(184x) Hybrid Modelling for Semi-Permeable Membranes: A Water Vapor Transmission Rate (WVTR) Stability Estimation.

Stability studies for sterile injectables are an essential step in developing a globally acceptable drug product. The products presented in semi-permeable polymer films tend to lose water when exposed to the standard temperature & relative humidity conditions, following the ICHQ1A guideline. The proposed hybrid model utilizes a constant flux, quasi-steady state approach to estimate the % water loss, using the first-principle permeability model. The existing data from historical cases and extended predictions from the first-principle model were utilized to develop a Machine Learning (ML) based user interface (UI), specific to different types of semi-permeable packaging material currently utilized by the Pfizer community. The UI can be fully leveraged to estimate the water loss % at a longer duration, and substantial long-term WVTR studies can be avoided or estimated well ahead. The model is mathematically validated and compared with the existing experimental data, and the maximum error was found to be < 2.5% for all presentation volumes.