Journal article
Phase Transformation in Thiamine Hydrochloride Tablets: Influence on Tablet Microstructure, Physical Properties, and Performance
Journal of pharmaceutical sciences, Vol.101(4), pp.1410-1422
04/2012
DOI: 10.1002/jps.23020
PMID: 22213350
Abstract
The objective of this article was to monitor phase transformation in thiamine hydrochloride, from a nonstoichiometric hydrate (NSH) to a hemihydrate (HH), in stored tablets, prepared both by direct compression and wet granulation, and to relate the storage-induced phase transformation with changes in tablet microstructure, physical properties, and performance. Raman spectroscopy revealed complete NSH → HH transformation in tablets, within 30h of storage at 40°C/75% relative humidity. When the tablets were prepared by wet granulation of NSH alone, there was a marked increase in both tablet volume and hardness on storage. However, when microcrystalline cellulose (MCC) was included in granulation, the resulting stored tablets also exhibited a pronounced increase in disintegration time. In contrast, tablets prepared by dry processing via compression of a NSH–MCC physical mixture did not exhibit any changes in properties, despite the in situ solid form conversion. Scanning electron microscopy revealed growth of needle-like HH crystals in all stored tablets and mercury porosimetry revealed considerable changes in the pore size distribution during storage. Longer storage led to crystal growth (Ostwald ripening), causing further gradual but less dramatic changes in properties. The phase transformation and the complex interparticulate associations in the tablet influenced the changes in tablet microstructure, compact physical properties, and product behavior. © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association
Details
- Title: Subtitle
- Phase Transformation in Thiamine Hydrochloride Tablets: Influence on Tablet Microstructure, Physical Properties, and Performance
- Creators
- Paroma Chakravarty - Department of Pharmaceutics, University of Minnesota, Minneapolis, Minnesota 55455Raj Suryanarayanan - Department of Pharmaceutics, University of Minnesota, Minneapolis, Minnesota 55455Ramprakash Govindarajan - Product Development, GlaxoSmithKline, Research Triangle Park, North Carolina 27709
- Resource Type
- Journal article
- Publication Details
- Journal of pharmaceutical sciences, Vol.101(4), pp.1410-1422
- DOI
- 10.1002/jps.23020
- PMID
- 22213350
- NLM abbreviation
- J Pharm Sci
- ISSN
- 0022-3549
- eISSN
- 1520-6017
- Publisher
- Elsevier Inc
- Language
- English
- Date published
- 04/2012
- Academic Unit
- Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984065316002771
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