Mylan Gmbh

Glenn Allen Redelman

Sarat C Chattaraj

Andrew Alan Shaw

Various fenofibrate dosage forms contain a plurality of beads or particles, where the beads or particles include a pharmaceutical composition comprising fenofibrate; from 0.3% to 10% by weight of the beads or particles of a surfactant; and from about 5% to about 15% by weight of the beads or particles of a water soluble or water dispersible cellulosic binder. The mass ratio of the drug to the binder in the dosage form is between about 3.5:1 and 4.5:1; and the dosage form produces a first Cmax in vivo that is between about 10% and about 50% higher than a comparative Cmax produced by a comparative dosage form. The comparative dosage form comprises the drug and the binder in a ratio of between about 5:1 and 15:1. The dosage form may contain a plurality of beads or particles, each of the beads or particles including a pharmaceutical composition containing from about 20% to about 55% by weight of fenofibrate; from 0.3% to 10% by weight of a surfactant; and from about 5% to about 15% by weight of a water soluble or water dispersible cellulosic binder.

Fenofibrate formulation

Embodiments of liquid-filled hard gel capsule pharmaceutical formulations comprise a non-emulsified mixture, wherein the non-emulsified mixture comprises about 0.1 to about 5% by weight of at least one active pharmaceutical ingredient, about 50 to about 95% by weight medium chain triglycerides, and about 5 to about 25% by weight medium chain mono/diglycerides, wherein the medium chain triglycerides and medium chain mono/diglycerides are present at a ratio by weight of from about 10:1 to about 5:1.

Liquid-filled hard gel capsule pharmaceutical formulations

Various fenofibrate dosage forms contain a plurality of beads or particles, where the beads or particles include a pharmaceutical composition comprising fenofibrate; from 0.3% to 10% by weight of the beads or particles of a surfactant; and from about 5% to about 15% by weight of the beads or particles of a water soluble or water dispersible cellulosic binder. The mass ratio of the drug to the binder in the dosage form is between about 3.5:1 and 4.5:1; and the dosage form produces a first Cmax in vivo that is between about 10% and about 50% higher than a comparative Cmax produced by a comparative dosage form. The comparative dosage form comprises the drug and the binder in a ratio of between about 5:1 and 15:1.

Various fenofibrate compositions include a plurality of first granules having a high bioavailability in vivo, and a plurality of second granules having a low bioavailability in vivo. The first granules may comprise fenofibrate, from 0.3% to 10% by weight of the first granules of a first surfactant, and a first water soluble or water dispersible cellulose derivative, and the second granules may comprise fenofibrate, from 0% to 0.25% by weight of the second granules of a second surfactant, and a second water soluble or water dispersible cellulose derivative.

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Morgantown, WV, United States of America

Glenn Allen Redelman