A Review on the Application of Quality by Design Methodology in the Formulation, Development, and Evaluation of Fixed-Dose Combination Tablets

Quality by Design (QbD) is a systematic approach used to develop, produce, and control high-quality products. The review article aims to provide a concise overview of the QbD approach employed in the formulation, development, and evaluation of Fixed-Dose Combination (FDC) tablets. This will buttress on the essence of the usage of this approach by pharmaceutical companies and healthcare providers to plan and achieve desired products for effective treatment and meet patients’ needs. In view of this, the review paper highlights the general concepts of QbD and discusses some approaches that are employed to formulate fixed-dose combination/bilayer tablets. The current review also highlights some challenges that might impede the patronage of QbD approach. It is established that the utilization of QbD methodology has proven to have impacted positively and helped in the optimization of the quality of fixed- dose combination/bilayer tablets. QbD is a regulatory requirement for product development in all regulated markets, and its implementation leads to an improvement in product safety, quality, and patient compliance. Despite the challenges associated with its implementation, the benefits are numerous, and it is an essential tool for producing high-quality pharmaceutical products.

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The authors declare no conflict of interest.

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The datasets used in this study are openly available at [repository link] and the source code is available on GitHub at [GitHub link].

This work did not receive any external funding.