Transdermal therapeutic system for parkinson's disease inducing high plasma levels of rotigotine

• US 20030026830A1
• Filed: 05/07/2002
• Published: 02/06/2003
• Est. Priority Date: 05/08/2001
• Status: Abandoned Application

• Current Assignee: LTS Lohmann Therapie-Systeme AG, UCB Pharma GmbH (UCB SA)
• Original Assignee: UCB Pharma GmbH (UCB SA)
• Inventors: Lauterback, Thomas, Muller, Walter, Wolff, Hans-Michael, Schacht, Dietrich Wilhelm
• Application Number:
  US10/140,096
• Publication Number:
  US 20030026830A1
• Time in Patent Office: Days
• US Class Current: 424/449
• CPC Class Codes: A61K 31/381 having five-membered rings

Abstract

This invention provides the use of a silicone-based transdermal therapeutic system having an area of 10 to 40 cm² and containing 0.1 to 3.15 mg/cm² of rotigotine as active ingredient, for the preparation of an anti-Parkinson medicament which induces a mean plasma concentration of rotigotine in the range of 0.4 to 2 ng/ml 24 h after administration.

Claims

1. The use of a silicone-based transdermal therapeutic system having an area of 10 to 40 cm² and containing 0.1 to 3.15 mg/cm² of rotigotine as active ingredient, for the preparation of an anti-Parkinson medicament which induces a mean plasma concentration of rotigotine in the range of 0.4 to 2 ng/ml 24 h after administration.

2. The use according to claim 1 wherein the silicone-based transdermal therapeutic system comprises two or more silicone adhesives as the main adhesive components.

3. The use according to claim 1 or 2 wherein the silicone-based transdermal therapeutic system further includes a solubilizer.

4. The use according to claim 3 wherein the solubilizer is polyvinylpyrrolidone.

5. The use according to any of the preceding claims wherein the silicone-based transdermal therapeutic system contains less than 1 wt % of inorganic silicates.

6. The use according to claim 5 wherein the silicone-based transdermal therapeutic system is free from inorganic silicates.

7. The use according to any of the preceding claims wherein the transdermal therapeutic system has an area of 10 to 30 cm².

8. The use according to any of the preceding claims wherein the transdermal therapeutic system contains 0.1 to 1.5 mg/cm² of rotigotine.

9. The use according to claim 1 wherein the transdermal therapeutic system is a patch having an area of 10 to 30 cm² and a content of rotigotine of 0.4 to 0.5 mg/cm² in an adhesive silicone-based matrix.

10. The use according to any of the preceding claims wherein the mean plasma concentration of rotigotine in the range of 0.4 to 2 ng/ml is maintained for at least 14 days upon continuous further administration of said transdermal therapeutic system.

11. A method of treating Parkinson'"'"'s Disease by applying on a patient suffering from this disease a silicone-based transdermal therapeutic system having an area of 10 to 40 cm² and containing 0.1 to 3.15 mg/cm² of rotigotine as active ingredient, wherein said transdermal therapeutic system induces a mean plasma concentration of rotigotine in the range of 0.4 to 2 ng/ml 24 h after administration.