Abstract:

Diabetes mellitus is a growing global health burden, and its effective management often requires sustained therapeutic action through controlled drug release systems. This research explores an eco-friendly approach to developing controlled release formulations of anti-diabetic drugs using a Quality-by-Design (QbD) framework. The study focuses on integrating green pharmaceutical manufacturing principles with QbD tools such as risk assessment, design of experiments (DoE), and process analytical technology (PAT). Sustainable polymers, solvent-free or aqueous-based processes, and minimal waste strategies are emphasized. A case study on the development of a metformin hydrochloride matrix tablet is presented to demonstrate the proposed framework. The outcome suggests that incorporating eco-design principles into QbD can ensure product efficacy, regulatory compliance, and environmental responsibility.

Description:

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