Tablet comprising a fibrate
AssigneeVeloxis Pharmaceuticals A/S
InventorsPer Holm, Tomas Norling
Life of this patent
Estimating the term…
Abstract
Stable tablets and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved or dispersed in an non-aqueous vehicle with improved bioavailability, thereby eliminating the food effect so that the tablet or composition can be administered to a patient irrespective of being in fed or fasted state.
Claims21
A tablet comprising 33, 37, 40, 43, 48, 87, 100, 110, 120, 130, 145, or 160 mg fenofibrate in a hydrophilic vehicle, the vehicle comprising an effective amount of poloxamer and a hydrophilic polymer such that the tablet, upon oral administration to a patient in need thereof, results in a value of AUCfasted relative to a value of AUCfed of at least about 0.85 with a lower 90% confidence limit of at least 0.75.
A tablet comprising a solid dispersion or solid solution of fenofibrate in a vehicle, the vehicle comprising (i) polyethylene glycol having an average molecular weight of 3000 daltons to 35000 daltons and (ii) poloxamer in a weight proportion of between 1:3 and 10:1, wherein the tablet upon oral administration to a patient in need thereof results in a value of AUCfasted relative to a value of AUCfed of at least about 0.85 with a lower 90% confidence limit of at least 0.75.
A tablet comprising 40 or 120 mg fenofibrate in a hydrophilic vehicle, wherein the fenofibrate and hydrophilic vehicle are on a solid carrier, and the vehicle comprises an effective amount of poloxamer and a hydrophilic polymer such that the tablet, upon oral administration to a patient in need thereof, results in a value of AUCfasted relative to a value of AUCfed of at least about 0.85 with a lower 90% confidence limit of at least 0.75.
Dependencies are inferred from the claim text.