title: 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.
authors.affiliation: Federal University of Santa Catarina, Florianópolis, Brazil.
authors.forename: Silvia H M
authors.initials: SH
authors.lastname: Borgmann
authors.forename: Larissa S
authors.initials: LS
authors.lastname: Bernardi
authors.forename: Gabriela S
authors.initials: GS
authors.lastname: Rauber
authors.forename: Paulo R
authors.initials: PR
authors.lastname: Oliveira
authors.forename: Carlos E M
authors.initials: CE
authors.lastname: Campos
authors.forename: Gustavo
authors.initials: G
authors.lastname: Monti
authors.forename: Silvia L
authors.initials: SL
authors.lastname: Cuffini
authors.forename: Simone G
authors.initials: SG
authors.lastname: Cardoso
mesh_terms: D002152:Calorimetry, Differential Scanning / Q000379:methods; D003460:Crystallization / Q000379:methods; D005229:Fatty Acids, Monounsaturated / Q000737:chemistry*; D000077340:Fluvastatin; D007211:Indoles / Q000737:chemistry*; D009682:Magnetic Resonance Spectroscopy / Q000379:methods; D008855:Microscopy, Electron, Scanning / Q000379:methods; D012995:Solubility; D012997:Solvents / Q000737:chemistry; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods; D013818:Thermogravimetry / Q000379:methods; D014961:X-Ray Diffraction / Q000379:methods
chemical_list: D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D012997:Solvents; D000077340:Fluvastatin