1N.Venkatesh*, 1K.Spandana, 2U.Sambamoorthy, 3K.Suresh
1SARC – (Scientific and Applied Research Center) Hyderabad, India
2Sana College of Pharmacy, Kodad, India
3Pratishta Institute of Pharmaceutical Sciences, Durajpally, Suryapet, India
Statins are the most commonly prescribed lipid lowering agents because of their effectiveness, tolerability and ease of administration. Rosuvastatin calcium is synthetic lipid lowering agent which inhibits 3-hydroxy-3-methyl-glutaryl co-enzyme-A reductase, preventing the conversion of HMG-CoA to Mevolanate. Its absolute bioavailability is 14% and coming under the class II of biopharmaceutical classification system. To enhance the solubility of Rosuvastatin cyclodextrin complexation techniques was employed. Phase solubility studies were carried out to optimize the ratio of complexing agent with drug. Drug with MβCD found to increase the solubility maximum extent evident from the higher Ks value. Further formulation prepared by spray drying displayed maximum solubility and improved release rate. Characterization such as FTIR, SEM, DSC has been found to be satisfactory. Optimized formulation was directly compressed with superdisintegrants into fast dispersible formulations, which showed immediate disintegration and faster rate of drug release compared to marketed formulation with L-HPC being optimum. Thus a fast dispersible tablet of Rosuvastatin was formulated using cyclodextrin complex resulted in enhanced solubility and faster disintegration and immediate release rate.
Keywords: Rosuvastatin, cyclodextrin and fast dispersible tablet.