Application of ¹⁹ F time‐domain NMR to measure content in fluorine‐containing drug products

Abstract

It is necessary to show that the active content in the dosage form of drugs is within a certain narrow range of the label claim. In case of fluorinated drugs, the active content can be measured by high field solid state NMR because the excipients lack fluorine. To make NMR reachable to any laboratory, simple to use, and at a low cost, measurement of (19) F nucleus using a 23 MHz (for (1) H) low field benchtop time-domain (TD) NMR was investigated. Three fluorinated drug products, cinacalcet, lansoprazole, and ciprofloxacin, were chosen for this study. The doses for these drug products range from 15 to 500 mg. The average drug content measured using (19) F TD-NMR compares well with the reported label claims for the three drugs tested. (19) F TD-NMR is a simple and non-destructive technique to measure drug content in tablets. In addition, the accessibility and simplicity of the technique makes it an excellent process analytical technology tool for development and manufacturing in the pharmaceutical industry. Copyright © 2015 John Wiley & Sons, Ltd.

Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access

“…Recent publications have highlighted the use of benchtop NMR analysis as a nondestructive tool to analyze both solid and liquid drug products. Benchtop NMR, which has a small footprint and is nondestructive, has been used to analyze contents of tablets, [78] aggregation in monoclonal antibody liquid product [79,80], and adjuvant fill levels for vaccines [81]. These systems have the potential to aid in biophysical characterization, lot release testing, and stability assessment of the drug product at the fill finish facility.…”