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|Title:||Methods of use of fenofibric acid|
|Abstract:||Fenofibric acid formulations comprising 105 mg of fenofibric acid are described as well as methods of use thereof. Dosage forms include, for example, immediate-release dosage forms.|
|Inventor(s):||Arnold; Kristin Anne (Morrisville, PA), Feng; Hengsheng (Cherry Hill, NJ)|
|Assignee:||Mutual Pharmaceutical Company, Inc. (Philadelphia, PA)|
|Patent Claims:||1. A method of treating a human patient in need of treatment for primary hypercholesterolemia, hypertriglyceridemia, mixed dyslipidemia, or mixed hyperlipidemia, comprising orally administering to the patient once daily an immediate-release 105 mg fenofibric acid dosage form, wherein the dosage form comprises 1 wt % to 30 wt % of a disintegrant, 30 wt % to 90 wt % of a filler, 0.1 wt % to 20 wt % of a binder, and 0.01 wt % to 10 wt % of a lubricant, and wherein the dosage form does not include an enteric binder and does not include a surfactant, wherein the 105 mg fenofibric acid dosage form is bioequivalent to a 145 mg fenofibrate dosage form under fasted and standard or low-fat meal non-fasted conditions, wherein the fenofibrate dosage form comprises particles of fenofibrate having an effective average particle size of less than about 2000 nm and having associated with the surface thereof a surface stabilizer comprising hypromellose, sodium lauryl sulfate and dioctyl sodium sulfosuccinate.|
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