Document Detail


Solid-state characterization and dissolution properties of Fluvastatin sodium salt hydrates.
MedLine Citation:
PMID:  23033850     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The present study reports the solid-state properties of Fluvastatin sodium salt crystallized from different solvents for comparison with crystalline forms of the commercially available raw material and United States Pharmacopeia (USP) reference standard. Fluvastatin (FLV) samples were characterized by several techniques; such as X-ray powder diffractometry, differential scanning calorimetry, thermogravimetry, liquid and solid-state nuclear magnetic resonance spectroscopy, diffuse reflectance infrared Fourier transform spectroscopy, and scanning electron microscopy. In addition, intrinsic dissolution rate (IDR) of samples was performed in order to study the influence of crystalline form and other factors on rate and extent of dissolution. Three different forms were found. The commercial raw material and Fluvastatin-Acetonitrile (ACN) were identified as "form I" hydrate, the USP reference standard as "form II" hydrate and an ethanol solvate which presented a mixture of phases. Form I, with water content of 4%, was identified as monohydrate.
Authors:
Silvia H M Borgmann; Larissa S Bernardi; Gabriela S Rauber; Paulo R Oliveira; Carlos E M Campos; Gustavo Monti; Silvia L Cuffini; Simone G Cardoso
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-4
Journal Detail:
Title:  Pharmaceutical development and technology     Volume:  -     ISSN:  1097-9867     ISO Abbreviation:  Pharm Dev Technol     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9610932     Medline TA:  Pharm Dev Technol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Federal University of Santa Catarina , Florianópolis , Brazil.
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