B - Operations – Transporting – 01 – J
Patent
B - Operations, Transporting
01
J
B01J 13/12 (2006.01) A61K 9/16 (2006.01) A61K 9/52 (2006.01)
Patent
CA 2053913
La présente invention a pour objet un procédé de préparation de microparticules de type microsphères d'une substance hydrosoluble et d'un polymère biocompatible et biodégradable contrôlant la cinétique de libération de ladite substance constituée d'une matrice dudit polymère au sein de laquelle est régulièrement dispersée ladite substance hydrosoluble, caractérisé en ce que: (a) ledit polymère est dissous dans un premier solvant organique volatile non miscible à l'eau; (b) ladite substance hydrosoluble est dissoute dans un second solvant qui est miscible audit premier solvant, est un solvant d'un polymère et miscible à l'eau; (c) on mélange la solution de ladite substance et la solution dudit polymère; (d) on obtient une phase organique du polymère et de ladite substance qui est ensuite émulsionnée dans un milieu non miscible dispersant, consistant en une phase aqueuse contenant un agent émulsifiant; (e) les deux solvants sont ensuite éliminés des microsphères en formation, sous agitation, le premier solvant étant éliminé par évaporation, le second solvant et une partie du premier solvantqui lui est miscible étant éliminés par passage vers la phase aqueuse par un mécanisme de séparation de phase; (f) après élimination des solvants, on récupère les microsphères formées éventuellement après lavage à l'eau et tamisage.
The object of the present invention is a process for preparing microparticles of the microsphere type of a water-soluble substance and a biocompatible and biodegradable polymer controlling the release kinetics of said substance, consisting of a matrix of said polymer within which said water-soluble substance is regularly dispersed, in which: (a) said polymer is dissolved in a first volatile organic solvent not miscible with waters (b) said water-soluble substance is dissolved in a second solvent miscible with the first, is a solvent of a polymer and miscible with waters (c) the solution of said substance and that of said polymer are mixed; (d) an organic phase of the polymer and said substance which is then emulsified in a non-miscible dispersant medium consisting of an aqueous phase containing an emulsifying agent; (e) the two solvents are then eliminated from the microspheres being formed, the first by evaporation and the second and a part of the first miscible therewith by transition to the aqueous phase by a phase separation mechanism; (f) alter the sovlents have been eliminated, the microspheres formed are recovered, possibly after washing in water and sieving.
Baudrihaye Marc
Delacroix Dominique
Mathieu Fabienne
Wantier Henri
Medgenix Group S.a.
Robic
Teva Pharmaceutical Industries Ltd.
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