Crystalline rotigotine base and preparation process therefor

Abstract

An isolated and pure crystalline rotigotine base of polymorph Form I, and processes for producing the crystalline rotigotine base are disclosed. Also disclosed is a transdermal patch for the delivery of rotigotine base using the disclosed isolated and pure form of rotigotine base, which can be used in treatment of Parkinson's Disease and other disorders ameliorated or treated by rotigotine, including restless leg syndrome.

What is claimed is: 
     
         1 . Solid rotigotine base. 
     
     
         2 . The solid rotigotine base of  claim 1 , which is in crystalline form, having X-ray powder diffraction pattern comprising peaks at 14.6, 15.2, 15.6, 16.6, 17.0, 19.7, 20.2, 22.6 and 27.8 degrees 2θ. 
     
     
         3 . The crystalline rotigotine base of  claim 2  having an infrared spectrum comprising absorption peaks at 1583±4, 1466±4, 1377±4, 1281±4, 1203±4, 1080±4, 1011±4, 881±4, 775±4, and 700±4 cm −1 . 
     
     
         4 . The crystalline rotigotine base of  claim 2  having a melting point of about 75° C. to about 77° C. 
     
     
         5 . The crystalline rotigotine base of  claim 2  having a differential scanning calorimetry curve comprising a peak onset at about 75±1° C. 
     
     
         6 . The crystalline rotigotine base of  claim 2  having a purity of at least about 98.5%. 
     
     
         7 . The crystalline rotigotine base of  claim 6  having a purity of at least about 99.5%.