Stability of freeze-dried products subjected to microcomputed tomography radiation doses

Wenzel T, Sack A, Müller P, Pöschel T, Schuldt-Lieb S, Gieseler H (2021)

Publication Type: Journal article

Publication year: 2021

Journal

Journal of Pharmacy and Pharmacology Royal Pharmaceutical Society of Great Britain

Book Volume: 73

Pages Range: 212-220

Journal Issue: 2

DOI: 10.1093/jpp/rgaa004

Abstract

OBJECTIVES: Microcomputed tomography (µCT) is a powerful analytical tool for non-invasive structural analysis. The stability of drug substances and formulations subjected to X-ray radiation may be a concern in the industry. This study examines the effect of X-ray radiation on the stability of freeze-dried pharmaceuticals. The investigation is a proof of concept study for the safety of µCT X-ray radiation doses during the non-destructive investigation of freeze-dried products. METHODS: Different formulations of clotrimazole, insulin and l-lactate dehydrogenase were freeze-dried and the products exposed to a defined dose of radiation by µCT. Conservative freeze-drying conditions were used. Irradiated and normal samples were analysed for their stability directly after freeze-drying and after stability testing. KEY FINDINGS: The stability of model compounds was well maintained during freeze-drying. Some degradation of all compounds occurred during accelerated stability testing. The results showed no differences between the irradiated and normal state directly after freeze-drying and accelerated stability testing. CONCLUSIONS: No evidence of a detrimental effect of 100 Gy X-ray exposure on a model small molecule, peptide and protein compound was found while useful structural information could be obtained. Consequently, the technology may be useful as a non-destructive tool for product inspections if the formulation proves stable.

Authors with CRIS profile

Achim Sack Lehrstuhl für Multiscale Simulation of Particulate Systems Thorsten Pöschel Lehrstuhl für Multiscale Simulation of Particulate Systems

Involved external institutions

Medac GmbH DE Germany (DE) Fraunhofer-Institut für Biomedizinische Technik (IBMT) / Fraunhofer Institute for Biomedical Engineering DE Germany (DE)

How to cite

APA:

Wenzel, T., Sack, A., Müller, P., Pöschel, T., Schuldt-Lieb, S., & Gieseler, H. (2021). Stability of freeze-dried products subjected to microcomputed tomography radiation doses. Journal of Pharmacy and Pharmacology, 73(2), 212-220. https://doi.org/10.1093/jpp/rgaa004

MLA:

Wenzel, Tim, et al. "Stability of freeze-dried products subjected to microcomputed tomography radiation doses." Journal of Pharmacy and Pharmacology 73.2 (2021): 212-220.

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