Articles by Alan M. Kook in JoVE
Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products Maria Victoria Silva Elipe1, Lan Li1, Karthik Nagapudi2, Alan M. Kook3, Carlos Cobas4, Isaac Iglesias4, Chen Peng4 1Department of Attribute Sciences, Amgen, Inc., 2Small Molecule Pharmaceutical Sciences, Genentech, Inc., 3NMR Service + Consulting, 4Mestrelab Research A simple and non-destructive technique that measures the average content of drug substances in formulated drug products containing fluorine using low-field fluorine-19 (19F) time-domain (TD) nuclear magnetic resonance (NMR) is presented here. The technique can be applied to the development and manufacturing of drugs in the pharmaceutical industry.
Other articles by Alan M. Kook on PubMed
Application of (19) F Time-domain NMR to Measure Content in Fluorine-containing Drug Products Magnetic Resonance in Chemistry : MRC. Jun, 2016 | Pubmed ID: 25773191 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.