Original Articles
Jitendra Singh Rajawat, Mahend
Abstract
The present investigation deals with preparation of bi-layer tablets of model drug atorvastatin calcium(ATC) and ramipril (RA) and to determine the influence of the certain excipients on physical properties of the tablet. Wet granulation technique was used because of its ease of access and contains limited number of unit operations. Ac-disol and PVP K30 were used as disintegrant and binder respectively. Employing a 32 factorial design, the joint influence of two formulation variables like disintegration time and percent drug release were determined. The drug excipient compatibility studies were performed by physical observation and DSC. The multiple linear regression analysis was used to find the effect of these variables on physical properties of final formulation. Finally, a checkpoint batch is prepared to prove the validity of evolved method. Using the contour plot, effect of the independent variables on the responses was represented graphically. The stability studies of the optimized formula were carried as per ICH guidelines.