Fenofibrate formulation with enhanced oral bioavailability

Details Fenofibrate formulation with enhanced oral bioavailability Fenofibrate formulation with enhanced oral bioavailability

A - Human Necessities

61

K

A61K 9/48 (2006.01) A61K 31/216 (2006.01)

Patent

CA 2729262

The present invention provides a formulation of fenofibrate with enhanced oral bioavailability, simplicity of design and manufacture and absence of food effect. The formulation comprises fenofibrate dissolved in a lipophilic surfactant, with a hydrophilic surfactant optionally added. The formulation can be effectively used in the management and treatment of conditions such as hypertriglyceridemia, hypercholesterolemia and mixed dyslipidemia, and can also be effective at lower doses as compared to commercially available products. The invention additionally relates to the process of manufacture of the formulation and to dosage forms comprising the same.

La présente invention porte sur une formulation de fénofibrate à biodisponibilité orale optimisée, de conception et de fabrication simples, et dépourvue d'effet alimentaire. La formulation renferme du fénofibrate dissous dans un tensioactif lipophile, un tensioactif hydrophile pouvant éventuellement être ajouté. La formulation peut être utilisée efficacement dans la gestion et le traitement d'états pathologiques tels que l'hypertriglycéridémie, l'hypercholestérolémie et la dyslipidémie mixte, et se révèle en outre efficace à des doses inférieures par rapport aux produits disponibles dans le commerce. L'invention porte en outre sur le procédé de fabrication de la formulation, ainsi que sur des formes posologiques la renfermant.

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