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Veterinary aqueous injectable suspensions containing florfenicol

A florfenicol and suspension technology, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, organic active ingredients, etc. question

Inactive Publication Date: 2010-06-23
CALLUNA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although the formulation reportedly exhibited acceptable tissue tolerance at the injection site, it was considered painful by licensed veterinarians to inject the formulation
[0007] Although the injectable formulation described in European patent 0546018B1 may improve the previous injectable solution (such as the preparation dissolved in pure N-methyl-2-pyrrolidone), if it is combined with other physiologically acceptable aqueous solutions and The formulation is also very irritating and painful compared to a suspension (containing a lower concentration of a physiologically acceptable solvent, having a physiologically acceptable pH and having a significantly lower osmotic pressure at the injection site)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Micronized Florfenicol 300mg

[0060] Sodium citrate 50.0mg

[0061] Potassium dihydrogen phosphate 1.5mg

[0062] Glucose monohydrate 80.0mg

[0063] Low viscosity sodium carboxymethylcellulose (CMC) 2.0mg

[0064] Polyvinylpyrrolidone K 12 3.5mg

[0065] Lecithin 3.0mg

[0066] Sodium formaldehyde sulfoxylate 2.5mg

[0067] Sodium metabisulfite 0.1mg

[0068] Sodium edetate 0.1mg

[0069] Methylparaben 1.0mg

[0070] Propylparaben 0.5mg

[0071] Add appropriate amount (q.s.ad) of water for injection 1ml

Embodiment 2

[0073] Micronized Florfenicol 250mg

[0074] Sodium citrate 50.0mg

[0075] Sorbitol (70%) 250.0mg

[0076] Medium viscosity sodium carboxymethylcellulose (CMC) 0.8mg

[0077] Polyvinylpyrrolidone K 15 3.5mg

[0078] Polysorbate 80 1.0mg

[0079] Sorbitan monooleate 1.0mg

[0080] Sodium formaldehyde sulfoxylate 2.5mg

[0081] Sodium phosphite 10.0mg

[0082] Sodium edetate 0.1mg

[0083] Benzyl Alcohol 9.0mg

[0084] Add appropriate amount of water for injection 1ml

Embodiment 3

[0086] Micronized Florfenicol 400.0mg

[0087] Sodium citrate 80.0mg

[0088] Potassium dihydrogen phosphate 10.0mg

[0089] Sodium Gluconate 150.0mg

[0090] Low viscosity sodium carboxymethylcellulose (CMC) 1.5mg

[0091] Polyvinylpyrrolidone K 12 3.5mg

[0092] Lecithin 3.0mg

[0093] Sodium formaldehyde sulfoxylate 2.5mg

[0094] Sodium metabisulfite 0.1mg

[0095] Sodium edetate 0.1mg

[0096] Methylparaben 1.0mg

[0097] Propylparaben 0.5mg

[0098] Add appropriate amount of water for injection 1ml

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Abstract

This invention relates to pharmaceutical compositions for veterinary use in form of aqueous injectable suspensions comprising Florfenicol or Florfenicol in form of a substantially water-insoluble complex, co-crystal or salt, sterile and micronised, in a concentration up to 500 mg / ml. The suspensions enable parenteral antimicrobial therapies in animals, with limited numbers of injections and showing good general- and local tolerances. They also possess a limited sedimentation on standing as well as after shipping, are easily resuspendable and have good syringiblity.

Description

technical field [0001] The present invention relates to a pharmaceutical composition for veterinary use containing a high concentration of florfenicol as a pharmaceutically active ingredient, more particularly said composition is an aqueous injectable suspension. Background technique [0002] Florfenicol [D-(threo)-1-p-methylsulfonylphenyl-2-dichloroacetamido-3-fluoro-1-propanol] is an antibacterial agent known to be commonly used for veterinary purposes. Florfenicol is a broad-spectrum antibiotic active to a variety of pathogenic veterinary bacteria (NEU et al., Antimicrob. 19, 2, 294-297). [0003] Injectable formulations containing florfenicol have been described in several patents. [0004] European Patent 0014437B1 not only discloses the synthesis of florfenicol, but also discloses examples of different formulations, including oral suspensions, injectable solutions in water / dimethylacetamide mixtures and sterile powders for immediate reconstitution. [0005] European...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/165A61K47/32A61K47/38A61P31/04A61K47/12A61K47/26
CPCA61K9/0019A61K47/26A61K47/38A61K31/165A61K47/12A61P31/04
Inventor 埃尔温·恩布莱驰简·恩布莱驰
Owner CALLUNA PHARMA