Journal of Pharmaceutical Chemistry and Drug formulation ISSN: 3108-0782 (Online)

Authors: Anjali Rao, Dr. Kiran Mehta

Abstract: Quality by Design (QbD) is a systematic approach to pharmaceutical development that emphasizes predefined objectives, process understanding, and control strategies. The QbD framework enhances the development of oral solid dosage forms by ensuring consistent quality, safety, and efficacy. This paper focuses on the application of QbD principles in formulation optimization, highlighting the identification of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and the design space. Risk assessment tools such as Failure Mode and Effects Analysis (FMEA) and Ishikawa diagrams guide experimental design. Design of Experiments (DoE) is employed to study the effect of formulation variables on tablet properties including hardness, friability, dissolution, and content uniformity. The study evaluates the impact of excipient selection, granulation method, and compression force on formulation performance. A representative table summarizes the influence of key factors on critical quality attributes. Results demonstrate that QbD-based formulation optimization improves process robustness, reduces batch-to-batch variability, and facilitates regulatory compliance. This approach provides a scientific framework for efficient, reproducible, and high-quality oral solid dosage form development.

Keywords: Quality by Design, oral solid dosage forms, formulation optimization, Critical Quality Attributes, Critical Process Parameters, Design of Experiments, process robustness