Integrating Moisture Sorption, Hygroscopic Kinetics, and Mechanical Analysis to Forecast Leakage and Shelf Life of Gelatin Soft Capsules.

The objective of this study was to develop a predictive methodology for assessing the leakage phenomenon of gelatin-based soft capsules under various storage conditions. The equilibrium moisture content of the soft capsules was influenced by the temperature and humidity. The leakage phenomenon was attributable to the swelling of gelatin, as revealed by Fourier Transform Infrared spectroscopy (FT-IR) and Scanning Electron Microscopy (SEM) imaging techniques. Additionally, the moisture diffusion mechanism of soft capsule shells was systematically investigated based on the principles of hygroscopic kinetics, enabling quantitative evaluation of their hygroscopic performance under different environmental conditions. Based on macromechanical analysis, the mechanical failure curves of soft capsule shells under different environmental conditions were investigated, enabling successful determination of the shelf life of the soft capsules. Importantly, the Arrhenius equation and the generalized Eyring model were introduced to successfully predict the occurrence of leakage during storage. The developed prediction method performs successful and accurate stability assessment under various conditions, which is crucial for the development of soft capsules.