新型基于牛奶的口服制剂的稳定性和理化特性表征。
Stability and physicochemical characterization of novel milk-based oral formulations.
机构信息
Laboratory of Biopharmaceutics-Pharmacokinetics, Faculty of Pharmacy, University of Athens, Panepistimiopolis, GR-15771, Athens, Greece.
出版信息
Int J Pharm. 2013 Feb 28;444(1-2):128-38. doi: 10.1016/j.ijpharm.2013.01.022. Epub 2013 Jan 20.
PURPOSE
The purpose of this work was to assess the colloidal stability of novel milk-based formulations.
METHODS
Milk-based formulations were prepared in situ by adding into milk alkaline- or ethanolic-drug solutions containing an array of drugs namely; ketoprofen, tolfenamic acid, meloxicam, tenoxicam and nimesulide, mefenamic acid, cyclosporine A, danazol and clopidogrel besylate. The produced formulations were characterized by means of dynamic lightscattering, ζ-potential studies, atomic force microscopy, fluorescence spectroscopy, Raman spectroscopy complemented with ab initio calculations and stability studies.
RESULTS
The presence of the drugs did not induce significant changes in most cases to the particle size and ζ-potential values of the emulsions pointing to the colloidal stability of these formulations. Raman spectroscopy studies revealed interactions of the drugs and the milk at the intermolecular level. Complementary analysis with ab initio calculations confirmed the experimental observations obtained by Raman spectroscopy. Finally the produced drug containing alkaline/ethanolic solutions exhibited stability over a period of up to 12 months.
CONCLUSIONS
The current data demonstrate that milk is a promising drug carrier.
目的
本工作旨在评估新型乳剂制剂的胶体稳定性。
方法
通过向含有一系列药物（如酮洛芬、托芬那酸、美洛昔康、替诺昔康和尼美舒利、甲芬那酸、环孢素 A、丹那唑和氯吡格雷）的碱性或乙醇药物溶液中加入乳剂原位制备乳剂制剂。采用动态光散射、ζ-电位研究、原子力显微镜、荧光光谱、拉曼光谱辅以从头算计算和稳定性研究对所制备的制剂进行了表征。
结果
在大多数情况下，药物的存在并没有对乳液的粒径和 ζ-电位值产生显著影响，这表明这些制剂具有胶体稳定性。拉曼光谱研究表明药物和牛奶在分子间水平上发生了相互作用。与从头算计算的补充分析证实了拉曼光谱获得的实验观察结果。最后，所制备的含碱性/乙醇溶液的药物在长达 12 个月的时间内表现出稳定性。
结论
目前的数据表明，牛奶是一种有前途的药物载体。
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