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Review Article Open Access

Quality by Design (QbD) Approach for Formulation Development and Evaluation of Fixed-Dose Combination Tablets: A Comprehensive Review


Quality by Design (QbD) is a systematic approach to developing, producing, and controlling pharmaceutical products that emphasize understanding and controlling the Critical Quality Attributes (CQAs) of the product and process. QbD helps to ensure that a product meets its intended quality and performance characteristics and can help to identify and prevent potential manufacturing problems. Instead of providing quality through product testing, QbD aims to ensure pharmaceutical quality by incorporating quality into the products from the start. The purpose of this current study is to provide an overview of the QbD approach for formulation development and evaluation of Fixed Dose Combination (FDC) tablets. The paper further covered dosage forms, fixed dose combination drugs, and the principles and elements of pharmaceutical quality by design. It also examined the distinctions between Quality by Testing (QbT) and Quality by Design (QbD). The article discussed QbD tools, the evaluation of FDC tablets, and the challenges of the QbD approach in pharmaceutical development. The goal of pharmaceutical development is to create high quality products, and the manufacturing process should be carefully planned to ensure that the product performs consistently as expected.

Simon Nyarko

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