use of fenofibrate composition in a medicament to treat hypertriglyceridemia, hypercholesterolemia or hyperlipidemia while reducing the effect of diet on fenofibrate bioavailability

摘要

"fenofibrate-containing pharmaceutical composition and method for preparing it". The invention relates to the use of a fenofibrate composition containing micronized fenofibrate, a surfactant and a binding cellulose derivative as a solubilization aid, said composition containing an amount of fenofibrate greater than or equal to 60% by weight. for the preparation of a medicament for treating hypertriglyceridemia, hypercholesterolaemia or hyperlipidaemia while reducing the effect of diet on the bioavailability of fenofibrate. The invention is likewise related to an immediate release composition in the form of granules comprising: (a) a neutral core; (b) an active layer surrounding the core; and (c) an outer layer; wherein said active layer comprises micronized fenofibrate, a surfactant and a binding cellulose derivative; and wherein said composition has a dissolution profile of less than 10% in 5 minutes and greater than 80% in 20 minutes according to the European Pharmacopoeia in a dissolution medium consisting of water containing 0.025 m sodium lauryl sulfate. .