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注射用药物剂型开发的溶解度原理与实践

Solubility principles and practices for parenteral drug dosage form development.

作者信息

Sweetana S, Akers M J

机构信息

Pharmaceutical Sciences, Lilly Research Laboratories, Indianapolis, Indiana, USA.

出版信息

PDA J Pharm Sci Technol. 1996 Sep-Oct;50(5):330-42.

PMID:8973121
Abstract

Solubilization of poorly water soluble or water insoluble drugs for use in intravenously administered dosage forms is a very formidable task for the parenteral formulation scientist. We have briefly reviewed pertinent literature for parenteral drug solubilization and provided tabular information to assist parenteral formulation scientists in tackling and solving their solubility problems. However, until we can better understand and predict solubility behavior in interactive solvent systems, the why's and how's for parenteral drug solubilization using acceptable (safe and regulatory compliant) approaches will largely remain an empirical effort, leaving great opportunities for scientists to get more involved in this field.

摘要

对于肠胃外制剂科学家而言,将难溶于水或不溶于水的药物增溶以用于静脉给药剂型是一项极具挑战性的任务。我们简要回顾了肠胃外药物增溶的相关文献,并提供了表格信息,以帮助肠胃外制剂科学家应对和解决其溶解性问题。然而,在我们能够更好地理解和预测交互式溶剂系统中的溶解行为之前,使用可接受的(安全且符合法规要求)方法进行肠胃外药物增溶的原理和方式在很大程度上仍将是一种经验性的工作,这为科学家更多地参与该领域留下了巨大的机会。

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