DESIGN AND OPTIMIZATION OF SUSTAINED RELEASE MATRIX TABLET OF OPIPRAMOL HCL BY USING QUALITY BY DESIGN APPROACH
Abstract
Quality by Design (QbD) refers to an advance approach towards drug development. Quality by design 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 quality by design. The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) for formulation development with a case study of sustained release tablet of Opipramol. The QbD means designing and developing formulations to ensure predefined product quality. The study describe elements of the QbD for Opipramol sustained release tablet, include: Defining Quality target product profile, Identifying critical quality attributes, establishing design space, control strategy. Sustained release tablet of Opipramolwere prepared by dry granulation using HPMC K4M and level of polymer was optimized, factorial design was used as part of risk analysis to optimize level of other excipients. Invivo study of optimizes formulation was done in animals and it was correlated with in vitro drug release study (IVIVC).
The optimized formulation could able to release the drug for 24 hrs making once a daily tablet, Design space for polymer was determined to be (10 to 15%), level of flow property enhancer () and hardness of 4-5 which ensure extended drug release. The IVIVC shown level A correlation (R2 = 0.996).Thus work facilitates the adoption and implementation of QbD for formulation development using QbD and could increase efficiencies, provide regulatory support, flexibility and pharmaceutical quality is assured by understanding and controlling formulation variables.
Keywords: QbD, Sustain Release, Opipramol HCl, Risk assessment
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