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A solid dosage form comprising a fibrate

A technology of fenofibrate and tablets, applied in the field of solid dosage forms containing fibrate

Active Publication Date: 2009-10-21
VELOXIS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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  • A solid dosage form comprising a fibrate
  • A solid dosage form comprising a fibrate
  • A solid dosage form comprising a fibrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0236] Immediate release tablet with enhanced bioavailability

[0237] Fenofibrate was dissolved in polyethylene glycol 6000 and poloxamer 188 (70:30 w / w ratio) at a concentration of 17% at 75°C. 244 g of the melted solution were sprayed on 200 g of lactose in fluidized bed Strea-1 at 75°C. The granulated product was screened through a 0.7 mm sieve and mixed with magnesium stearate in a Turbula mixer for 0.5 minutes. The mixture was compressed into 10 mm tablets of 50 mg strength (540 mg tablet with compound cup shaped).

[0238] substance

[0239] Average disintegration time: 26 minutes, hardness: 45N

Embodiment 2

[0241] Immediate release tablet with enhanced bioavailability

[0242] As described in Example 1, 10 mm tablets of 50 mg strength (540 mg cup-shaped tablets with compound) and the following composition were prepared:

[0243] substance

[0244] Average disintegration time: 21 minutes, hardness: 55N

Embodiment 3

[0246] Immediate release tablet with enhanced bioavailability

[0247] As described in Example 1, 10 mm tablets of 50 mg strength (540 mg cup-shaped tablets with compound) and the following composition were prepared:

[0248] substance

[0249] Average disintegration time: 22 minutes, hardness: 48N

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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 fibrate, in particular fenofibrate. In particular, the present invention discloses solid dosage forms with increased bioavailability. The solid dosage forms of the present invention comprise fibrate dissolved in a suitable vehicle or vehicle mixture. The dosage form is particularly suitable for oral administration and exhibits excellent storage stability, ie is stable. The invention also relates to methods and uses for the preparation of said solid dosage forms and pharmaceutical compositions. Background of the Invention [0002] Bethes are lipid regulators. Examples of fibrates include gemfibrozil, fenofibrate, bezafibrate, clofibrate, and ciprofibrate. The compounds are considered prodrugs, which are metabolized in vivo to produce their active metabolites. For illustrative purposes only, the following is based on a specific bate example, fenofibrate. Fenofibrate i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/216A61K31/192A61K31/195A61K9/20A61K47/02A61K47/10A61K47/14A61K47/26A61K47/44A61P3/06A61K47/06A61K47/12
Inventor P·霍尔姆T·诺林
Owner VELOXIS PHARMA