Use of polyols to obtain stable polymorphous forms of rifaximin

A - Human Necessities – 61 – K

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A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 9/50 (2006.01) A61K 31/437 (2006.01) A61K 47/10 (2006.01) A61K 47/26 (2006.01) A61K 47/36 (2006.01) A61K 47/38 (2006.01)

Patent

CA 2645724

Polyols stabilize polymorphous form of rifaximin, in particular the .beta. form. When polyols having at least two hydroxy groups are added to rifaximin powder, polymorph .beta. is stable and remains stable in time independently from the environment humidity. In this invention a method to prepare formulations constituted by pure and stable polymorphous forms able to give a pharmaceutical product is described.

La présente invention concerne des polyols stabilisateurs de la forme polymorphe de rifaximine, notamment la forme .beta.. Lorsque des polyols ayant deux groupes hydroxy sont ajoutés à la poudre de rifaximine, la forme polymorphe .beta. est stable et demeure stable dans le temps indépendamment de l'humidité ambiante. L'invention concerne également un procédé de préparation de formulations constituées de formes polymorphes pures et stables permettant d'obtenir un produit pharmaceutique.

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