Structural and Analytical Characterization of Three Hydrates and an Anhydrate Form of Risedronate

Characterization of a New Solvate of Risedronate

“…About 10 to 15 mg of the best samples of each phase was filled into corundum crucibles and heated from room temperature to 300 • C at 3 K/min under nitrogen atmosphere. The results corresponded to those in the literature28,29,31,32 for the known phases. Additionally, for form J DSC measurements were made on a SETARAM (DSC 131) device (SETARAM, Caluire, France).…”

“…All samples were measured at room temperature. X-ray powder diffraction patterns were recorded and examined for polymorphs and solvates by comparing with the powder patterns in Redman-Furey et al and Gossman et al 31,32 …”

“…Here, we follow the phase nomenclature of Cazer et al 28 and Aronhime et al 29 These patents 28 hemi-pentahydrate, and variable hydrate) and an anhydrate of sodium risedronate have been elucidated and discussed by Redman-Furey et al 31 and Gossman et al 32 The most stable of all these forms at ambient conditions (298 K, 50% RH) is the sodium hemipentahydrate, which is the marketed form. 28 Table 3 gives a listing of polymorphs, chemical compositions, space groups, lattice parameters, and indicates the method of structure determination (X-ray single crystal or powder diffraction).…”

X-ray and Neutron Diffraction in the Study of Organic Crystalline Hydrates

“…However, if the powder pattern can be indexed and the asymmetric unit does not present major difficulties (large size, more than one molecule, molecules on special positions like mirror planes, rotation axes or inversion centres), the crystal structure can be relatively quickly solved and refined from powder data. One successful example is risedronate sodium anhydrate (C 7 H 10 NO 7 P 2 Na) [59]. The complexity of the problem is significantly increased for hydrates since the presence of the water molecule(s) significantly increases the number of degrees of freedom of the system.…”

Investigation of Carbohydrates and Their Derivatives as Crystallization Modifiers

“…Ten different polymorphic and pseudo-polymorphic forms of sodium risedronate (V) identified as A, B, B1, BB, D, E, F, G and H and a semi-crystalline form were described (Cazer et al, 2001;Aronhime et al, 2003a;Aronhime et al, 2003b;Richter et al, 2007). The crystal structures of four different hydrates (monohydrate, dihydrate, hemipentahydrate and variable hydrate) and an anhydrate of sodium risedronate (V) have been elucidated and discussed by Redman-Furey (Redman-Furey et al, 2005) and Gossman (Gossman et al, 2003). Recently three new phases were found and named J, K and M (Bruning et al, 2011).…”