A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01) A61K 9/50 (2006.01)
Patent
CA 2187898
Method for the preparation of a pharmaceutical composition in the form of microspheres controllably releasing at least one water soluble active ingredient. The method comprises the steps of dissolving the active ingredient in a suitable quantity of water; emulsifying the aqueous solution containing the active ingredient with a solution of at least a d,l-lactide-co-glycolide-type matrix copolymer in chlorinated hydrocarbon further containing a low molecular weight polyactide release modulating agent, which results in a first microfine and homogeneous emulsion; emulsifying the first emulsion thus obtained in an external aqueous phase, containing a surface active agent; and removing and evaporating the solvent to produce microspheres which are recovered after filtering, washing and drying.
L'invention concerne un procédé de préparation de composition pharmaceutique sous forme de microsphère à libération contrôlée d'au moins un principe actif hydrosoluble, caractérisé par la succession des étapes suivantes: dissolution du principe actif dans une quantité appropriée d'eau, émulsification de la solution aqueuse de principe actif ainsi obtenue avec une solution d'au moins un copolymère matriciel du type d,1-lactide-co-glycolide dams un hydrocarbure chlore contenant en outre un agent modulateur de libération polylactide de faible poids moléculaire, conduisant à une première émulsion microfine et homogène, émulsification de ladite première émulsion ainsi obtenue dans une phase aqueuse externe, contenant un agent tensio-actif, extraction-évaporation du solvant pour obtenir des microsphères que l'on récupère après filtration, lavage et séchage.
Arola Rosa
Asin Miguel Angel
Ferret Eulalia
Goutay Eric
Perez Amadeo
Ogilvy Renault Llp/s.e.n.c.r.l.,s.r.l.
Pierre Fabre Medicament
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