Roskar Robert, Kmetec Vojko
Faculty of Pharmacy, University of Ljubljana, Askerceva 7, 1000 Ljubljana, Slovenia.
Chem Pharm Bull (Tokyo). 2005 Jun;53(6):662-5. doi: 10.1248/cpb.53.662.
Moisture content of solid-state pharmaceutical products is one of the main factors that affect drug stability, therefore suitable sorption studies need to be performed to assure drug quality throughout their shelf life. The Brunauer-Emmett-Teller (BET) and the Guggenheim-Anderson-de Boer (GAB) models are usually used for this purpose. Using gravimetrically obtained data, both methods were applied in the present work to evaluate the sorption characteristics of several excipients. Microcalorimetric analysis was also performed in order to evaluate the interaction between water and the substances. The results of these experiments show excellent agreement between data and the BET model up to 55% RH and the GAB model over the entire humidity range, confirmed by high values of the statistical determination coefficients. Furthermore, microcalorimetric measurements suggested that the hygroscopicity of solid materials could be estimated approximately using this approach.
固态药品的水分含量是影响药物稳定性的主要因素之一，因此需要进行适当的吸附研究，以确保药品在整个保质期内的质量。通常使用布鲁诺尔-埃米特-泰勒（BET）模型和古根海姆-安德森-德布尔（GAB）模型来进行此项研究。在本研究中，利用重量法获得的数据，采用这两种方法评估了几种辅料的吸附特性。还进行了微量热分析，以评估水与这些物质之间的相互作用。实验结果表明，在相对湿度高达55%时，数据与BET模型吻合良好，在整个湿度范围内与GAB模型吻合良好，统计决定系数的高值证实了这一点。此外，微量热测量表明，使用这种方法可以大致估算固体材料的吸湿性。
