Correlation of Phosphorus Cross-Linking to Hydration Rates in Sodium Starch Glycolate Tablet Disintegrants Using MRI
| Autor: | Rao V. Mantri, Alexej Jerschow, Dolapo Olusanmi, Daniel McNamara, Andrew J. Ilott, David Good, Murphy Denette K, Anuji Abraham |
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| Rok vydání: | 2016 |
| Předmět: |
Materials science
Spectrophotometry Infrared Analytical chemistry Pharmaceutical Science chemistry.chemical_element 02 engineering and technology 030226 pharmacology & pharmacy Excipients 03 medical and health sciences 0302 clinical medicine X-Ray Diffraction Sodium Starch Glycolate Infra red spectroscopy Chromatography Phosphorus Starch 021001 nanoscience & nanotechnology Magnetic Resonance Imaging Cross-Linking Reagents Solubility chemistry Elemental analysis 0210 nano-technology Disintegration Rate Tablets |
| Zdroj: | Journal of Pharmaceutical Sciences. 105:1907-1913 |
| ISSN: | 0022-3549 |
| DOI: | 10.1016/j.xphs.2016.03.025 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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