Reduced dose pharmaceutical compositions of fenofibrate
AssigneeLupin Atlantis Holdings SA
InventorsVenkat Reddy Kallem, Raghu Rami Reddy Kasu, Subhasis Das, Vijaya Kumar Thommandru
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Abstract
The present invention provides a reduced dose oral pharmaceutical composition comprising mixture of nanoparticulate fenofibrate and micronized fenofibrate and one or more pharmaceutically acceptable excipients.
Claims6
An oral pharmaceutical composition comprising fenofibrate, wherein the composition comprises a mixture of nanoparticulate fenofibrate and micronized fenofibrate and one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is a solid, the ratio of the nanoparticulate fenofibrate to the micronized fenofibrate is 50:50 wt/wt, and the pharmaceutical composition includes a dosage of about 90 mg of fenofibrate, wherein the composition is bioequivalent to ANTARA® capsule containing 130 mg of micronized fenofibrate particles, wherein the bioequivalence of the composition is established by:
- (i) a 90% Confidence Interval for AUC which is between 0.80 and 1.25;
- and (ii) a 90% Confidence Interval for CmnaX, which is between 0.80 and 1.25 under fasting condition.
Dependencies are inferred from the claim text.