Pharmaceutical composition and solid galenic form having a high dronedarone content, and method for preparing same

A technology for dronedarone and composition, applied in the field of pharmaceutical compositions and solid galenic forms with high dronedarone content and their preparation, to achieve the effects of avoiding drying steps, saving time, and being easy to swallow

Inactive Publication Date: 2014-04-30
SANOFI SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, some of the physical properties of dronedarone present considerable challenges in terms of developing formulations suitable for the preparation of the solid galenic form, namely an effective amount of the active substance in a capsule small enough to be easily swallowed. size combined

Method used

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  • Pharmaceutical composition and solid galenic form having a high dronedarone content, and method for preparing same
  • Pharmaceutical composition and solid galenic form having a high dronedarone content, and method for preparing same
  • Pharmaceutical composition and solid galenic form having a high dronedarone content, and method for preparing same

Examples

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Embodiment

[0107] The following examples describe the preparation of pharmaceutical compositions and galenic forms according to the invention. This example does not limit the invention and is only used to illustrate the invention.

[0108] Unless otherwise stated, the percentages of the compounds described below are expressed in weight percent relative to the total weight of the composition or galenic form in which the compound is located, as the case may be.

[0109] 1. Tablet composition of the present invention

[0110] By way of example, pharmaceutical composition 1A and pharmaceutical composition 1B of the present invention comprising only dronedarone hydrochloride as active substance are illustratively shown in Table 1 below.

[0111] The properties of the components in these compositions are shown in the table, together with the concentrations of the components (expressed in % by weight of the components relative to the total amount of the composition).

[0112] Table 1

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Abstract

The present invention relates to pharmaceutical compositions to be used, in a solid galenic form, for oral administration, and primarily including dronedarone and / or at least one of the derivatives thereof, as well as to solid galenic forms manufactured as such from said compositions, preferably in the form of tablets or capsules. The present invention also relates to a method for preparing such solid galenic forms using a hot-melt process.

Description

technical field [0001] The present invention relates to a pharmaceutical composition intended for use in a solid galenic form for oral administration, said composition essentially comprising dronedarone or at least one derivative thereof, and also to a pharmaceutical composition derived from said The compositions are prepared in solid galenical form, preferably tablets. The invention also relates to a process for preparing said solid galenic form on the basis of said pharmaceutical composition by the hot-melt route, and the invention also relates to the therapeutic use of said composition or said solid galenic form. Background technique [0002] Dronedarone or 2-n-butyl-3-[4-(3-di-n-butylaminopropoxy)benzoyl]-5-methylsulfonylaminobenzofuran is obtained by the following formula (I )express: [0003] [0004] Dronedarone and processes for its preparation are described in patents EP0471609B1 and US5223510. [0005] Dronedarone blocks potassium, sodium and calcium channels...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/12A61K47/32A61P9/06A61K47/30A61K31/343A61K47/02A61K47/10
CPCA61K31/343A61K9/1694A61K9/20A61K47/30A61K47/02A61K47/12A61K9/2027A61K47/10A61K47/32A61K9/2031A61P9/06
Inventor J.达卡索M.雷诺阿德
Owner SANOFI SA
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