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Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof

A fenofibric acid and preparation technology, applied in the field of oral administration of fenofibric acid to its physiologically acceptable salt or derivatives, can solve problems such as recrystallization and reduction of drug bioavailability

Inactive Publication Date: 2009-07-15
ABBOTT GMBH & CO KG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the insolubility of fenofibrate in water, the substance has a tendency to recrystallize during release from the formulation
This may reduce the bioavailability of the drug

Method used

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  • Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof
  • Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0143] Fenofibrate (120g, equivalent to 15% w / w), HP 55 S (hydroxypropylmethylcellulose phthalate, ShinEtsu, 672g, equivalent to 84% w / w) and colloidal Silica (Aerosil 200, 8 g, corresponding to 1% w / w) was mixed in a turbulent mixer for 4 minutes. The powder mixture was then extruded in a twin-screw extruder (screw diameter 18 mm) at a feed rate of 1.0 kg / h at a melt temperature of 165°C. A clear, transparent rope-like melt with a thickness of approximately 1.0 cm was extruded. The material is directly formed into tablets (oval shape) by calendering between two co-rotating rollers. High hardness clear, transparent tablets with a tablet weight of about 550 mg are obtained by this method.

Embodiment 2

[0145] The tablets of Example 1 were milled in a laboratory mill and the resulting powder was analyzed by DSC between 20 and 250° C. (Mettler Toledo DSC-820; 8.45 mg in closed pan, 10 K / min). No endothermic melting peak was observed, indicating that fenofibrate exists in the polymer backbone in an amorphous form.

Embodiment 3

[0147] The powder obtained by grinding the tablet of Example 2 was subjected to WAXS (Wide Angle X-ray Scattering; Bruker AXS D-5005) analysis. No distinct peaks were seen in WAXS, indicating the absence of crystalline fenofibrate in this formulation.

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Abstract

In one aspect, the present invention relates to a formulation in the form of molecular dispersion comprising i) fenofibric acid, a physiologically acceptable salt or derivative thereof and optionally other active substances, ii) a binder component comprising at least one enteric binder, and optionally iii) other physiologically acceptable excipients. In a second aspect, the present invention relates to novel salts of fenofibric acid that are photostable when compared to other salts of fenofibric acid.

Description

[0001] This application is a divisional application of PCT application PCT / EP2003 / 014331 filed on December 16, 2003 with the title of the invention "Preparation comprising fenofibric acid, its physiologically acceptable salt or derivative", said PCT The date of the application to enter the Chinese national phase is June 17, 2005, and the application number is 200380106526.8. technical field [0002] The present invention relates to formulations comprising fenofibric acid, physiologically acceptable salts or derivatives thereof, processes for the preparation of said formulations, in particular by melt extrusion, and these formulations for oral administration of fenofibric acid , the use of its physiologically acceptable salt or derivative. Background technique [0003] Fenofibrate is a well known lipid modulator that has been on the market for a long time. [0004] Fenofibrate is generally administered orally. After its absorption, which is known to occur in the duodenum an...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61K31/205A61K47/30A61K47/38A61K9/20A61K9/48A61P43/00A61K9/14A61K9/16A61K31/216A61K31/495A61K31/56A61K31/58
CPCA61K31/56A61K9/1652A61K9/2054A61K31/216A61K31/192A61K31/495A61K9/146A61K31/205A61K31/58A61P3/06
Inventor J·罗森波格M·德根哈特J·布赖滕巴赫T·L·赖兰K·C·马什
Owner ABBOTT GMBH & CO KG
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