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Characterization and quantification of amorphous material in milled and spray-dried salbutamol sulfate: A comparison of thermal, spectroscopic, and water vapor sorption approaches

Grisedale, L.C., Jamieson, M.J., Belton, P.S., Barker, S.A., Craig, D.Q.M. (2011) Characterization and quantification of amorphous material in milled and spray-dried salbutamol sulfate: A comparison of thermal, spectroscopic, and water vapor sorption approaches. Journal of Pharmaceutical Sciences, 100 (8). pp. 3114-3129. ISSN 0022-3549. (doi:10.1002/jps.22484) (The full text of this publication is not currently available from this repository. You may be able to access a copy if URLs are provided) (KAR id:78851)

The full text of this publication is not currently available from this repository. You may be able to access a copy if URLs are provided. (Contact us about this Publication)
Official URL
https://doi.org/10.1002/jps.22484

Abstract

A study has been undertaken using a range of established and novel approaches to examine the effects of milling on the structure and crystallization behavior of salbutamol sulfate. A combination of modulated temperature differential scanning calorimetry, attenuated total reflectance Fourier-transform infrared spectroscopy, powder X-ray diffraction, and gravimetric vapor sorption analysis have been employed, with a particular view to examining the validity of using spray-dried material as a comparator. Although the expected increase in amorphization with milling time was observed, several unexpected observations were made including an apparently anomalous relationship between glass transition temperature and water content; this was used as the basis for the development of a novel method of quantifying amorphous content. Reasonable agreement was found between the data obtained from the spectroscopic and thermal methods, particularly those latter approaches that do not rely on recrystallization for quantification. The activation energy for the onset process was determined and found to be similar for all materials studied. The study has indicated that when using spray-dried material as a standard, the associated limitations must be appreciated, particularly in terms of the assumption of comparability of the recrystallization process between materials that is embedded in many quantification techniques.

Item Type: Article
DOI/Identification number: 10.1002/jps.22484
Uncontrolled keywords: Amorphous, Crystallinity, Materials science, Milling, Thermal analysis, salbutamol sulfate, amorphous material, article, crystallization, device, differential scanning calorimetry, drug manufacture, drug structure, glass transition temperature, gravimetry, infrared spectroscopy, intermethod comparison, material state, materials, milling, quantitative analysis, spectrometer, spray drying, water content, water vapor, X ray powder diffraction
Divisions: Faculties > Sciences > Medway School of Pharmacy
Depositing User: Susan Barker
Date Deposited: 27 Nov 2019 10:21 UTC
Last Modified: 27 Nov 2019 10:21 UTC
Resource URI: https://kar.kent.ac.uk/id/eprint/78851 (The current URI for this page, for reference purposes)
Barker, S.A.: https://orcid.org/0000-0003-4880-0253
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