Compositions of allosteric hemoglobin modifiers and methods...

C - Chemistry – Metallurgy – 07 – C

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Details

C07C 261/00 (2006.01) A61K 31/40 (2006.01) C07C 69/76 (2006.01) C07C 229/00 (2006.01)

Patent

CA 2563752

ABSTRACT The present invention provides novel compositions of allosteric hemoglobin modifiers which are substantially free of impurities, specifically polymeric impurities. In one embodiment, the novel compositions contain an allosteric hemoglobin modifier compound and less than 100 ppm of the polymeric impurities generated during the preparation of this compound. Included in the present invention are novel methods for preparing allosteric hemoglobin modifiers that are substantially free of polymeric impurities. Also included in the present invention are improved methods for the purification of the product formed by the method of this invention. The novel methods of purification comprise extracting the crude composition with a water immiscible or partially immiscible solvent such as methylisobutyl ketone (MIBK) to lower amounts of impurities, specifically polymeric impurities. Also included are methods to reduce impurities by recrystallization of the crude synthesized product, followed by filtration of the recrystallized product. The present invention also includes the products made by the processes of the invention and methods for analyzing compositions comprised of these products.

La présente invention porte sur de nouvelles compositions de modificateurs d'hémoglobine allostériques qui sont quasiment exempts d'impuretés, notamment d'impuretés polymères. Selon une forme de réalisation, les nouvelles compositions contiennent un composé du modificateur d'hémoglobine allostérique et moins de 100 ppm des impuretés polymères générées pendant la préparation de ce composé. L'invention porte également sur de nouveaux procédés de préparation des modificateurs d'hémoglobine allostériques qui sont quasiment exempts d'impuretés polymères, et sur des procédés améliorés de purification du produit obtenu selon cette invention. Les nouveaux procédés de purification consistent à extraire la composition brute avec un solvant immiscible ou partiellement immiscible dans l'eau tel que le méthylisobutyl cétone (MIBK) afin de réduire les quantités d'impuretés, notamment les impuretés polymères. L'invention porte également sur des procédés visant à réduire les impuretés par recristallisation du produit synthétisé brut, puis par filtration du produit recristallisé. L'invention porte notamment sur les produits obtenus par ces processus et sur des procédés d'analyse de compositions comprenant ces produits.

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