10/730,561
Patent Claims: 1. A therapeutic adhesive formulation comprising between about 65% and about 97% by weight of an acrylic polymeric adhesive which includes between about 40% and about 90% of a C.sub.4-C.sub.12 alkyl acrylate; between about 10% and about 40% by weight of a C.sub.1-C.sub.3 alkyl acrylate hardening monomer; between about 1% and about 20% by weight of a functionalizing monomer which facilitates crosslinking; and between about 3% and about 35% by weight of said mixture, of a highly plasticizing drug component.

2. The therapeutic adhesive formulation of claim 1 wherein said highly plasticizing drug component comprises a liquid drug component.

3. The therapeutic adhesive formulation of claim 1 wherein said highly plasticizing drug component comprises a drug component dissolved in a plasticizing solvent.

4. The therapeutic adhesive formulation of claim 3 wherein drug component comprises a drug selected from the group consisting of propranolol, ketorolac, buprenorphine, scopolamine, terbutaline, clonidine, morphine, terazosin, prazosine, diliazem, verapamil, and ciproflaxocin.

5. The therapeutic adhesive formulation of claim 4 wherein said plasticizing solvent comprises a nonaqueous plasticizing solvent.

6. The therapeutic adhesive formulation of claim 3 wherein said C.sub.4-C.sub.12 alkyl acrylate is selected from the group consisting of 2-ethylhexyl acrylate, butyl acrylate, n-decyl, n-nonyl, 2-ethyloctyl, isooctyl and dodecyl acrylate.

7. The therapeutic adhesive formulation of claim 3 wherein said C.sub.4-C.sub.12 alkyl acrylate is provided in an amount of between bout 60% and about 80% by weight based on the weight of said adhesive.

8. The therapeutic adhesive formulation of claim 3 wherein said highly plasticizing drug component comprises a liquid drug component.

9. A therapeutic adhesive formulation comprising an acrylic polymeric adhesive which includes between about 40% and about 90% of a C.sub.4-C.sub.12 alkyl acrylate; between about 10% and about 40% by weight of a C.sub.1-C.sub.3 alkyl acrylate hardening monomer; between about 1% and about 15% by weight of a functionalizing monomer which facilitates crosslinking; and a therapeutically effective amount of a highly plasticizing drug component, wherein said blend is substantially anhydrous.

10. The therapeutic adhesive formulation of claim 9 wherein said highly plasticizing drug component comprises a drug component dissolved in a plasticizing solvent.

11. The therapeutic adhesive formulation of claim 10 wherein said drug component comprises a drug selected from the group consisting of propranolol, ketorolac, buprenorphine, scopolamine, terbutaline, clonidine, morphine, terazosin, prazosine, diliazem, verapamil, and ciproflaxocin.

12. The therapeutic adhesive formulation of claim 11 wherein said plasticizing solvent comprises a nonaqueous plasticizing solvent.

13. A therapeutic adhesive formulation comprising between about 65% and about 97% by weight of an acrylic polymeric adhesive which includes a C.sub.4-C.sub.12 alkyl acrylate and a C.sub.1-C.sub.3 alkyl acrylate hardening monomer, and between about 3% and about 35% by weight based on the weight of said mixture of a highly plasticizing drug.

14. A method of producing a therapeutic adhesive formulation for use in a transdermal patch comprising the steps of: selecting an acrylic polymeric adhesive which is suitable for use with highly plasticizing drugs based upon it's content of between about 40% and about 90% of a C.sub.4-C.sub.12 alkyl acrylate and between about 10% and about 40% by weight of a C.sub.1-C.sub.4 alkyl acrylate hardening monomer; and mixing said acrylic polymeric adhesive with a highly plasticizing drug in an amount of between about 3% and about 65% by weight based on the weight of said mixture.
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