Highly concentrated stable meloxicam solutions for needleless injection

a meloxicam and solution technology, applied in the direction of respiratory disorders, organic active ingredients, pharmaceutical non-active ingredients, etc., can solve the problems of unfavorable large-scale farm animals with meloxicam solutions, inability to produce stable, clear, aqueous solutions, and cloudiness of solutions

Inactive Publication Date: 2008-06-05
FOLGER MARTIN ANDREAS +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, up till now it has only been possible to produce stable, clear, aqueous solutions with a low concentration of meloxicam.
Attempts to produce formulations with the same or a similar recipe led to cloudiness of the solution, e.g. if the meloxicam concentrations were higher, e.g. 2%.
It has not hitherto been possible to treat large farm animals with a meloxicam solution that could be injected without a needle.
The low concentration of active substance in the injectable solution did not allow an acceptable, well tolerated injection volume.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example

[0036]4% meloxicam solution

Ingredients:

[0037]

g / 100 mlMeloxicam4.0Meglumine2.8Macrogol 300*115.0Poloxamer 188*25.0Ethanol15.6Glycine0.5EDTA-Na0.11M HClq.s. ad pH 8.81M NaOHq.s. ad pH 8.8Water for injectionsad 100 ml*1obtainable from Brenntag, Plochingen, Germany*2obtainable from C. H. Erbsloeh, Krefeld, Germany

[0038]For example, dogs may be treated by needle-free injection with a 4% meloxicam solution according to the invention in a metered volume of 50 μl per spray jet in a precise dosage related to body weight. A dog weighing 10 kg can be treated with a dose of 0.2 mg of meloxicam per kg of body weight with precisely one spray jet. Therapeutic accuracy is ensured in this case in steps of 10 kg.

Method of Preparation:

[0039]4 g of meloxicam are dissolved in 50 ml of an aqueous meglumine solution (1.4 g / 50 ml) at 90° C. The other excipients are added one after another to the solution according to the recipe given above. The pH is then adjusted to 8.8 using 1 M hydrochloric acid and 1 M...

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Abstract

Aqueous cyclodextrin-free solution of meloxicam suitable for administration by needleless injection, containing a pharmacologically acceptable meloxicam salt of an organic or inorganic base and one or more suitable excipients, the content of dissolved meloxicam salt being from 35 to 100 mg / ml. The formulation according to the invention has a shelf-life of up to 24 months or more.

Description

[0001]The present invention relates to highly concentrated stable meloxicam solutions for intracutaneous or subcutaneous needleless injection for treating respiratory diseases and inflammation in mammals.BACKGROUND OF THE INVENTION[0002]Meloxicam (4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide) is an active substance which belongs to the group of NSAIDs (non-steroidal-anti-inflammatory drugs). Meloxicam and the sodium and meglumine salt thereof (N-methyl-D-glucamine salt) are described in EP-A-0 002 482. EP-A-0 002 482 shows, inter alia, the example of a 0.2% injectable solution of meloxicam consisting of the meglumine salt of the active substance, sodium chloride and water.[0003]EP-A-0 945 134 discloses the pH-dependent solubility characteristics of meloxicam and its salts, i.e. the sodium salt, the ammonium salt and the meglumine salt, in aqueous solution. According to this, meloxicam is an active substance which does not dissolve readil...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/5415A61P19/02A61K47/10A61K47/18A61K47/30A61P11/00A61P25/04A61P29/00
CPCA61K9/0021A61K47/183A61K47/10A61K31/5415A61P11/00A61P19/02A61P25/04A61P29/00
Inventor FOLGER, MARTIN ANDREASHENKE, STEFANHASSEL, BERNHARDZIERENBERG, BERND
Owner FOLGER MARTIN ANDREAS
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