张鑫, 郝贵周, 王兴华, 尚萍萍. 长效原位成型制剂的产业化突破: 关键技术平台与转化战略J. 药学学报, 2025, 60(10): 3008-3018. DOI: 10.16438/j.0513-4870.2025-0200
引用本文: 张鑫, 郝贵周, 王兴华, 尚萍萍. 长效原位成型制剂的产业化突破: 关键技术平台与转化战略J. 药学学报, 2025, 60(10): 3008-3018. DOI: 10.16438/j.0513-4870.2025-0200
ZHANG Xin, HAO Gui-zhou, WANG Xing-hua, SHANG Ping-ping. Industrialization breakthroughs in long-acting in situ forming drug delivery systems: key technology platforms, and transformation strategiesJ. Acta Pharmaceutica Sinica, 2025, 60(10): 3008-3018. DOI: 10.16438/j.0513-4870.2025-0200
Citation: ZHANG Xin, HAO Gui-zhou, WANG Xing-hua, SHANG Ping-ping. Industrialization breakthroughs in long-acting in situ forming drug delivery systems: key technology platforms, and transformation strategiesJ. Acta Pharmaceutica Sinica, 2025, 60(10): 3008-3018. DOI: 10.16438/j.0513-4870.2025-0200

长效原位成型制剂的产业化突破: 关键技术平台与转化战略

Industrialization breakthroughs in long-acting in situ forming drug delivery systems: key technology platforms, and transformation strategies

  • 摘要: 随着现代医药技术的快速发展, 长效原位成型制剂已成为药物递送领域的重要研究方向。该制剂凭借其独特的药物释放特性: 延长药效时间、提高给药精准度等优势, 为临床治疗提供了创新解决方案。本文通过系统梳理美国食品药品监督管理局、欧洲药品管理局等监管机构已批准产品及国内外在研管线, 深入分析了不同技术平台的特点、产业化进程中的关键技术瓶颈及未来发展趋势, 以期为我国长效制剂的产业化发展提供战略参考。

     

    Abstract: With the rapid development of contemporary medical technology, long-acting in situ forming preparations have emerged as a pivotal area of investigation in the field of drug delivery. Owing to its unique drug release characteristics, sustained therapeutic effect, enhanced dosing precision and other notable benefits, it represents a transformative approach for clinical treatment. In this study, an in-depth analysis of the characteristics of different technology platforms, the critical technical challenges in the process of industrialization and the emerging trends was conducted through a comprehensive review of products approved by FDA, EMA and other regulatory authorities and the research pipelines global and domestic. The findings aim to provide a strategic framework to support the industrialization of long-acting preparations in China.

     

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