Abstract

QUALITY BY DESIGN APPROACHES (QbD) IN THE DEVELOPMENT OF HYDROGEL-BASED DRUG DELIVERY SYSTEMS

Yash S. Gaikwad*, Roshni D. Patil*, Shailesh S. Chalikwar

ABSTRACT

In drug delivery systems based on hydrogel, the Quality by Design (QbD) strategy promotes proactive planning through the systematic design, optimization, and control of formulation factors to ensure product quality and performance. To enhance the development of high-quality pharmaceutical products, the FDA embraced the Quality by Design (QbD) approach in the pharmaceutical sector, to achieve a comprehensive understanding of how material attributes and process parameters influence the quality and performance of the final products. Scientists are intrigued by hydrogel drug delivery systems due to a variety of reasons, such as high-water content, biocompatibility with biological products, structural variability, and the potential for administration via multiple routes. Incorporating QbD principles into hydrogel formulation ensures that the drug's physicochemical characteristics and release pattern are modulated to attain desired therapeutic targets. Such a strategy focuses on the determination of critical quality attributes (CQAs), critical process parameters (CPPs), and design space that is robust, thereby enabling the prediction of the result and the reduction of variability during manufacturing. Through tools like Design of Experiments (DOE), risk assessment, and sophisticated characterization methods, QbD facilitates the development of hydrogels that have ideal drug release rates, improved stability, and site-specific delivery. In this summary, we describe the place of the QbD approach in hydrogel-based drug delivery systems research and development, emphasizing key applications and means of applying the approach. We further address the challenges associated with it, such as the requirement for thorough characterization, regulatory approval, and scale-up from laboratory to industrial. Ultimately, QbD offers a structured framework for designing and manufacturing hydrogel-based drug delivery systems, ensuring product consistency and therapeutic efficacy.

Keywords: QbD; Hydrogel; Drug Delivery; Quality Target Product Profile; Critical Quality Attributes; Critical Material Attributes; Critical Process Parameter; Design of Experiment.