An exploratory study of a simplified approach to evaluate drug solubility in milk related vehicles

Sean Li, Justin Gabriel, Marilyn Martinez, David Longstaff, Martin Coffey, Fang Zhao
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引用次数: 0

Abstract

Abstract Objectives Milk related materials are frequently used as a vehicle for drug product administration. Therefore, drug solubility information in milk related vehicles is desirable for prediction of how they may influence in vivo drug release and bioavailability. However, there are very limited data published on this topic. This study explored a practical method to address the key challenges associated with solubility assessment in milk, including the sample equilibration time and cleanup procedures. Methods Amitriptyline, acetaminophen, dexamethasone, nifedipine, piroxicam, and prednisolone were selected as model drugs to represent a wide range of physicochemical properties. Their solubilities were determined at room temperature in pH 6.8 phosphate buffer, skim milk, whole milk, reconstituted milk powder, and unprocessed raw milk. Results The overall results confirmed that milk greatly improves the solubility of poorly water-soluble drugs. However, the extent of improvement and mechanism of solubilization appeared unique for each drug, highlighting the importance of evaluating milk solubility experimentally. Conclusions The method used in this exploratory study can be applied in future investigations of a broader range of drugs and milk-related vehicles.
一种评估药物在牛奶相关载体中溶解度的简化方法的探索性研究
摘要目的乳相关物质经常被用作药物给药的载体。因此,药物在牛奶相关载体中的溶解度信息对于预测它们如何影响体内药物释放和生物利用度是必要的。然而,关于这一主题发表的数据非常有限。本研究探索了一种实用的方法来解决与牛奶中溶解度评估相关的关键挑战,包括样品平衡时间和清理程序。方法选择阿米替林、对乙酰氨基酚、地塞米松、硝苯地平、吡罗昔康、强的松龙等具有广泛理化性质的模型药物。在室温下测定了它们在pH为6.8的磷酸盐缓冲液、脱脂牛奶、全脂牛奶、重组奶粉和未加工原料奶中的溶解度。结果总体结果证实,乳汁能显著提高难水溶性药物的溶解度。然而,每种药物的改善程度和增溶机制似乎都是独特的,这突出了实验评估牛奶溶解度的重要性。结论本探索性研究方法可应用于今后更广泛的药物及乳相关载体的研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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