Abstract

Application of Quality by Design (QbD) Approach In Formulation of Oral Delayed Release Tablet of Lansoprazole

Gayatri Patel, Associate professor, Ramanbhai Patel College of Pharmacy

The present investigation was aimed to design and optimize the oral delayed release tablet with a view of providing stability and desired dissolution of Lansoprazole. Quality by Design (QbD) principles were used to identify and control critical sources of variability in the process and to understand the impact of Critical material attributes (CMAs) & Critical Process Parameters (CPPs) on the Critical Quality Attributes (CQAs) during product development. For formulation development, slugging method was selected due to moisture instability of drug. Excipients selection was done using prior experience, drug excipients compatibility studies and preliminary trials. The present study confirmed the use of risk assessment tool along with experimental design in understanding the effect of the drug substance and excipients attributes and process parameters on the quality of final product. Screening design and factorial design were used for optimization of final product. From regression analysis and design space obtained, optimum batch was selected. The optimum batch was further evaluated and characterized by FTIR and P-XRD. Accelerated stability study was performed on optimized batch for a period of 6 months. In conclusion, this study demonstrated the application of QbD principle in the stable formulation of oral delayed release tablet of Lansoprazole.