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范围审查以确定未来LCA研究的数据需求和环境热点:对制药辅助剂和过程的洞察力
Anja Autzen Virtanen1, Satu Lakio2, Atif Madi3
1Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Finland.
概括
在生命周期评估 (LCA) 数据有限的情况下,范围审查可以评估药品的环境影响. 这种方法确定了常见辅助剂的环境问题,突出了更多制药可持续性研究的需要.
科学领域:
- 制药科学 制药科学
- 环境科学 环境科学
- 绿色化学 绿色化学
背景情况:
- 药物剂量形式的环境评估正在获得引力.
- 生命周期评估 (LCA) 是标准,但具有高的数据要求和障碍.
- 制药LCA输入数据有限,需要使用其他评估方法.
研究的目的:
- 调查使用范围审查作为药品环境影响评估中LCA的替代方案的可行性.
- 为了确定制药制造工艺和辅助剂的环境信息.
- 突出药品制造可持续性的研究差距.
主要方法:
- 进行了系统的文献审查,选了8788篇文章并确定了117项相关研究.
- 搜索的重点是一个特定的小片剂配方 (甲,PVP/HPMCAS,乳糖,MCC,MgSt).
- 为制造工艺和辅助剂提取的环境数据.
主要成果:
- 对于大多数研究的工艺和辅助剂,发现了相关的环境信息.
- 在环境审查和制药制造的交叉点的研究中观察到显著的上升趋势.
- 通常使用的辅助剂,即使是那些通常被认为是安全的 (GRAS),也可能引起环境问题.
- 辅助剂的多种制造途径使直接环境比较变得复杂.
- 发现了针对制药制造业的可持续性研究的显著缺失.
结论:
- 当数据稀缺时,范围审查是一种可行的LCA替代方案,用于制药环境评估.
- 辅助剂的选择需要仔细考虑安全性以外的环境因素.
- 增加研究对于指导可持续制药配方选择和解决环境影响至关重要.
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