对工业认可的聚合物和无形固体分散基配方的制造工艺的审查
Sumit Kumar Saha1,2, Amita Joshi3, Romi Singh2
1Department of Pharmacology, School of Pharmaceutical Education & Research, Jamia Hamdard, New Delhi, India.
Pharmaceutical development and technology
|July 10, 2023
概括
无形固体分散 (ASD) 技术增强了难以溶解的药物. 本综述指导了在制药行业成功制备ASD的聚合物和制造选择.
科学领域:
- 制药科学 制药科学
- 药物运输 药物运输 药物运输
- 材料科学 材料科学 材料科学
背景情况:
- 药物发现的进步产生了更难溶的化合物.
- 无形固体分散 (ASD) 是提高药物的溶解性和生物可用性的关键策略.
- 目前在FDA批准的ASD产品中使用有限的聚合物和制造选项.
研究的目的:
- 为ASD配方提供聚合物和制造技术的全面指南.
- 讨论ASD中的聚合物稳定机制.
- 在设计质量 (QbD) 框架内展示ASD制造技术.
主要方法:
- 审查美国FDA批准的无形固体分散产品.
- 分析聚合物及其稳定机制 (溶液和固态).
- 商业化ASD制造技术的检查,包括设计质量 (QbD).
主要成果:
- 在批准的ASD产品中确定了一组有限的常用聚合物和制造技术.
- 详细介绍了聚合物增强溶液状态和固态稳定的机制.
- 以设计质量 (QbD) 格式呈现制造工艺.
结论:
- 有效选择聚合物和制造技术对于成功的ASD配方至关重要.
- 本综述提供了对开发具有挑战性的药物配方的行业公认方法的见解.
- 新兴的辅助剂和先进的制造技术对未来的ASD发展充满希望.
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