Nondestructive Quantitative Inspection of Drug Products Using Benchtop NMR Relaxometry-the Case of NovoMix® 30.

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TitleNondestructive Quantitative Inspection of Drug Products Using Benchtop NMR Relaxometry-the Case of NovoMix® 30.
Publication TypeJournal Article
Year of Publication2019
AuthorsBriggs, KT, Taraban, MB, Wang, W, Y Yu, B
JournalAAPS PharmSciTech
Volume20
Issue5
Pagination189
Date Published2019 May 20
ISSN1530-9932
KeywordsBiphasic Insulins, Insulin Aspart, Insulin, Isophane, Magnetic Resonance Spectroscopy, Protons, Quality Control, Water
Abstract

Batch-level inference-based quality control is the standard practice for drug products. However, rare drug product defects may be missed by batch-level statistical sampling, where a subset of vials in a batch is tested quantitatively but destructively. In 2013, a suspension insulin product, NovoLog® Mix 70/30 was recalled due to a manufacturing error, which resulted in insulin strength deviations up to 50% from the labeled value. This study analyzed currently marketed FlexPen® devices by the water proton transverse relaxation rate using a benchtop nuclear magnetic resonance relaxometer. The water proton transverse relaxation rate was found to be sensitive to detecting concentration changes of the FlexPen® product. These findings support the development of vial-level verification-based quality control for drug products where every vial in a batch is inspected quantitatively but nondestructively.

DOI10.1208/s12249-019-1405-0
Alternate JournalAAPS PharmSciTech
PubMed ID31111256