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Use of nifuratel to treat infections caused by clostridium species

A technology of nifuratel and uses, applied in the field of Clostridium difficile-associated diarrhea (CDAD), can solve problems such as unmet medical needs and the like

Inactive Publication Date: 2013-11-06
POLICHEM SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, there remains an unmet medical need in terms of efficacy and prevention of relapse

Method used

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  • Use of nifuratel to treat infections caused by clostridium species
  • Use of nifuratel to treat infections caused by clostridium species
  • Use of nifuratel to treat infections caused by clostridium species

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] In vitro studies were performed to investigate 3 C. difficile strains (1 reference strain ATCC17858 and 2 clinical isolates), 1 reference strain of Clostridium butyricum (ATCC17791) and 2 reference strains of C. ) susceptibility to nifuratel and compared with metronidazole and vancomycin. According to CLSI M11-A7, by broth dilution method, supplemented with hemin (Hemin) (5 μg / ml), vitamin K1 (1 μg / ml), lysed horse blood (5%) and oxidase (1 :25v / v) Determination of MIC (Minimum Inhibitory Concentration) in Brucella Broth. Nifuratel, vancomycin, and metronidazole (previously dissolved in dimethyl sulfoxide) were added to the medium. All compounds were tested at concentrations ranging from 0.125-128 μg / ml.

[0019] The in vitro activity of nifuratel against tested strains of C. difficile (MIC range: ≤0.125-0.25 μg / ml) was comparable to or superior to that of metronidazole (MIC range: 0.06-0.25 μg / ml) and vancomycin (MIC range: 0.25-0.5 μg / ml).

[0020] Fairly good act...

Embodiment 2

[0024] Oral tablets are manufactured using the following qualitative and quantitative formulations:

[0025]

[0026] The procedure consisted of preparing a (protected from light) binder solution with water and polyethylene glycol heated at 45°C under continuous stirring; then blending nifuratel and starch in a Glatt fluid bed basket until mass Granulation for homogeneity followed by spraying of binder solution followed by drying at an input air temperature of 60°C; followed by addition of talc and magnesium stearate. Compress into tablets in a rotary tablet press with suitable punches.

[0027] The resulting tablets had a yellow smooth surface.

Embodiment 3

[0029] A syrup with the following composition wt. / wt.% was prepared:

[0030]

[0031] preparation

[0032] This recipe is prepared (protected from light) as follows:

[0033] 1) Use deionized water and carboxymethyl cellulose (3.75% in water) to prepare the gel. Let the gel soak overnight.

[0034] 2) Prepare water, sucrose (50%) and sodium chloride (0.5%) solutions separately.

[0035] 3) A mixture of nifuratel (0.4%) and polysorbate 80 (1%) was prepared in water. The mixture is then stirred until homogeneous.

[0036] 4) Add deionized water, sorbitol and glycerin, solution 2) and sucrose in a closed container with a stirrer. The mixture was maintained under continuous stirring. Methylparaben, propylparaben, and silicon dioxide are then added. Heat with stirring at 100°C for 30 minutes. After cooling at 80°C, citric acid was added. After cooling at 40°C, gel 1) and formulation 3) were added with continuous stirring.

[0037] The resulting syrup is a homogeneous ...

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Abstract

The present invention is directed to the use of nifuratel, or a physiologically acceptable salt thereof, to treat infections caused by bacteria species of the genus Clostridium. The invention is further directed to the use of nifuratel to treat Clostridium difficile infection (CDI) and in particular Clostridium difficile associated diarrhoea (CDAD).

Description

[0001] The present invention relates to the use of nifuratel or a physiologically acceptable salt thereof in the treatment of infections caused by species of the genus Clostridium. The present invention further relates to the use of nifuratel in the treatment of Clostridium difficile infection (CDI) and in particular Clostridium difficile associated diarrhea (CDAD). Background of the invention [0002] Clostridium difficile is a Gram-positive, spore-forming, anaerobic bacterium that is the most common cause of antibiotic-associated diarrhea in hospitals and long-term care facilities. Clostridium difficile infection (CDI) can occur when patients are treated with broad-spectrum antibiotics (clindamycin is considered the most important cause), which alter the ecological balance of the normal gut flora, allowing C. difficile to proliferate and produce toxins. Symptoms of CDI can vary from mild diarrhea to fatal pseudomembranous colitis, fulminant colitis, toxic megacolon, and dea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/422A61P31/04
CPCA61K31/422A61K9/08A61K9/0095A61K47/26A61K9/2009A61K9/2886A61K9/2846A61K9/2059A61K45/06A61P1/00A61P1/12A61P31/00A61P31/04A61K2300/00C07D407/04
Inventor 安娜·布尔盖罗尼F·马兰德朱利亚娜·约伯
Owner POLICHEM SA
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