Original Articles: 2010 Vol: 2 Issue: 2
Once a day osmotic drug delivery system for highly water soluble Pramipexole
Abstract
An oral monolithic osmotic system for highly water-soluble pramipexole dihydrochloride monohydrate has been developed and characterized. Monolithic osmotic system was developed using controlled porosity membrane, this system delivers drug in controlled manner for prolonged period of time. Controlled porosity osmotic membrane consists of cellulose acetate as coating polymer and water-soluble pore formers, which forms an in-situ microporous membrane after imbibing water, hence no laser drilling is required. Pore formation was controlled by varying concentration of pore forming agents to get controlled release of pramipexole for period of 24 hrs. Scanning electron microscopy was carried out to confirm the microporous structure. An optimized system was selected to study the effect of different concentration of coating polymer, osmotic agents, pH of dissolution media and effect of agitation on the release of drug. From in vitro release studies it was evident that drug release was independent of pH and agitation but highly dependent on concentration of pore forming agents used. Increasing concentration of cellulose acetate from 2 % - 5 % w/v drastically retarded drug release. Osmotic pressure generated was determined using 3D3 Freezing point osmometer and was found to be linear with drug release. The developed formulation gave desired once a day release of pramipexole without using laser drilling technique making it more patient compliance and cost effective.