Process for the preparation of a stable dispersion of...

A - Human Necessities – 61 – K

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A61K 9/10 (2006.01)

Patent

CA 2618468

The present invention relates to a process for the preparation of a stable dispersion of particles, particularly sub-micron particles in an aqueous medium and to a stable dispersion of particles in a liquid medium. The process provided comprises the following steps: 1) combining a) an emulsion comprising a continuous aqueous phase; an inhibitor; a stabiliser; with b) the substantially water-insoluble substance; and 2) increasing the temperature to vicinity of the melting temperature of the substantially water-insoluble substance. The sub-micron dispersion provided exhibit reduced or substantially no particle growth during storage and reduced crystallisation rate of the substantially water insoluble active compound.

La présente invention concerne un processus de préparation d~une dispersion stable de particules, en particulier de particules submicroniques dans un milieu aqueux et de dispersion stable de particules dans un milieu liquide. Le processus comprend les étapes suivantes : 1) combinaison a) d~une émulsion comportant une phase aqueuse continue ; un inhibiteur ; un stabilisateur ; avec b) la substance sensiblement insoluble dans l~eau ; et 2) l'augmentation de la température au voisinage de la température de fonte de la substance sensiblement insoluble dans l~eau. La dispersion submicronique objet de l'invention présente une croissance de particules réduite ou sensiblement nulle pendant le stockage et un taux de cristallisation réduit du composé actif sensiblement insoluble dans l~eau.

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