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[交流] 关于使用动态水分吸附仪定量检测晶体中混杂无定型成分的含量

近来听到不少关于采用吸附等温线进行定量分析混合物中无定型成分含量的讨论，刚好读到一篇不错的论文，是关于定量检测无定型乳糖含量的方法，不知道现在在国内研究领域是何种情况，希望有兴趣的朋友一起讨论。

Int J Pharm. 2010 Aug 16;395(1-2):62-70. doi: 10.1016/j.ijpharm.2010.04.035. Epub 2010 May 21.

Determination of low levels of amorphous content in inhalation grade lactose by moisture sorption isotherms.

Vollenbroek J1, Hebbink GA, Ziffels S, Steckel H.

Author information

Abstract

Alpha-lactose monohydrate is widely used as an excipient in dry powder inhalers, and plays a very important role in the efficiency of the drug delivery. Due to the processing, low levels of amorphous lactose could be present in the blends. Varying amounts could have a strong effect on the efficiency of drug delivery of the powder blends. Therefore, the accurate measurement of low levels of amorphous lactose content is very important. A new method was developed to measure the amorphous content, based on dynamic vapour sorption (DVS). In contrast to the traditional re-crystallization approach of amorphous lactose, the new method is based on moisture sorption isotherms. Moisture sorption isotherms of blends of crystalline alpha-lactose and freeze-dried or spray-dried amorphous lactose were measured. By fitting the data with a Brunauer, Emmett, and Teller (BET) isotherm, a linear correlation was found between measured and actual amorphous content for the whole range of 0.1-100%. Differences between freeze-dried and spray-dried lactose, due to different molecular arrangements, could be removed by a preconditioning the samples at 35% RH prior to the isotherm measurement. It was shown that accurate determination of very low concentrations of amorphous lactose content is possible using moisture sorption isotherm analyses.

Copyright (c) 2010 Elsevier B.V. All rights reserved.

PMID:

20493937

DOI:

10.1016/j.ijpharm.2010.04.035

[Indexed for MEDLINE]

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