辅助剂:复杂挑战的新机遇 USP的解决与辅助剂有关的复杂挑战的方法
Catherine Sheehan1, Jenny Liu1, Peng Zhang1
1Science Division - Excipients, United States Pharmacopeia, Rockville, MD 20852, USA.
概括
高质量的助剂对于纳米药物等先进的药物输送系统至关重要. 美国药典 (USP) 正在制定新的标准和方法,以确保辅助剂的质量,并应对变异性挑战.
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:
- 辅助剂占药品的很大一部分,传统上是根据预期用途而不是成分指定.
- 纳米药物和新型输送系统的兴起需要更高的纯度和辅助剂的质量标准,例如用于疫苗输送的脂.
研究的目的:
- 为了解决复杂辅助剂缺乏标准化测试方法的问题.
- 为辅助剂组成和可变性问题提供解决方案.
- 概述不断发展的综合方法和扩大USP产品的辅助剂质量.
主要方法:
- 美国标准制造公司通过"新兴标准"模式吸引利益相关者参与,以灵活和代地制定质量标准.
- 开发新的综合方法,包括独立的章节.
- 通过分析参考材料 (ARM),应用说明和技术指南扩展产品.
主要成果:
- 美国工业大学正在积极与利益相关者合作,为复杂/聚合物辅助剂创建标准化测试方法.
- 正在提供新的解决方案来管理辅助剂的组成和可变性.
- 提供了不断发展的综合策略和增强的支持材料的概述.
结论:
- 美国药典 (USP) 正在加强其对辅助剂质量标准的方法,以满足先进药物输送系统的需求.
- 合作努力和扩大资源旨在提高复杂辅助剂的可靠性和质量.
- 这些倡议通过确保高质量的辅助剂的稳健供应来支持创新药物的开发.
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