REDUCED DOSE ORAL PHARMACEUTICAL COMPOSITIONS OF FENOFIBRATE
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United States of America Patent
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Issued Date -
May 9, 2013
app pub date -
Jan 13, 2012
filing date -
Nov 5, 2011
priority date (Note) -
Abandoned
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Abstract
The invention relates to reduced dose oral pharmaceutical composition of fenofibrate which exhibits substantial bioequivalence to Antara® Capsules under fasting condition and also capable of reducing the food effect on bioavailability of fenofibrate. Provided is a pharmaceutical composition comprising about 90 mg of fenofibrate particles having a D90 particle size of less than about 600 nm and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is a solid dosage form suitable for oral administration and is substantially free of food effect such that when administered orally to a human provides an AUC0-t value for fenofibric acid in the blood plasma of the human under a fed state which is higher than the AUC0-t value under a fasted state by up to 12%, wherein t is 96 hours from the administration of the pharmaceutical composition.
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