학술논문

Use of Time-Domain NMR for 1 H T 1 Relaxation Measurement and Fitting Analysis in Homogeneity Evaluation of Amorphous Solid Dispersion.
Document Type
Academic Journal
Author
Okada K; Laboratory of Pharmaceutical Technology, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan. Electronic address: kokada@pha.u-toyama.ac.jp.; Ono T; Laboratory of Pharmaceutical Technology, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan; Formulation Development Department, Development & Planning Division, Nichi-Iko Pharmaceutical Co., Ltd., 205-1 Shimoumezawa, Namerikawa-shi, Toyama 936-0857, Japan.; Hayashi Y; Formulation Development Department, Development & Planning Division, Nichi-Iko Pharmaceutical Co., Ltd., 205-1 Shimoumezawa, Namerikawa-shi, Toyama 936-0857, Japan.; Kumada S; Formulation Development Department, Development & Planning Division, Nichi-Iko Pharmaceutical Co., Ltd., 205-1 Shimoumezawa, Namerikawa-shi, Toyama 936-0857, Japan.; Onuki Y; Laboratory of Pharmaceutical Technology, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama 930-0194, Japan.
Source
Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE
Subject
Language
English
Abstract
This study examined the usefulness of 1 H T 1 relaxation measurements for evaluating the homogeneity of amorphous solid dispersion (ASD). Indomethacin and polyvinylpyrrolidone were used to prepare two kinds of ASDs. One was inhomogeneous ASD (ASD melt ) prepared by a melt-quenching method, and the other was homogeneous ASD (ASD solvent ) prepared by a solvent evaporation method. The T 1 relaxation was measured by the time-domain NMR (TD-NMR) technique using a low-field NMR system. Curve-fitting analysis of T 1 relaxation plots was conducted using the Akaike information criterion. This fitting analysis revealed that the T 1 relaxation of ASD melt and ASD solvent was biphasic and monophasic, respectively. ASD melt and ASD solvent were inhomogeneous and homogeneous on a nanometer scale, respectively, considering the spin diffusion of 1 H nuclei. These T 1 results were consistent with the Raman mapping of ASDs. From the fitting analysis of 1 H T 1 relaxation, we conclude that TD-NMR is a promising technique for evaluating ASD homogeneity.
Competing Interests: Declaration of Competing Interest The authors declare that they have no financial or competing interests concerning this manuscript. The Laboratory of Pharmaceutical Technology, University of Toyama, is an endowed department supported by an unrestricted grant from Nichi-Iko Pharmaceutical Co. (Toyama, Japan).
(Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)