|Title:||Reduced dose pharmaceutical compositions of fenofibrate|
|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.|
|Inventor(s):||Kallem; Venkat Reddy (Hyderabad, IN), Kasu; Raghu Rami Reddy (Maharashtra, IN), Das; Subhasis (Maharashtra, IN), Thommandru; Vijaya Kumar (Maharashtra, IN)|
|Assignee:||Lupin Atlantis Holdings, S.A. (Schaffhausen, CH)|
1. 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.RTM. 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.
2. The pharmaceutical composition of claim 1 which is substantially free of food effect.
3. The pharmaceutical composition of claim 1 wherein the composition is formulated into a dosage form selected from the group consisting of tablets and capsules.
4. The pharmaceutical composition of claim 1, wherein nanoparticulate fenofibrate has an effective particle size of about 1 nm to about 950 nm.
5. The pharmaceutical composition of claim 1, wherein micronized fenofibrate has an effective particle size of about 1 .mu.m to about 50 .mu.m.
6. A method of treating a patient for primary hyperlipidemia, hypercholesterolemia, and/or hypertriglyceridemia comprising administering to the patient in need thereof an effective amount of the pharmaceutical composition of claim 1.
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