Pharmaceutical Development, Aurigene Discovery Technologies Limited, Bollaram Road, Miyapur, Hyderabad, Andhra Pradesh, India.
Pharm Dev Technol. 2013 Mar-Apr;18(2):348-58. doi: 10.3109/10837450.2011.618947. Epub 2011 Oct 10.
The conventional method of hygroscopicity determination proposed by Callahan and co-workers utilizes more sample and time, may not be precise in all the cases, and is a relatively broader classification system. The method of indicating degree of hygroscopicity as per European Pharmacopoeia considers equilibration of sample for 24 hours under single humidity condition and may not necessarily ensure equilibration in all the cases. Additionally, both these methods do not provide information on solid state changes occurring within the sample during the course of experiment. This research work envisages an efficient throughput method for hygroscopicity determination, and validates it with active and inactive pharmaceutical ingredients using sorption analysis. Further, this method has been performed under optimal equilibration conditions, in a throughput manner (consuming less sample and time), with additional information on solid state changes occurring within the experimental conditions. This throughput method would be a valuable tool for hygroscopicity assessment of new chemical entities, during drug development in particular, and across all pharmaceutical materials in general.
卡勒汉（Callahan）等研究人员提出的传统吸湿率测定方法需要更多的样品和时间，并且并非在所有情况下都精确，属于相对宽泛的分类系统。根据欧洲药典（European Pharmacopoeia）指示吸湿率程度的方法考虑了在单一湿度条件下对样品进行 24 小时的平衡，但并不能保证在所有情况下都达到平衡。此外，这两种方法都无法提供实验过程中样品内发生的固态变化的信息。本研究工作旨在开发一种高效的吸湿率测定方法，并使用吸附分析对活性和非活性药物成分进行验证。此外，该方法在优化的平衡条件下以高通量（消耗更少的样品和时间）的方式进行，并且提供了有关实验条件下发生的固态变化的附加信息。这种高通量方法将成为新化学实体（尤其是在药物开发过程中）以及一般药物材料的吸湿率评估的有价值工具。
