Pharmaceutical composition comprising rotigotine salts (acid or Na), especially for iontophoresis

摘要

The present invention relates to new salts of 6-(propyl-(2-thiophen-2-ylethyl)amino)tetralin-1-ol(rotigotine), their use as a medicament, for example for the treatment of CNS disorders like Parkinson Disease, RLS, fibromyalgia and/or depression, in particular through electromotive administration. The present invention relates to pharmaceutical formulations suitable for iontophoresis that provide enhanced iontophoretic delivery of rotigotine to at least one target tissue. The formulations are further characterized by good to excellent solubility of the salts in aqueous solutions.

主权项

1. A pharmaceutical formulation comprising at least one pharmaceutically acceptable acid addition salt of 6-(propyl-(2-thiophen-2-ylethyl)amino)tetralin-1-ol(rotigotine) and optionally a pharmaceutically acceptable electrolyte wherein said rotigotine salt has a saturation solubility in an aqueous solution which is at least 16 μmol/ml at a pH<6 and/or at least 30 μmol/ml at a pH≦5, wherein the saturation solubility is calculated based on the total amount of rotigotine in the pharmaceutically acceptable acid addition salt with the proviso that said salt is not rotigotine.HCl.