Near Infrared and Frequency Modulated Spectroscopy as Non-Invasive Methods for Moisture Assessment of Freeze-Dried Biologics.

Journal of Pharmaceutical Sciences
Richard P AffleckTimothy R McCoy

Abstract

Near-infrared (NIR) and frequency modulated spectroscopy (FMS) were employed, for non-invasive moisture determination of a lyophilized biologic drug product (DP). Development of NIR and FMS provides a rapid non-invasive means of residual moisture measurement, and would be beneficial compared with traditional time consuming, product destructive methods such as Karl Fischer (KF). A model therapeutic enzyme in a sucrose-based formulation was employed for proof of concept studies, and NIR and FMS methods were compared side by side for residual moisture analysis. Moisture models were created using lyophilized vials and comparisons were made between the methods using different moisture preparation approaches:1) direct water droplet addition to the vial headspace, 2) use of elevated temperature (80°C), and 3) using various levels of moisture in stoppers generated during the washing and drying procedures, then lyophilizing using the stoppers and placing the sealed vials on stability. The results for direct water addition gave an average percent error for residual moisture of 5.7% for NIR and 9.4% for FMS when compared to KF. The elevated temperature method resulted in an average percent error for residual moisture of 54% for NIR and 43...Continue Reading

References

Nov 1, 1993·Journal of Pharmaceutical and Biomedical Analysis·J A JonesK A Prebble
Jul 30, 2005·Journal of Pharmaceutical Sciences·Shujun BaiMark Cornell Manning
Feb 25, 2006·Journal of Pharmaceutical Sciences·Ken-Ichi IzutsuNobuo Aoyagi
May 29, 2008·Journal of Pharmaceutical Sciences·T KramerL A Gatlin
Feb 2, 2012·PDA Journal of Pharmaceutical Science and Technology·Isobel A Cook, Kevin R Ward
Mar 26, 2014·Journal of Pharmaceutical Sciences·Hjalte TrnkaJukka Rantanen
Apr 5, 2014·Journal of Pharmaceutical and Biomedical Analysis·Ari KauppinenJarkko Ketolainen

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Citations

Sep 22, 2021·International Journal of Pharmaceutics·Ashutosh SharmaHelen Hughes

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