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Fexofenadine suspension formulation

A technology for fexofenadine and suspensions, which is applied in the field of aqueous suspension preparations and can solve problems such as no disclosure content

Active Publication Date: 2008-12-03
SANOFI AVENTIS US LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there is no disclosure regarding the aqueous suspension formulation of fexofenadine or the zwitterionic dihydrate crystalline form of fexofenadine

Method used

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  • Fexofenadine suspension formulation
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  • Fexofenadine suspension formulation

Examples

Experimental program
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Embodiment approach

[0043] Regarding the invention described herein, the following are specific embodiments related to it.

[0044] A specific embodiment of the present invention is the aqueous pharmaceutical suspension, wherein the preservative system further comprises about 0.06% to about 0.26% of disodium edetate, about 0.01% to about 0.27% of benzoic acid or sodium benzoate , About 0.01% to about 0.30% sorbic acid or potassium sorbate or about 0.10% to about 1.50% benzyl alcohol.

[0045] Another specific embodiment of the present invention is the aqueous pharmaceutical suspension, wherein the pH is from about 5.00 to about 8.00; or more particularly from 5.80 to about 7.00.

[0046] Another specific embodiment of the present invention is the aqueous pharmaceutical suspension, wherein at least about 90% of fexofenadine zwitterionic dihydrate form I has a particle size of less than about 50 μm; or more particularly less than 40 μm .

[0047] Another specific embodiment of the present invention is ...

Embodiment 1

[0129] Add propylparaben (3.06kg) and butylparaben (1.53kg) into a stainless steel container of appropriate size containing about 198.2kg propylene glycol, and use a high-shear mixer (ie Rotosolver TM ) To dissolve it. Slowly add xanthan gum to the mixture and disperse evenly. The circulation loop was connected, and the dispersion was transferred to a jacketed main mixing tank containing about 5,488 kg of pure water preheated to 35-45°C and mixed. Continue to mix the materials until the end of the process. Maintain the temperature until the xylitol addition step. Rinse the container with the remaining propylene glycol (27kg) and part of pure water (about 50.3kg), and transfer the rinse liquid to the main mixing tank. Disodium edetate (1.351 kg) was added to the jacketed container and allowed to dissolve. A part of disodium hydrogen phosphate heptahydrate (67.57 kg) and sodium dihydrogen phosphate monohydrate (41.45 kg) were added to the jacketed container and dissolved. Sucrose (...

Embodiment 2

[0131] According to the general method of Example 1, a suspension containing about 30 mg of fexofenadine zwitterionic dihydrate form I (converted from fexofenadine hydrochloride anhydrous form I) per 5 mL suspension was prepared. A suspension with the composition shown in Table 1. In this formulation, the level of sucrose was reduced from about 20% weight / volume (g / 100 mL) to about 10% weight / volume (g / 100 mL).

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Abstract

The present invention is directed to an aqueous pharmaceutical suspension of fexofenadine zwitterionic dihydrate Form I.

Description

Invention field [0001] The present invention relates to an aqueous suspension formulation of fexofenadine zwitterionic dihydrate form I. Background of the invention [0002] As disclosed in US Patent 4,254,129 and US Patent Publication 2002-0193603 A1, fexofenadine and its pharmaceutically acceptable salts can be used as antihistamines. Fexofenadine hydrochloride is commercially available in various solid dosage forms, including immediate release capsules, immediate release tablets, and sustained release tablets. However, there is no disclosure about fexofenadine or fexofenadine in the form of a zwitterionic dihydrate crystalline form of an aqueous suspension. There is neither one that is particularly suitable for easy administration to children like the suspension formulation of the present invention, nor is particularly suitable for administration to adults who have difficulty swallowing capsules and tablets like the suspension formulation of the present invention. Disclosure o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/445
CPCA61K9/0095A61K31/445A61K9/10A61P37/08
Inventor P·阿格拉瓦拉K·赫然R·哈里布哈克提M·梅尔梅里C·J·波尔切洛G·L·西尔维V·德兰
Owner SANOFI AVENTIS US LLC
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