Polymer-based compositions for sustained release

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/50 (2006.01) A61K 9/16 (2006.01) A61K 38/24 (2006.01) A61K 47/34 (2006.01) B01J 13/02 (2006.01) A61K 9/19 (2006.01)

Patent

CA 2474698

This invention relates to sustained release compositions, and methods of forming and using said compositions, in particular for the sustained release of Follicle Stimulating Hormone (FSH). The sustained release compositions comprise a polymeric matrix of a biodegradable biocompatible polymer and stabilized FSH. The method of the invention for forming a sustained release composition includes, dissolving a biodegradable biocompatible polymer in a polymer solvent to form a polymer solution; adding biologically active stabilized FSH; removing the solvent; and solidifying the polymer to form a polymer matrix containing stabilized FSH dispersed therein. Also described is a method for providing a therapeutically effective amount of stabilized FSH in a patient in need of for a sustained period comprising administering to the patient a dose of the sustained release compositions of the invention. The sustained release composition of FSH can be used to promote maturation of follicles, promote spermatogenesis and to treat fertility disorders.

L'invention concerne des compositions à libération prolongée, ainsi que des méthodes de formation et d'utilisation desdites compositions. En particulier, l'invention concerne la libération prolongée d'hormones folliculostimulantes (FSH). Les compositions à libération prolongée comprennent une matrice polymère d'un polymère biocompatible biodégradable et des FSH stabilisées. La méthode permettant de former une composition à libération prolongée consiste à: dissoudre un polymère biocompatible biodégradable dans un solvant de polymère pour former une solution polymère; ajouter des FSH stabilisées actives; retirer le solvant; et solidifier le polymère pour former une matrice polymère contenant des FSH stabilisées dispersées dans cette matrice. L'invention concerne également une méthode permettant d'administrer une dose thérapeutiquement efficace de FSH stabilisées à un patient nécessitant cette hormone, pendant une période prolongée, consistant à administrer au patient une dose des compositions à libération prolongée. Cette composition à libération prolongée de FSH peut être utilisée pour favoriser la maturation de follicules, pour favoriser la spermatogenèse et pour traiter des troubles de la fertilité.

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