Quality Control and Regulatory Standards for Controlled-Release Tablets: A Global Perspective
DOI:
https://doi.org/10.71222/8qz56v36Keywords:
controlled-release tablets, quality control, dissolution testing, regulatory standards, in vitro–in vivo correlation (IVIVC)Abstract
Controlled-release (CR) tablets play a crucial role in modern pharmaceutical formulations by enhancing therapeutic efficacy, reducing dosing frequency, and improving patient compliance. However, ensuring the quality and regulatory approval of these formulations remains a complex challenge due to variations in manufacturing processes, quality control parameters, and global regulatory requirements. This review provides a comprehensive analysis of CR tablet development, focusing on key formulation principles, quality control methodologies, and regional regulatory frameworks. It explores critical aspects such as dissolution testing, in vitro–in vivo correlation (IVIVC), and stability studies, highlighting the evolving role of artificial intelligence (AI) and emerging formulation technologies in optimizing drug release profiles. Furthermore, the review compares regulatory expectations across major regions, including the United States, European Union, China, and Japan, emphasizing the need for harmonized global standards. Addressing these challenges requires interdisciplinary collaboration to align regulatory requirements, enhance quality control precision, and foster innovation in controlled-release drug delivery.
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