Mahesha B S, Sheeba F R, Deepak H K
Department of Pharmaceutics, Mallige College of Pharmacy, Bangalore, Karnataka, India.
Drug Dev Ind Pharm. 2025 Apr 27:1-11. doi: 10.1080/03639045.2025.2496940.
This review explores green approaches to enhance poorly water-soluble drug solubility. Implementing sustainable and green techniques, it provides a comprehensive overview of advancements and applications in drug development.
Drug solubility is a key challenge in pharmaceutical research, affecting bioavailability and efficacy. Conventional methods often rely on hazardous solvents and energy-intensive processes, posing environmental and safety concerns. This review emphasizes green chemistry principles as sustainable alternatives to enhance solubility while supporting global sustainability goals.
Natural and biodegradable polymers in solid dispersions offer effective, eco-friendly solubility enhancement. The application of supercritical CO demonstrates significant potential as a green solvent for solubility enhancement, offering scalability while minimizing environmental impact. Plant-derived and renewable excipients offer a sustainable alternative to synthetic additives.
Natural polymers face formulation, solubility, and batch variability issues. Deep eutectic solvents and ionic liquids face stability, regulatory hurdles, toxicity risks, and hygroscopicity. Supercritical fluid technology requires costly equipment and precise optimization. Green co-crystallization faces co-former selection, scalability, and stability issues. Further refinement, safety validation, and industrial feasibility studies are needed.
Green solubility enhancement methods face scalability, regulatory, and cost challenges. Some offer limited solubility gains and stability issues. Ensuring cost-effectiveness, industrial viability, and compliance is key for broader adoption.
Green solubility enhancement offers a sustainable solution to drug solubility challenges. Integrating these methods improves efficiency, safety, and environmental impact. This review highlights the need for further research and the adoption of sustainable drug delivery approaches.
本综述探讨提高难溶性药物溶解度的绿色方法。通过实施可持续和绿色技术,全面概述药物开发中的进展和应用。
药物溶解度是药物研究中的关键挑战,影响生物利用度和疗效。传统方法通常依赖有害溶剂和能源密集型工艺,带来环境和安全问题。本综述强调绿色化学原则作为可持续替代方法,以提高溶解度,同时支持全球可持续发展目标。
固体分散体中的天然和可生物降解聚合物可有效、环保地提高溶解度。超临界CO的应用作为提高溶解度的绿色溶剂具有巨大潜力,具有可扩展性,同时将环境影响降至最低。植物源和可再生辅料为合成添加剂提供了可持续的替代品。
天然聚合物面临制剂、溶解度和批次变异性问题。低共熔溶剂和离子液体面临稳定性、监管障碍、毒性风险和吸湿性问题。超临界流体技术需要昂贵的设备和精确的优化。绿色共结晶面临共形成物选择、可扩展性和稳定性问题。需要进一步完善、安全验证和工业可行性研究。
绿色溶解度提高方法面临可扩展性、监管和成本挑战。一些方法溶解度提高有限且存在稳定性问题。确保成本效益、工业可行性和合规性是更广泛采用的关键。
绿色溶解度提高为药物溶解度挑战提供了可持续解决方案。整合这些方法可提高效率、安全性和环境影响。本综述强调了进一步研究和采用可持续药物递送方法的必要性。