Formulation and Evaluation of Baclofen Controlled Porosity Osmotic Pump Tablets

Abstract

In the present study, attempts were made to develop and evaluate the controlled porosity osmotic pump (CPOP) based drug delivery system of sparingly water soluble drug Baclofen. Formulation variables, such as, levels of solubility enhancer, ratio of drug to osmogents, coat thickness of semi permeable membrane (SPM) and level of pore former were found to affect the drug release from the developed formulations. Cellulose acetate was used as the semi permeable membrane. Drug release was directly proportional to the level of the solubility enhancer, osmotic pressure generated by osmotic agent and level of pore former; however, was inversely proportional to the coat thickness of SPM. Drug release from developed formulations was independent of pH and agitation intensities of release media. Burst strength of the exhausted shells decreased with increase in the level of pore former. This system was found to deliver Baclofen at a zero-order rate. The optimized formulations were subjected to stability studies as per ICH guidelines, and formulations were found to be stable after 45days study.