ABSTRACT:
Rosuvastatin is a statin medication used to prevent cardiovascular disease in those patients who are at high risk and also to treat abnormal lipids. Rosuvastatin is a HMG-Co-A inhibitor used for the treatment of hyperlipidemia and atherosclerosis disease. The main objective of the study was to prepare Rosuvastatin Mouth Dissolving Films. The absolute oral bioavailability of rosuvastatin is found to be 20% due to its extensive first pass effect after oral dosing. Rosuvastatin Mouth Dissolving Films are prepared with a combination of hydrophilic polymers like HPMC, Lycoat and HEC with superdisintegrants CCS and SSG. PEG 400 was used as a plasticizer. Citric acid was used as a saliva stimulating agent. All the films are prepared with different drug polymer ratios to study the effect of weight fraction of carrier on dissolution rate of the drug. The films readily dissolved in the dissolution medium. In-vitro parameters like thickness, disintegration, folding endurance, assay, weight of the films, % elongation of the films were evaluated for all the 15 formulations. The drug release profiles of the drug from the films were investigated. Preformulation studies like compatability studies with polymers using FTIR, DSC, XRD and SEM studies were carried out. The drug and the polymers were found to be compatible with each other. The release of the Rosuvastatin from the films was found to be 98.74% in 20min in the dissolution medium (pH 6.8 phosphate buffers). The drug release profiles of the films were analyzed using UV-visible spectrophotometer at 246nm. The prepared 15 formulations of rosuvastatin were also evaluated for percentage drug release at various time intervals. The results are shown that ROS 2 formulation was best in terms of drug content and drug release.