Solid-state characterization and dissolution properties of Fluvastatin sodium salt hydrates.

Abstract:

: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.

journal_name

Pharm Dev Technol

authors

Borgmann SH,Bernardi LS,Rauber GS,Oliveira PR,Campos CE,Monti G,Cuffini SL,Cardoso SG

doi

10.3109/10837450.2012.727000

subject

Has Abstract

pub_date

2013-03-01 00:00:00

pages

525-34

issue

2

eissn

1083-7450

issn

1097-9867

journal_volume

18

pub_type

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