Efficient throughput method for hygroscopicity classification of active and inactive pharmaceutical ingredients by water vapor sorption analysis

Abstract

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.

Keywords::

• Hygroscopicity
• water vapor sorption
• adsorption
• desorption
• pre-formulation

Acknowledgments

Authors wish to thank Dr. Reddy’s Laboratories Ltd. and Aurigene Discovery Technologies Ltd. for their support in this research work. Scientific support provided by TA Instruments Ltd. in interpreting sorption analysis data is also greatly acknowledged.

Declaration of interest

The authors report no declarations of interest.