Affiliations 

  • 1 Laboratory of Pharmaceutical Technology, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama, 930-0194, Japan
  • 2 Formulation Development Department, Development & Planning Division, Nichi-Iko Pharmaceutical Co., Ltd., 205-1, Shimoumezawa Namerikawa-shi, Toyama, 936-0857, Japan
  • 3 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Malaya, 50603 Kuala Lumpur, Malaysia
  • 4 Laboratory of Pharmaceutical Technology, School of Pharmacy and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama, 930-0194, Japan. Electronic address: onuki@pha.u-toyama.ac.jp
Int J Pharm, 2021 Jun 07.
PMID: 34111545 DOI: 10.1016/j.ijpharm.2021.120770

Abstract

The application of time-domain NMR (TD-NMR) analysis to quantify water content in pharmaceutical ingredients is demonstrated. The initial phase of the study employed a range of disintegrants with defined amounts of added water (0-30% of the total weight) as samples; the disintegrants included croscarmellose sodium, corn starch, low-substituted hydroxypropyl cellulose, and crospovidone. After acquisition of the T2 relaxation curves of the samples by TD-NMR measurements, these curves were analyzed by partial least squares (PLS) regression. According to the analysis, accurate and reliable PLS models were created that enabled accurate assessment of water content in the samples. A powder blend consisting of acetaminophen (paracetamol) and tablet excipients was also examined. Both a physical mixture of the powder blend and a wet granule prepared with a high-speed granulator were tested as samples in this study. Precise determination of water content in the powder blend was achieved by using the TD-NMR method. The accuracy of water content determination was equivalent to or better than that of the conventional loss on drying method. TD-NMR analysis samples were measured nondestructively and rapidly with low cost; thus, it could be a powerful quantitative method for determining water content in pharmaceuticals.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.