| 摘要 |
Disclosed is a rotigotine drug substance comprising at least 5% of a polymorphic form (II) of rotigotine ((-)-5,6,7,8-tetrahydro-6-[propyl-[2-(2-thienyl)ethyl]-amino]-1-naphthalenol) having at least one of: a X-ray powder diffraction spectrum comprising at least one peak at the following °2q angles (± 0.2): 12.04, 13.68, 17.72, 19.01; a Raman spectrum comprising at least three peaks at the following wave numbers (± 3 cm-1): 226.2, 297.0, 363.9, 710.0, 737.3, 743.3, 750.8, 847.3, 878.3, 1018.7, 1075.6, 1086.2, 1214.3, 1255.1, 1278.2, 1330.7, 1354.3, and 1448.7; a DSC peak with a Tonset at 97oC ± 2°C measured with a heating rate of 10oC/min; a melting point of 97oC ± 2°C. Also disclosed is a pharmaceutical composition which comprises a rotigotine drug substance as defined above, and at least one pharmaceutically acceptable excipient, for the treatment of a patient suffering from a disease sensitive to the treatment with D2 receptor agonists, wherein said disease is selected from Parkinson's Disease, Parkinson's plus syndrome, depression, fibromyalgia, restless-legs syndrome, and/or dopaminergic neuron loss.
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