Abstract

FORMULATION AND EVALUATION OF BUCCAL FILM OF ROSUVASTATIN

Shivani Saxena* and Dr. Sobhna Singh

ABSTRACT

For systemic drug delivery, the buccal region offers an attractive route for drug administration. The main objective of the study is to formulate buccal films of rosuvastatin. Rosuvastatin is a HMG Co-A inhibitor used for the treatment of hyperlipidaemia, atherosclerosis disease. It’s oral bioavailability is 20% due to extensive first pass metabolism. Rosuvastatin films were prepared using HPMC, CMC and PVA, Tragacanth in various proportions and combinations using Glycerine as a plasticizer. Citric acid was used to enhance the penetration of buccal film. The surface pH of films ranged between 6 and 7. The thickness of medicated patches was ranged between 0.24 and 0.39 mm. The tensilestrength of all films was varied from 0.90 to 1.49kg/mm2. All formulations showed folding endurance more than 300.The results of drug contents showed that there is enough amount of drug is present in the films which varied from 69.75 to 72.29%. The swelling index for all formulations was varied from 41.75 to 50.91%. The prepared 7 films of rosuvastatin were also evaluated for percentage drug release at various time intervals in simulated saliva fluid. The results are shown that F3 formulation was best for drug content and drug release. Data of in vitro release from films were fitted to different kinetic models such as zero order, first order, Higuchi and Korsmeyer–Peppas models to explain the release profile. Formulations F9 was observed best fitted to Higuchi model.

Keywords: HPMC, CMC, PVA, Tragacanth (polymers), Buccal film, Hyperlipidaemia, Atherosclerosis, Rosuvastatin.