Shire Laboratories, Inc.

Scott A Ibrahim

Amir H Shojaei

Beth A Burnside

Likan Liang

Benjamin Thomas Kibalo

A fibrate self-emulsifying oral formulation with improved bioavailability when compared to commercially available formulations containing a therapeutically effective dose of fenofibrate, derivative of fenofibrate or mixtures thereof dissolved in a fibrate solubilizer selected from N-alkyl derivative of 2-pyrrolidone, mono- or di- or polyethylene glycol monoethers, Cfatty acid mono- or di-esters of propylene glycol, or combinations thereof, one or more surfactants and optionally one or more stabilizers useful in the treatment of hypercholesterolaemia or hypertriglyceridaemia in mammals in the fed or fasted state.

Self-emulsifying formulations of fenofibrate and/or fenofibrate derivatives with improved oral bioavailability and/or reduced food effect

A formulation for a stabilized capsule for oral administration of a hydrophobic pharmaceutically active agent; comprising a non-aqueous solubilizer selected from 2-pyrrolidone, N-alkylpyrrolidones and combinations thereof; and a capsule stabilizing agent selected from mono-, di- and triglycerides, mono- and di-fatty esters of polyethylene glycol, fatty acids and combinations thereof wherein capsule integrity is maintained for at least 24 hours is disclosed.

Oral capsule formulation with increased physical stability

Encapsulated oral dosage pharmaceutical products are produced utilizing a system including a hopper and a dosator, where the hopper receives particles having irregular geometries and sizes greater than about 100 &mgr;m for delivery to the dosator. A gaseous fluid is directed into the hopper to fluidize particles within the hopper so as to minimize or eliminate the formation of voids within the bed of particles disposed within the hopper. The fluidization of the particles within the hopper maintains a substantially continuous and uniform flow of particles from the hopper to the dosator, which results in the formation of encapsulated products with desirable weights and particle size distributions.

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Ellicott City, MD, United States of America

Scott A Ibrahim