Formulation and Evaluation of Micro Balloons of Domperidone

摘要

The present study on the manufacturing of Microballons of Domperidone elaborates various steps taken during the development and manufacturing of microballoons keeping in constant knowledge of quality by design guidelines. The importance of target product profile and critical quality attributes which results in the finalization of product design have been demonstrated in the present work. Every steps were taken after due consideration of risk evolved by virtue of prior technical knowledge and experimentation. In the product design space the product characterization involved critical quality attributes which ultimately leads to critical process parameters that are design space. Control strategies for continuous monitoring process and product have also been recommended. Critical process parameters were also validated to achieve and monitor the quality of final product. The CPP has direct impact on critical quality attributes hence these parameters were develop with proper tolerances. The QbD principle demonstrated in present research will play an important role in the understanding and creating opportunities for investigation and control strategy in formulation.