Methods for preparing nevirapine hemihydrate and an aqueous...

C - Chemistry – Metallurgy – 07 – D

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C07D 471/14 (2006.01) A61K 31/551 (2006.01) A61P 31/18 (2006.01)

Patent

CA 2617000

The invention relates to a method for preparing nevirapine hemihydrate and a method for preparing an aqueous suspension of nevirapine hemihydrate. The method for preparing nevirapine hemihydrate which method comprises the steps of: (a) treating an aqueous suspension of anhydrous nevirapine with a strong acid, to yield a solution of the acid addition salt; (b) treating the solution of the acid addition salt produced in the previous step with a strong base, to yield the free base of nevirapine as a precipitate, in the hemihydrate form; and, (c) separating the precipitated nevirapine hemihydrate from the aqueous medium by filtration; and, (d) washing the precipitated nevirapine hemihydrate produced in the previous step with water.

L'invention concerne une méthode permettant de préparer de l'hémihydrate de névirapine et une méthode permettant de préparer une suspension aqueuse d'hémihydrate de névirapine. La méthode permettant de préparer de l'hémihydrate de névirapine comporte les étapes suivantes : a) traitement d'une suspension aqueuse de névirapine anhydre au moyen d'un acide fort pour produire une solution contenant le sel d'addition acide; b) traitement de ladite solution contenant le sel d'addition acide au moyen d'une base forte pour produire la base libre de la névirapine sous forme de précipité hémihydraté; c) séparation de l'hémihydrate de névirapine précipité du milieu aqueux par filtration; et d) rinçage à l'eau de l'hémihydrate de névirapine précipité obtenu à l'étape précédente.

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