FORMULATION AND OPTIMIZATION OF MOUTH DISSOLVING FILM OF ROSUVASTATIN CALCIUM USING QBD APPROACH

Abstract

The aim of the present study was to design the mouth dissolving film of Rosuvastatin calcium (RC) by applying quality by design (QbD) approach. The mouth dissolving film was prepared using solvent casting method. The critical quality attributes (CQAs) and quality target product profiles (QTPP) of RC mouth dissolving films were defined based on previous studies. Plackett-Burman experimental design was used for initial screening of process and formulation variables. The screened variables were further optimized using 3² full factorial designs. The variables influencing formulation of film was HPMC E5 and PVP K30. The design space was determined using statistical tool and optimized formulations were prepared within the design space. The optimized films showed all the evaluation parameters within the QTPP. The results indicated that as long as formulation variables remain within the design space, mouth dissolving film of RC with desired characteristics and quality requirement could be formulated.