Matrix-type device for the transdermal delivery of testosterone applied to the non-scrotal skin

• US 20030215487A1
• Filed: 05/17/2002
• Published: 11/20/2003
• Est. Priority Date: 05/17/2002
• Status: Abandoned Application

• Current Assignee: Il-Yang Pharm. Co., Ltd.
• Original Assignee: IL Yang Pharm Company Limited Republic of Korea
• Inventors: Kim, Dong-Yeun, Kim, Sookyun, Park, Dong-Woo
• Application Number:
  US10/150,143
• Publication Number:
  US 20030215487A1
• Time in Patent Office: Days
• US Class Current: 424/449
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 47/22 Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/7061 Polyacrylates

Abstract

The present invention relates to a matrix-type device for the transdermal delivery of testosterone comprising (i) a matrix layer containing a) a therapeutically effective amount of testosterone or the salt thereof, b) an adhesive polymer, and c) a penetration enhancer comprising N-methylpyrrolidone and oleoylsarcosine, and, (ii) a backing layer of polyurethane. The device of the present invention is applicable to a non-scrotal skin as compared with a known matrix-type device for the transdermal delivery and has an excellent skin-adhesion and has less tendencies of crystallizing testosterone.

Claims

1. A matrix-type device for transdermal delivery of testosterone comprising

(i) a matrix layer containing

a) a therapeutically effective amount of testosterone or the salt thereof,

b) an adhesive polymer, and

c) a penetration enhancer comprising N-methylpyrrolidone and oleoylsarcosine, and,

(ii) a backing layer of polyurethane.

2. The device according to claim 1 wherein the penetration enhancer further comprises diethyltoluamide and/or sorbitan monooleate.

3. The device according to claim 1, further comprising a release liner.

4. The device according to claim 1 or 2 wherein the testosterone or the salt thereof is in an amount of 2 to 5% of weight based on the total weight of the matrix layer.

5. The device according to claim 1 or 2 wherein the penetration enhancer is in an amount of 2 to 40% of weight based on the total weight of the matrix layer.

6. The device according to claim 1 or 2 wherein the polyurethane backing layer has a moisture permeability of 500 to 5000 g/m².24 hr.

7. The device according to claim 6 wherein the polyurethane backing layer has a flexibility of from 2 to 10 folds.

8. The device according to claim 1 wherein thickness of the matrix layer has a thickness of from 20 to 500 μ

m and the backing layer has a thickness of from 30 to 500 μ

m.