FORMULATION DEVELOPMENT OF DONEPEZIL HYDROCHLORIDE ORAL DISINTEGRATING TABLETS USING QUALITY BY DESIGN APPROACH

摘要

This study posed a challenge for the risk management to research and development projects in a highly regulated and volatile pharmaceutical industry, in which projects are extremely long, complex, costly and prone to failure. Project management in new product development, must be efficient and effective. This emphasizes the importance of risk management. Quality by design (QbD) refers to an advanced approach toward drug development. QbD is a vital part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of QbD. The purpose of this research was to discuss the pharmaceutical QbD for formulation development with a case study of Orally Disintegrating Tablet (ODT) of Donepezil Hydrochloride (DPH). The study describes elements of the QbD for DPH ODT, include: Defining quality target product profile, identifying critical quality attributes, establishing design space, control strategy. ODT of DPH was prepared by direct compression method using Crospovidone, MCC and level of polymer was optimized, factorial design was used as part of risk analysis to optimize the level of other excipients. Thus, the work facilitates the adoption and implementation of QbD for formulation development using QbD and could increase efficiencies, provide regulatory support