| Rapid Insight into Heating-Induced Phase Transformations in the Solid State of the Calcium Salt of Atorvastatin Using Multivariate Data Analysis. | |
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MedLine Citation:
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PMID: 23138263 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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PURPOSE: To investigate the heating-induced dehydration and melting behavior of the trihydrate phase of the calcium salt of atorvastatin. METHODS: Multivariate curve resolution (MCR) was used to decompose a variable-temperature synchrotron X-ray powder diffraction (VT-XRPD) data matrix into diffraction patterns and concentration profiles of pure drug phases. RESULTS: By means of the MCR-estimated diffraction patterns and concentration profiles, the trihydrate phase of the drug salt was found to dehydrate sequentially into two partially dehydrated hydrate structures upon heating from 25 to 110°C, with no associated breakage of the original crystal lattice. During heating from 110 to 140°C, the remaining water was lost from the solid drug salt, which instantly collapsed into a liquid crystalline phase. An isotropic melt was formed above 155°C. Thermogravimetric analysis, hot-stage polarized light microscopy, and hot-stage Raman spectroscopy combined with principal component analysis (PCA) was shown to provide consistent results. CONCLUSIONS: This study demonstrates that MCR combined with VT-XRPD is a powerful tool for rapid interpretation of complex dehydration behavior of drug hydrates, and it is also the first report on a liquid crystalline phase of the calcium salt of atorvastatin. |
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Authors:
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Niels Peter Aae Christensen; Bernard Van Eerdenbrugh; Kaho Kwok; Lynne S Taylor; Andrew D Bond; Thomas Rades; Jukka Rantanen; Claus Cornett |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-11-10 |
Journal Detail:
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Title: Pharmaceutical research Volume: - ISSN: 1573-904X ISO Abbreviation: Pharm. Res. Publication Date: 2012 Nov |
Date Detail:
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Created Date: 2012-11-9 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8406521 Medline TA: Pharm Res Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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