Lercanidipine capsules

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/48 (2006.01) A61K 31/4422 (2006.01)

Patent

CA 2580525

A modified release pharmaceutical composition comprises lercanidipine dissolved in a waxy substance comprising a polyalcohol fatty acid ester, the solution being contained within a pharmaceutically acceptable capsule. Preferably the polyalcohol fatty acid ester is a polyethylene glycol ester, a polypropylene glycol ester, a fatty acid glyceride or a mixture of two or more thereof. Most preferably, the polyalcohol fatty acid ester is a mixture of mono-, di- and triglycerides and polyethylene glycol mono- and diesters. Oral administration of the modified release pharmaceutical compositions to a patient has been shown to result in a mean lercanidipine plasma concentration of greater than 0.5 ng/ml for 24 hours after administration.

L'invention a trait à une composition pharmaceutique à libération modifiée comprenant de la lercanidipine dissoute dans une substance cireuse contenant un ester d'acide gras polyalcool, la solution étant contenue à l'intérieur d'une gélule pharmaceutiquement acceptable. De préférence l'ester d'acide gras polyalcool est un ester de polyéthylèneglycol, un ester de polypropylèneglycol, un glycéride d'acide gras ou un mélange de deux de ces ingrédients ou davantage. Idéalement, l'ester d'acide gras polyalcool est un mélange de mono, di et triglycéride et de mono et diesters de polyéthylèneglycol. L'administration par voie orale des compositions pharmaceutiques à libération modifiée à un patient a démontré présenter une concentration moyenne de lercanidipine dans le plasma supérieure à 0,5 ng/ml pendant 24 heures après son administration.

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