A solid dosage form comprising a fibrate

Abstract

The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.

Description

[0001] The present invention relates to novel solid dosage forms and pharmaceutical compositions comprising fibrates, especially fenofibrate. In particular the present invention discloses solid dosage forms with increased bioavailability. Solid dosage forms of the invention comprise fibrate dissolved in a suitable vehicle or mixture of vehicles. Said dosage forms are particularly suitable for oral administration and exhibit excellent storage stability, ie are stable. The invention also relates to processes for the preparation of said solid dosage forms and pharmaceutical compositions and uses thereof. Background of the invention [0002] Fibrate is a lipid regulator. Examples of fibrates include gemfibrozil, fenofibrate, bezafibrate, clofibrate, and ciprofibrate. The compounds are considered prodrugs and are metabolized in vivo to produce their active metabolites. For illustrative purposes only, the following is based on a specific example of fibrate, namely fenofibrate. ...

AI Technical Summary

Problems solved by technology

However, there remains a need for improved dosage forms relative to currently available compositions and dosage forms that provide crystalline fenofibrate in micronized form

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