Piretanide polymorph, process for its preparation and its use

Details Piretanide polymorph, process for its preparation and its use Piretanide polymorph, process for its preparation and its use

C - Chemistry, Metallurgy

07

D

C07D 295/155 (2006.01) A61K 31/402 (2006.01) A61P 7/10 (2006.01)

Patent

CA 2614979

A piretanide polymorph having the following characteristics: a) an endothermic peak at about 132°C, b) an exothermic peak at about 143°C, and c) a melting peak at about 224°C in differential thermal curves; d) diffraction peaks (20) at 10.5, 12.2, 15.6, 19.1, 19.9, 22.0, 22.8, 25.6 and 30.6 in X-ray powder diffraction analysis; and e) characteristic absorption at around 1700 cm-1 and 3200-3500 cm-1 in infra-red absorption spectrum, and having a superior solubility around neutrality and a high bioavailability effective in the manner of oral or injection administration, which is prepared by dissolving piretanide in an aqueous solution of a base, adjusting a pH value of the solution to a pH range of less than 3.50 by an acid and recovering the precipitate thus separated, is described.

On décrit un polymorphe de pirétanide possédant les caractéristiques suivantes : a) pic endothermique à environ 132 degrés Celsius; b) pic exothermique à environ 143 degrés Celsius; c) pic de fusion à environ 224 degrés Celsius dans des cuves thermiques différentielles; d) pics de diffraction (20) à 10,5; 12,2; 15,6; 19,1; 19,9; 22,0; 22,8; 25,6; 30,6 en analyse par diffraction des rayons X sur poudre; e) absorption caractéristique autour de 1 700 cm-1 et entre 3 200 et 3 500 cm-1 en spectroscopie d'absorption dans l'infrarouge, et ayant en outre une solubilité supérieure aux pH proches de la neutralité ainsi qu'une biodisponibilité élevée lorsque administré par voie orale ou en injection, le produit étant alors préparé par dissolution du pirétanide dans une base en solution aqueuse, en ajustant le pH à une valeur inférieure à 3,50 par ajout d'un acide, puis par récupération du précipitat qui est ensuite séparé.

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