QUALITY BY DESIGN APPROACH TO OPTIMIZE OSMOTICALLY CONTROLLED DRUG DELIVERY SYSTEM

The present investigation deals with the development of the controlled porosity osmotic pump (CPOP) tablet of Garcinia indica fruit rind extract used in the management of colon cancer by implementing the concept of Quality by Design (QbD). The quality target product profile (QTPP) and Critical Quality Attributes (CQA) of the Garcinia indica tablets were defined based on preliminary studies. The effects of critical parameters were investigated by executing the design of experimentation (DOE) using 3² factorial design. The inclusion complexes of Garcinia indica and HP-βCD were added with an optimized amount of sodium chloride in the core of the tablet and coated with cellulose acetate. Multiple regression analysis and ANOVA were employed to identify and to estimate the effect of important parameters and establish their relationship with CQAs. The results of multiple linear regression analysis revealed that CPOP tablets should be prepared using an optimum % weight gain of the tablet (X1) and concentration of pore-forming agents in the coating (X2) to achieve a zero-order drug release. The contour plot suggests that independent variables X1 and X2 were found by 10.6% and 7.2 gm. respectively, for a maximized response. The drug release was inversely proportional to the membrane weight but directly related to the initial level of pore former in the membrane. The study indicated that the feasibility of extending the zero-order release pattern of Garcinia indica fruit rind extract was better achieved with controlled porosity osmotic pump tablet for the treatment of colon cancer.