Pharmaceutical Applications of Relaxation Filter-Selective Signal Excitation Methods for ¹⁹F Solid-State Nuclear Magnetic Resonance: Case Study With Atorvastatin in Dosage Formulation

Journal of Pharmaceutical Sciences
Mamiko AsadaHisashi Mimura

Abstract

We recently developed several new relaxation filter-selective signal excitation (RFS) methods for (13)C solid-state nuclear magnetic resonance (NMR) that allow (13)C signal extraction of the target components from pharmaceuticals. These methods were successful in not only qualification but also quantitation over the wide range of 5% to 100%. Here, we aimed to improve the sensitivity of these methods and initially applied them to (19)F solid-state NMR, on the basis that the fluorine atom is one of the most sensitive NMR-active nuclei. For testing, we selected atorvastatin calcium (ATC), an antilipid BCS class II drug that inhibits 3-hydroxy-3-methylglutaryl-coenzyme A reductase and is marketed in crystalline and amorphous forms. Tablets were obtained from 2 generic drug suppliers, and the ATC content occurred mainly as an amorphous form. Using the RFS method with (19)F solid-state NMR, we succeeded in qualifying trace amounts (less than 0.5% w/w level) of crystalline phase (Form I) of ATC in the tablets. RFS methods with (19)F solid-state NMR are practical and time efficient and can contribute not only to the study of pharmaceutical drugs, including those with small amounts of a highly potent active ingredient within a formulate...Continue Reading

References

Jan 5, 2000·Journal of Magnetic Resonance·B M FungK Ermolaev
Nov 7, 2003·Journal of Pharmaceutical Sciences·David C ApperleyTorsten Malmstrom
Feb 14, 2004·Advanced Drug Delivery Reviews·Dharmendra Singhal, William Curatolo
Nov 1, 2005·Journal of Pharmaceutical Sciences·Thomas J OfferdahlEric J Munson
Jul 6, 2006·Solid State Nuclear Magnetic Resonance·Philip WormaldPaul Hazendonk
Mar 1, 2012·The Journal of Physical Chemistry. B·Wei David WangCecil Dybowski
Mar 17, 2012·Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy·Martina UrbanovaLibor Kobera

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Citations

Sep 19, 2018·Angewandte Chemie·Mingzhang WangTatyana Polenova
Apr 8, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Chaima TizaouiIvo B Rietveld

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