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Process development, evaluation and controlling of parameters during formulation development of Loratadine as an ODT by QBD concept

Volume No : (2015) Volume: 03 Issue : 20 Year : 2015 Page No: 727-749

Authors : Biswajit Bunia, Swati Rawat

Abstract :

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 paper was to discuss the pharmaceutical QbD for formulation development with a case study of oral disintegrated tablets (ODT) of Loratadine. The QbD means designing and developing formulations to ensure predefined product quality. The study describes elements of the QbD for Loratadine ODT, include: Defining quality target product profile, identifying critical quality attributes, establishing design space, control strategy. Loratadine ODT was prepared by wet granulation using microcrystalline cellulose USNF and level of other components were optimized, factorial design was used as part of risk analysis to optimize the level of other excipients with hardness of 2-5 KPa. The study concluded thethe 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.

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