Design and Evaluation of Fast Disintegrating Tablets of Taste-Masked Drotaverine Hydrochloride Using Polyvinyl Pyrrolidone.

The purpose of this study was to prepare and evaluate a taste-masked drotaverine hydrochloride fast disintegrating tablet to prevent bitter taste of the drug and for increase in drug release. The drug was characterized according to different compendial methods, on the basis of identification by UV spectroscopy, IR, organoleptic properties and other tests. Taste masking was performed by coating drotaverine hydrochloride with polyvinyl pyrrolidone (PVP) using a solvent evaporation technique. Among the different ratios of drug:polymer,1:1 was selected for further studies because of high drug loading capacity (75%) and good mouth feel effect. The granules of optimized drug-polymer complexes (DPCs) were tested for packing and flow properties. These granules were compressed into tablets and evaluated for hardness, friability, drug content, wetting time, in vitro disintegration time and in vitro taste in simulated salivary fluid (SSF) of pH 6.2. The Superdisintegrant CCS (crosscarmellose sodium) and crospovidone were used for immediate release of drug from tablet. The granules of the optimized DPCs were free flowing with angle of repose<30°. These tablets disintegrated rapidly (<68sec) with a wetting time of ≤24sec. It also showed rapid drug release in stimulated gastric fluid (SGF) within 6 min up to 92%. This study shows the suitability of PVP polymers SSG, CCS superdisintegrant in masking the bitter taste and rapid release of drotaverine HCl.