Transdermal hormone patch

• US 5,985,311 A
• Filed: 01/22/1998
• Issued: 11/16/1999
• Est. Priority Date: 07/22/1995
• Status: Expired due to Fees

• Current Assignee: Labtec Gesellschaft Fur Technologische Forschung Und Entwicklung Mbh
• Original Assignee: Labtec Gesellschaft Fur Technologische Forschung Und Entwicklung Mbh
• Inventors: Siegmund, Martin, Cordes, Guenter
• Primary Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US09/010,534
• Time in Patent Office: 663 Days
• Field of Search: 424/448, 514/946, 514/947
• US Class Current: 424/428
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• 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 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 9/7061 Polyacrylates

Abstract

A transdermal therapeutic system (TTS) which contains as the active ingredients an oestrogen and a gestagen or a gestagen or androgen as well as an acrylate adhesive and, as resorption promoters, the two substances oleic acid and 2-(2-ethoxyethoxy)ethanol.

Claims

1. A transdermal therapeutic system which comprises;

A. a backing film;

B. a coating on the backing film which comprises;

(i) an acrylate-based pressure-sensitive adhesive;

(ii) a hormone selected from the group consisting of oestrogen, androgen and gestagen; and

(iii) a resorption accelerator comprising a mixture of oleic acid and 2-(2-ethoxyethoxy)-ethanol wherein the mixture has been incorporated in an amount of 1 to 10 percent by weight of the system excluding the weight of the backing film plus the weight of the releasable protective film, and wherein the oleic acid and 2-(2-ethoxyethoxy)-ethanol have been incorporated with a ratio by weight of 2;

1 to 1;

2; and

C. a releasable protective film over the coating.

2. A transdermal therapeutic system according to claim 1, wherein the oestrogen is selected from the group consisting of oestradiol and ethinyl oestradiol, the gestagen is selected from the group consisting of norethisterone acetate, levonorgestrel, progesterone and chlormadinone acetate, and the androgen is testosterone, said hormones being in the form of a base or their pharmaceutically acceptable salts and esters.

3. A transdermal therapeutic system according to claim 1 wherein the acrylate-based pressure-sensitive adhesive has been obtained by radical polymerization of a compound selected from the group consisting of butyl acrylate, 2-ethylhexyl acrylate, methylacrylate, vinyl acetate, acrylic acid, and hydroxyethyl acrylate.

4. A transdermal therapeutic system according to claim 3, wherein the oleic acid 2-(2-ethoxyethoxy) ethanol have been incorporated in a ratio of 1.5:

1 to 1;

1.5.

5. A transdermal therapeutic system according to claim 1, wherein the hormone selected is oestradiol and norethisterone acetate.

6. A transdermal therapeutic system according to claim 1, wherein the hormone selected is oestradiol and levonorgestrel.

7. A transdermal therapeutic system according to claim 1, wherein the hormone selected is ethinyl oestradiol and levonorgestrel.

8. A transdermal therapeutic system according to claim 1, wherein the androgen is testosterone.