TRANSDERMAL ANTI-DEMENTIA ACTIVE AGENT FORMULATIONS AND METHODS FOR USING THE SAME

• US 20100178307A1
• Filed: 01/13/2010
• Published: 07/15/2010
• Est. Priority Date: 01/13/2010
• Status: Abandoned Application

• Current Assignee: Teikoku Pharma USA Incorporated (Teikoku Seiyaku)
• Original Assignee: Teikoku Pharma USA Incorporated (Teikoku Seiyaku)
• Inventors: Katori Stowell, Yoshiko, Wen, Jianye
• Application Number:
  US12/687,034
• Publication Number:
  US 20100178307A1
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia

Abstract

Transdermal anti-dementia active agent systems are provided. Aspects of systems include a transdermal preparation, first overlay and second overlay. Also provided are methods of using the systems, e.g. for administering an anti-dementia active agent to a subject.

Claims

1. A transdermal anti-dementia active agent system, said system comprising:

(a) a transdermal preparation comprising;

a backing;

an active agent reservoir layer comprising an anti-dementia active agent; and

an adhesive layer;

(b) a first overlay configured to at least partially cover the transdermal preparation when topically applied; and

(c) a second overlay configured to at least partially cover the first overlay when topically applied.

2. The system according to claim 1, wherein the first overlay is configured to entirely cover the transdermal preparation when topically applied.

3. The system according said claim 2, wherein the second overlay is configured to entirely cover the first overlay when topically applied.

4. The system according to claim 3, wherein the anti-dementia active agent is donepezil.

5. The system according to claim 4, wherein donepezil is present as a salt.

6. The system according to claim 5, wherein the donepezil salt is present in an amount ranging from 0.5% to 50% (w/w).

7. The system according to claim 1, wherein the active agent reservoir layer comprises:

an aminated polymer;

a polyhydric alcohol;

a carboxylic acid ester; and

an acrylic polymer.

8. The system according to claim 7, wherein the aminated polymer is a copolymer comprising a dialkylaminoalkyl(meth)acrylate and a monomer unit selected from an alkyl(meth)acrylate, a hydroxyalkyl(meth)acrylate, and a combination thereof.

9. The system according to claim 8, wherein the aminated polymer is a methyl(meth)acrylate-butyl (meth)acrylate-dimethylaminoethyl(meth)acrylate copolymer.

10. The system according to claim 7, wherein the carboxylic acid ester is selected from an ester of a polyvalent carboxylic acid and a monohydroxy alcohol, an ester of a fatty acid and a polyhydric alcohol, and a combination thereof.

11. The system according to claim 10, wherein the ester of a polyvalent carboxylic acid and a monohydroxy alcohol is an alkyl citrate ester and/or an alkyl sebacate ester.

12. The system according to claim 10, wherein said ester of a fatty acid and a polyhydric alcohol is at least the one selected from the group consisting of a sorbitan fatty acid ester, a propylene glycol fatty acid ester and a glycerin fatty acid ester.

13. The system according to claim 7, wherein the polyhydric alcohol is a sugar alcohol and/or a glycol.

14. The system according to claim 13, wherein the polyhydric alcohol is at least the one selected from the group consisting of glycerin, propylene glycol, dipropylene glycol, butylene glycol and polyethylene glycol.

15. The system according to claim 1, wherein the transdermal preparation comprises a rate-controlling membrane positioned between the active agent reservoir layer and the adhesive layer.

16. The system according to claim 1, wherein the adhesive layer comprises an acrylic polymer.

17. The system according to claim 16, wherein the adhesive layer comprises a carboxylic acid ester.

18. The system according to claim 17, wherein the carboxylic acid ester of the adhesive layer is selected from an ester of a polyvalent carboxylic acid and a monohydroxy alcohol, an ester of a fatty acid and a polyhydric alcohol, and a combination thereof.

21. The system according to claim 1, further comprising a release liner associated with the adhesive layer.

19-20. -20. (canceled)

22-41. -41. (canceled)

42. A structure comprising:

(a) a transdermal preparation comprising;

a backing;

an active agent reservoir layer comprising an anti-dementia active agent; and

an adhesive layer;

(b) a first overlay at least partially covering the transdermal preparation; and

(c) a second overlay at least partially covering the first overlay.