In-Situ Molecular Vapor Composition Measurements During Lyophilization

Abstract

Chamber process gas composition during lyophilization is quantified for several representative formulations using residual gas analysis. The advantages of the technique lie in its ability to measure the relative concentration of various species during the lyophilization process. This feature gives residual gas analysis utility in a host of applications from endpoint determination to quality assurance. In contrast to other methods, residual gas analysis is able to determine oxygen and water vapor content in the process gas. These compounds have been shown to directly influence product shelf life. With these results, residual gas analysis technique presents a potential new method for real-time lyophilization process control and improved understanding of formulation and processing effects for lyophilized pharmaceutical products.

Formulation and Manufacturing of Solid Dosage Forms

“…Traditional solid-state Fourier Transform Infrared Spectroscopy (ss-FTIR), solid-state fluorescence spectroscopy and relatively new method of solid-state hydrogen deuterium exchange with mass spectrometric analysis (ssHDX-MS) were employed in this study. Additionally, Liechty et al investigated temporal evolution of the process gas during lyophilization using residual gas analysis technique (15). The residual gas analysis is able to detect oxygen and water vapor content in the process gas, which directly influence product shelf life.…”