Formulation And Evaluation Of Captopril Sustained Release Tablet By Qbd Approach.

Abstract

The purpose of present study was to formulation and evaluation of Captopril sustained release tablet by QbD approach using size expanding polymer and cross linker. Captopril is a ACE inhibitor use in treatment of mild to moderate hypertension. Captopril having biological half-life of 2 hrs. The drugs gets degrade as its goes to higher pH, so we selected size expanding GRDDS.  In formulation development study by using QbD, we found that the critical quality attributes affecting final drug product are swelling index, Q8 (%) and T90 (hrs). They were further categorized base in their risk level by risk assessment as high, medium and low level. After that particular control strategy apply in order to control risk and reduced level from high to low, medium to low then after justification was given for update risk assessment and optimized batch was prepared and evaluated. The three-level, three factorial Box-Behnken experimental designs was adopted. Design-Expert 8.0.7.1 was used for generating mathematical equations and inferring the statistical significance of one model over the other. The results shown that the optimized formulation containing xanthan gum (250 mg) , ethyl cellulose (70 mg) and calcium chloride (137 mg) shown the better swelling index (364.45), Q8 (38.51), and T90 (21 hrs 6 min). From results it concluded that this study demonstrated that the QBD is a potential Paradigm for understanding the quality and optimizing the formulation and process by using implementation of QBD approach.