Abstract

QUALTY BY DESIGN IN THE FORMULATION AND DEVELOPMENT OF DOSAGE FORMS

Amrutha O.* and Shijith K. V.

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Abstract

In this era the application of quality by design in pharmaceutical development has gained greater importance. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. Among various mathematical modeling approaches, Design of Experiments (DoE) is widely applied for the implementation of QbD in both research and industrial settings. In QbD, product and process understanding are the key that enables the assurance of quality in the final product. Knowledge is achieved by establishing models correlating the inputs with the outputs of the process. By establishing mathematical relationship between Critical Process Parameters (CPPs) and Material Attributes (CMAs) with the Critical Quality Attributes (CQAs), a design space is defined. Consequently, the process understanding is well assured and rationally leads to a final product that meets the Quality Target Product Profile (QTPP). It is important to recognize that quality cannot be tested into products, i.e., quality should be built in by design. The prime objective of QbD is to generate quality and safety employing very first design steps. This review details the concept of pharmaceutical quality by design (QbD), steps of implementing QbD and their salient features.

Keywords: Quality target product profile, Critical quality attributes, Critical material attributes, Critical process parameters, Control strategy, DoE.