Iontophoretic delivery of rotigotine for the treatment of Parkinson's disease

• US 7,632,859 B2
• Filed: 11/17/2003
• Issued: 12/15/2009
• Est. Priority Date: 12/02/2002
• Status: Expired due to Fees

• Current Assignee: UCB Pharma GmbH (UCB SA)
• Original Assignee: Schwarz Pharma Ag (Schwarz Pharma)
• Inventors: Bouwstra, Johanna Aaltje, Nugroho, Akhmad Karis, Li, Gai Ling, Wolff, Hans-Michael
• Primary Examiner(s): Padmanabhan; Sreeni
• Assistant Examiner(s): CLAYTOR, DEIRDRE RENEE
• Application Number:
  US10/713,424
• Publication Number:
  US 20040116537A1
• Time in Patent Office: 2,220 Days
• Field of Search: 514/438
• US Class Current: 514/438
• CPC Class Codes: A61K 31/381 having five-membered rings
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs

Abstract

By using a composition comprising rotigotine and at least one chloride salt in a concentration of 1 to 140 mmol/l, the composition having a pH of 4 to 6.5 in a iontophoretic device for the treatment of Parkinson'"'"'s disease, it became possible to obtain a rotigotine flux across the human stratum corneum which was higher than the one previously obtained with conventional passive diffusion systems.

Claims

1. A method for treatment of Parkinson'"'"'s disease comprising applying an iontophoretic device, which comprises a composition comprising (a) rotigotine in a concentration sufficient to provide a therapeutically effective rotigotine flux for treatment of Parkinson'"'"'s disease, and (b) at least one chloride salt selected from the group consisting of triethylammonium chloride, tributylammonium chloride and combinations thereof in a concentration of 1 to 140 mmol/l, the composition having a pH of 4 to 6.5, onto skin of a patient in need thereof.

2. The method of claim 1, wherein the concentration of rotigotine in the composition is at least 0.5 mg/ml.

3. The method of claim 1, wherein the concentration of rotigotine in the composition is 0.5 to 3 mg/ml.

4. The method of claim 1, wherein the concentration of the chloride salt is 60 to 80 mmol/l.

5. The method of claim 1, wherein the composition forms a donor phase of the iontophoretic device.

6. The method of claim 5, wherein the composition forming the donor phase of the iontophoretic device comprises rotigotine in a concentration of 0.5 to 3 mg/ml and at least one of triethylanimonium chloride and tributylanimonium chloride in a concentration of 60 to 80 mmol/l, and wherein the pH of the donor phase is 4.5 to 5.5.

7. A method for treatment of Parkinson'"'"'s disease comprising applying an iontophoretic device, which comprises a composition comprising (a) rotigotine in a concentration sufficient to provide a therapeutically effective rotigotine flux for treatment of Parkinson'"'"'s disease, and (b) at least one pharmaceutically accentable chloride salt in a concentration of 1 to 140 mmol/l, the composition having a pH of 4 to 6.5, onto skin of a patient in need thereof.

8. The method of claim 7, wherein the concentration of rotigotine in the composition is at least 0.5 mg/ml.

9. The method of claim 7, wherein the concentration of rotigotine in the composition is 0.5 to 3 mg/ml.

10. The method of claim 7, wherein the at least one chloride salt is selected from NaCl, triethylanimonium chloride and tributylammonium chloride.

11. The method of claim 7, wherein the concentration of the chloride salt is 60 to 80 mmol/l.

12. The method of claim 7, wherein the composition forms a donor phase of the iontophoretic device.