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image of Next-Generation Green Excipients in Drug Delivery: Regulatory Pathways, Safety Considerations, and Innovation

Abstract

The pharmaceutical business is transitioning to a more sustainable model, with a greater emphasis on next-generation and green excipients to improve medicine formulation while reducing environmental impact. However, incorporating these innovative excipients into pharmaceutical development presents regulatory uncertainty, safety concerns, and compliance issues. This analysis delves into the growing regulatory framework governing next-generation excipients, emphasizing the difficulties of toxicological examination, approval routes, and worldwide regulatory agency harmonization initiatives. The article discusses the scientific advances that are driving the development of green excipients, including biodegradable polymers, plant-derived stabilizers, and biocompatible nanocarriers, as well as their safety profiles, biopharmaceutical performance, and scalability. It also examines regulatory challenges such as the lack of standardized evaluation frameworks, the necessity for and in silico risk assessment models, and the importance of Good Manufacturing Practices (GMP) and regulatory filings in assuring compliance. Furthermore, this study assesses the balance between innovation and regulation, arguing that the desire for environmentally friendly pharmaceutical excipients must be balanced with severe safety and effectiveness criteria. The possibility for regulatory change, collaborative industry efforts, and AI-driven predictive toxicity is also investigated as a significant facilitator for speeding up next-generation excipient approval. As the pharmaceutical industry adopts green chemistry concepts, bridging the gap between innovation and regulatory compliance will be critical for long-term medication development. This paper discusses how to overcome present hurdles and establish a proactive regulatory environment that promotes the safe and efficient use of next-generation excipients.

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2025-10-10
2026-02-01

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/content/journals/ddl/10.2174/0122103031397135251005101740
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Next-Generation Green Excipients in Drug Delivery: Regulatory Pathways, Safety Considerations, and Innovation
Bentham Science Publishers ; https://doi.org/10.2174/0122103031397135251005101740
/content/journals/ddl/10.2174/0122103031397135251005101740
/content/journals/ddl/10.2174/0122103031397135251005101740
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  • Article Type:     Review Article
Keywords: green chemistry ; green excipient ; pharmacovigilance ; nanoparticle ; Novel excipient ; regulatory compliance

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