Stability of freeze-dried products subjected to microcomputed tomography radiation doses. (11th February 2021)

• Record Type: Journal Article
• Authors: Wenzel, Tim; Sack, Achim; Müller, Patrick; Poeschel, Thorsten; Schuldt-Lieb, Sonja; Gieseler, Henning
• Is Part Of: Journal of pharmacy and pharmacology. Volume 73:Number 2(2021)
• Page Start: 212
• Page End: 220
• Publication Date: 2021-02-11
• Subjects: freeze-drying -- micro computed tomography -- morphology -- inspection -- stability; Pharmacy -- Periodicals; Pharmacology -- Periodicals; 615.1
• DOI: 10.1093/jpp/rgaa004
• Languages: English
• ISSNs: 0022-3573

Abstract

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.