Mylan Gmbh

Forest Laboratories Holdings Limited

Andrew Alan Shaw

Sarat C Chattaraj

Glenn Allen Redelman

John P O'Donnell

R Preston Mason

Eric Davis

Peter Bruce Bottini

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

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.

Nebivolol has been shown to be beneficial in the treatment of cardiovascular diseases such hypertension, congestive heart failure, arterial stiffness and endothelial dysfunction. The present invention features a pharmaceutical composition comprising nebivolol and at least one other active agent, wherein the at least one other active agent is a cardiovascular agent.

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Morgantown, WV, United States of America

Andrew Alan Shaw