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Kinetic Model of Diclofenac Degradation Developed Using Multivariate Curve Resolution Method
Authors:Oxana Ye. Rodionova  Alexey L. Pomerantsev  Douglas N. Rutledge
Affiliation:1.Semenov Federal Research Center for Chemical Physics RAS, Kosygin 4, 119991 Moscow, Russia;2.Faculté de Pharmacie, Université Paris-Saclay, 17 Avenue des Sciences, 91400 Orsay, France;3.Muséum National d’Histoire Naturelle, 63 rue Buffon, 75005 Paris, France
Abstract:This study presents the kinetic modeling of the natural long-term aging of the pharmaceutical substance as well as the intact tablets of Diclofenac. Datasets are collections of near-infrared spectra acquired from the intact tablets packed in plastic blisters and the spectra of the pure substance. Fresh samples and samples at different stages of degradation are analyzed. No methods of accelerated aging were applied. Multi-step application of MCR-ALS in its soft version followed by the kinetic modeling of the results helps to propose a generic degradation mechanism; which includes: a global kinetic model; approximations of the NIR spectra of the intermediate and product; rough estimates of rate constants. We study tablets in blister packs; exactly as they are presented in pharmacies; and this is important from a practical point of view.
Keywords:MCR-ALS   kinetic modeling   long-term natural aging   Diclofenac substance and intact tablets   NIR spectroscopy
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