Development of Pramipexole Prolonged-Release Matrix Tablets

Abstract

The present work deals with the development of a prolonged release matrix tablet of the readily soluble drug pramipexole. The new excipient Kollidon SR (a mixture of 80% polyvinyl acetate and 20% polyvinylpyrrolidone) and hypromellose K15M were used as polymers to control drug release from selected prototypes. Various polymer concentrations were tested to achieve a stable and pH independent release of pramipexole of 0.26 mg over 24 hours; samples were prepared by wet granulation and compression of matrix tablets. Drug release was monitored in dissolution media with pH values from 1.2 to 6.8 and compared with a reference product based on a hydrophilic matrix with a combination of three different polymers. The required release profile of the low-dose drug formulation was achieved using 60.0% (w/w) of Kollidon SR in all dissolution media and the selected formulation F2 demonstrated a sufficient alcohol resistance up to the ethanol concentration of 40% (v/v).