关于制药辅助剂的综合性审查
Rachana D Pockle1, Rajashree S Masareddy1, Archana S Patil1
1Department of Pharmaceutics, KLE College of Pharmacy, KLE Academy of Higher Education & Research, Nehru Nagar, Belagavi, 590010, Karnataka, India.
Therapeutic delivery
|July 19, 2023
概括
药物辅助剂对于药物的有效性至关重要,从不活性成分演变为必不可少的配方成分. 本次审查涵盖了它们的分类和安全评估指南.
科学领域:
- 制药科学 制药科学
- 药物运输 药物运输 药物运输
- 制定 发展 制定 发展
背景情况:
- 制药辅助剂,曾经被认为是无效的,现在被认为是药物配方的重要组成部分,占最终产品的80-90%.
- 药物输送系统和生物制药的进步使人们越来越关注辅助剂的作用和功能,特别是在固体剂型中.
研究的目的:
- 根据国际制药辅助剂理事会 (IPEC) 的指导方针,审查制药辅助剂的分类.
- 概述用于评估新药辅助剂安全性的既定指导方针.
主要方法:
- 关于制药辅助剂作用和分类的文献综述.
- 国际制药辅助剂理事会 (IPEC) 标准和安全评估框架的分析.
主要成果:
- 助剂对于药物的有效性和输送至关重要,而不仅仅是惰性填充剂.
- IPEC提供了一个标准化框架,用于分类辅助剂.
- 已有指导方针用于评估进入市场的新辅助剂的安全性.
结论:
- 制药辅助剂的作用已经显著演变,影响了药物的有效性和输送.
- 标准化分类和安全性评估对于药物配方中辅助剂的负责任开发和使用至关重要.
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