| Investigation of solution and vapor phase mediated phase transformation in thiamine hydrochloride. | |
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MedLine Citation:
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PMID: 20575002 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Thiamine hydrochloride (THCl) can exist as an anhydrate (AH), a hemihydrate (HH) and as a nonstoichiometric hydrate (NSH) where the water content can range between 0 and approximately 1 mole of water per mole of THCl. We have investigated the NSH --> HH phase transformation, in the presence of microcrystalline cellulose (MCC), following (i) wet massing, (ii) fluid-bed granulation, and (iii) exposure to water vapor (40 degrees C/75% RH). Based on Raman spectroscopy (40 degrees C), wet massing of NSH alone caused near complete transformation to HH in <100 min. In the presence of MCC, the transformation rate was decelerated. During fluid-bed granulation, approximately 20% of NSH was transformed to HH and the deceleratory effect of MCC was much less pronounced. Exposure to water vapor, of both NSH-MCC powder blends and granules (prepared by fluid-bed) resulted in complete HH formation within 6 days. Presence of MCC in the powder blend did not affect HH formation kinetics, but facilitated phase transformation in the granules. NSH --> HH conversion appeared to follow two-dimensional nucleation and growth model in powder blends, whereas the granules showed either three-dimensional diffusion controlled or a first-order kinetics. In a wet mass, polyvinyl pyrrolidone, a widely used binder, was much more effective than MCC in inhibiting HH formation during wet massing. |
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Authors:
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Paroma Chakravarty; Ramprakash Govindarajan; Raj Suryanarayanan |
Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S. |
Journal Detail:
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Title: Journal of pharmaceutical sciences Volume: 99 ISSN: 1520-6017 ISO Abbreviation: J Pharm Sci Publication Date: 2010 Sep |
Date Detail:
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Created Date: 2010-07-28 Completed Date: 2010-11-26 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 2985195R Medline TA: J Pharm Sci Country: United States |
Other Details:
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Languages: eng Pagination: 3941-52 Citation Subset: IM |
Affiliation:
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Department of Pharmaceutics, University of Minnesota, Minneapolis, Minnesota 55455, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Cellulose
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chemistry Phase Transition Powder Diffraction Solubility Thiamine / chemistry* Water / chemistry* X-Ray Diffraction |
| Chemical | |
Reg. No./Substance:
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0/microcrystalline cellulose; 59-43-8/Thiamine; 7732-18-5/Water; 9004-34-6/Cellulose |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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