Correlation of Phosphorus Cross-Linking to Hydration Rates in Sodium Starch Glycolate Tablet Disintegrants Using MRI

Anuji Abraham, Dolapo Olusanmi, Andrew J. Ilott, David Good, Denette Murphy, Daniel McNamara, Alexej Jerschow, Rao V. Mantri

Research output: Contribution to journalArticle

Abstract

Understanding the behavior of tablet disintegrants is valuable in the development of pharmaceutical solid dosage formulations. In this study, high-resolution magnetic resonance imaging has been used to understand the hydration behavior of a series of commercial sodium starch glycolate (SSG) samples, providing robust estimates of tablet disintegration rate that could be correlated with physicochemical properties of the SSGs, such as the extent of phosphorus (P) cross-linking as obtained from infra-red spectroscopy. Furthermore, elemental analysis together with powder X-ray diffraction has been used to quantify the presence of carboxymethyl groups and salt impurities, which also contribute to the disintegration behavior. The utility of Fast Low Angle SHot magnetic resonance imaging has been demonstrated as an approach to rapidly acquire approximations of the volume of a disintegrating tablet and, together with a robust voxel analysis routine, extract tablet disintegration rates. In this manner, a complete characterization of a series of SSG grades from different sources has been performed, showing the variability in their physicochemical properties and demonstrating a correlation between their disintegration rates and intrinsic characteristics. The insights obtained will be a valuable aid in the choice of disintegrant source as well as in managing SSG variability to ensure robustness of drug products containing SSG.

Original languageEnglish (US)
Pages (from-to)1907-1913
Number of pages7
JournalJournal of Pharmaceutical Sciences
Volume105
Issue number6
DOIs
StatePublished - Jun 1 2016

Keywords

  • FLASH MRI
  • disintegrants
  • imaging methods
  • infra-red spectroscopy
  • sodium starch glycolate
  • tablet disintegration
  • tablet imaging

ASJC Scopus subject areas

  • Pharmaceutical Science

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