Fabrication of Extended Release Tablets of Pramipexole: In-vitro Studies

摘要

In this study, Extended release (ER) tablets of Pramipexole (PMPL) to be taken once daily were prepared and evaluated. Formulations were developed using different polymers and excipients in varying concentrations to get the desired extended release period of 24 h. The granules were prepared by wet granulation method and evaluated for angle of repose (AR), bulk density (BD), tapped density (TD), Carr’s index (CI) and Hausner’s ratio (HR). The granules showed satisfactory flow properties. The compressed tablets were evaluated for weight variation, hardness, friability, drug content, thickness and in-vitro drug release. Formulation (F9) containing Sodium carboxy methyl cellulose (SCMC- 10%) and both grades of Micro Crystalline Cellulose (MCC PH101, MCC PH102) as diluents gave the desired release for once a day administration. The drug release was found to be followed first order kinetics and particularly diffusion with non-fickian transport mechanism. In-vitro release pattern of drug from the optimized formulation F9 was found to be similar (i.e. the similarity factor f2 was found to be 66.43) with the marketed product MIRAPEX ER and showed better drug release pattern than the marketed product. It was revealed from the results that the formulation F9 could be the suitable candidate for the effective treatment of Parkinson’s disease as once daily formulation.