Abstract

DESIGN OF EXPERIMENT: A NOVEL AND SYSTEMATIC APPROACH OF DEVELOPING FORMULATIONS IN PHARMACEUTICALS

Mahima Mathur and V. Kusumdevi*

Abstract

Quality by design (QbD) is a new modern perspective towards the qualitative pharmaceutical development. Many pharmaceutical companies have used several Quality Management System (QMS) for instance ISO 9001. This is a systematic approach to design and develop the pharmaceutical formulations and manufacturing processes that ensures the predefined product quality. In order to achieve this, DoE should be adopted, which confirms a structured and organized method for determining the relationships among factors affecting a process and its output. A DOE evaluates effects of the design factors on manufacturability and Critical Quality Attributes (CQAs) of the final product, thereby establishing a design space to validate desired CQAs, which includes critical material and process parameters. It has been suggested that DoE can offer returns that are four to eight times greater than the cost of running the experiments in a fraction of time when compared to one-factor-at-a-time (OFAT) experiments. In the present review, the authors have reviewed various design of experiments required for the screening and optimization of the various factors. They have mentioned that it also helps to indicate the various resources and assists in managing expectations from a study‟s outcome. DoE studies in support of QbD are often a delicate balance between delivering defined, high-quality products and meeting predetermined time, labor, and financial constraints.

Keywords: Quality by design (QbD), Design of experiment (DoE), Process analytical technologies (PAT), One factor at a time (OFAT), Quality risk management (QRM), Critical process parameters (CPP), Analysis of variance (ANOVA).