Fenofibrate formulation

摘要

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.

主权项

1. A dosage form comprising a plurality of beads or particles, each of said beads or particles having a coating, said coating comprising:
from 25% to 60% by weight of said beads or particles of a drug selected from the group consisting of fenofibric acid, pharmaceutically acceptable salts thereof, pharmaceutically acceptable esters thereof, and prodrugs thereof; from 0.3% to 10% by weight of said beads or particles of a surfactant; and from about 5% to about 15% by weight of said beads or particles of a water soluble or water dispersible cellulosic binder; wherein the mass ratio of said drug to said binder in said dosage form is between about 3.5:1 and 4.5:1; and wherein said 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 comprising said drug and said binder in a ratio of between about 5:1 and 15:1 and from 1% to 10% by weight of said surfactant; said dosage form and said comparative dosage form having the same amount of drug.