Formulation and evaluation of mucoadhesive sublingual tablet of rosuvastatin calcium
Rosuvastatin calcium is a lipid lowering agent whic h has been selected as a model drug for investigati on, because of its very low bioavailability (20% due to extensive first pass metabolism. In this work a new attempt was made to enhance the solubility, dissolution rate and oral b ioavailability of poorly soluble rosuvastatin calci um by formulating it as direct compression method by usin g mucoadhesive polymer chitosan and various super disintegrant like sodium starch glycolate and crosc armelose sodium. Solubility of rosuvastatin calcium ncreased by using complexing agent b cyclodextrin by kneading method. Mucoadhesive subl ingual tablet were evaluated by pre and poss comprssion parameter. Precompression test lik bulk density, tap density, angle of repose, ca rs index and postcompression test include thickness, hardness, f riability, weight variation, drug content, disinteg ration time, wetting time, surface pH, in vitro drug release and ex vivo mucoadhesive time. USP II type appraratus is used for measuring mucoadhesion time with fresh got mucus me mbrane. The order of drug release from the dosage f orm has been determined. The optimized formulation followed Hixon Crowel kinetics release. The physiochemical interaction between the drug and polymer were inves tigated using FTIR and DSC study.Optimized formulat ion (F4) showed 96.69% in vitro release within 60 min. The p resent study concluded that sublingual delivery of mucoadesive rosuvastatin calcium tablets can be a good way to b ypass the first pass metabolism and it will render great bio availability.