Highly concentrated stable meloxicam solutions

a meloxicam solution, high-concentration technology, applied in the direction of pharmaceutical active ingredients, dispersed delivery, organic active ingredients, etc., can solve the problems of inability to treat large farm animals with an injectable meloxicam solution, inability to produce stable, clear, aqueous solutions, and cloudiness of solutions

Inactive Publication Date: 2013-07-11
BOEHRINGER LNGELHEIM VETMEDICA GMBH
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  • Summary
  • Abstract
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  • Claims
  • Application Information

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Problems solved by technology

However, until now it has only been possible to produce stable, clear, aqueous solutions with a low concentration of meloxicam.
Formulation tests with the same or a similar recipe led to cloudiness of the solution if the meloxicam concentrations were higher, e.g., 2%.
Thus, it has not hitherto been possible to treat large farm animals with an injectable meloxicam solution as the low concentration of active substance in the injectable solution did not allow an acceptable, well-tolerated injection volume due to the great weight of the animals.
Furthermore, parenteral administration requires that the solution be free from particles; if there are particles in a parenteral drug, there is a risk of vascular damage or embolism.
Moreover, organic solvents, solubilizers, and water-soluble substances can only be used in certain concentrations to achieve acceptable drug tolerance.

Method used

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Examples

Experimental program
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Effect test

examples

[0045]

Example 1: 2% Meloxicam SolutionComponentAmount (g / L)Meloxicam20.0Meglumine14.0Macrogol 3001150.0Poloxamer 188250.0Ethanol150.0Glycine5.0EDTA—Na1.01M HClq.s. ad pH 8.81M NaOHq.s. ad pH 8.8Water for injectionsad 1000 mLLegend:1obtainable from Brenntag, Plochingen, Germany; and2obtainable from C.H. Erbsloeh, Krefeld, Germany

[0046]Method:

[0047]20 g of meloxicam are dissolved in 500 mL of an aqueous meglumine solution (14 g / 500 mL) at 90° C. The other excipients are added one after another to the solution according to the recipe given above. A pH of 8.8 is then achieved using 1M hydrochloric acid and 1M sodium hydroxide solution. Water is added to the solution until a volume of 1 liter is obtained.

Example 2: 2% Meloxicam SolutionComponentAmount (g / L)Meloxicam20.0Meglumine12.5PEG 400100.0Poloxamer50.0Ethanol150.0Glycine5.0EDTA—Na1.01M HClq.s. ad pH 8.81M NaOHq.s. ad pH 8.8Water for injectionsad 1000 mL

[0048]Method:

[0049]20 g of meloxicam are dissolved in 500 mL of an aqueous meglum...

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Abstract

Aqueous cyclodextrin-free solution of meloxicam for administration by oral or parenteral route, 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 more than 10 mg / mL. The formulation according to the invention has a shelf-life of up to 24 months or more.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to pending U.S. Nonprovisional application Ser. No. 11 / 290,933, filed 30 Nov. 2005 and entitled “Highly Concentrated Stable Meloxicam Solutions,” which claims priority to abandoned U.S. Nonprovisional application Ser. No. 09 / 860,737, filed 18 May 2001 and entitled “Highly Concentrated Stable Meloxicam Solutions,” which claims priority to U.S. Provisional Application No. 60 / 216,004, filed 3 Jul. 2000 and entitled “Highly Concentrated Stable Meloxicam Solutions,” and which claims priority to German Application No. 100 30 345.5, filed 20 Jun. 2000. The disclosure of each aforementioned application is incorporated herein by reference in its entirety.FIELD OF THE INVENTION[0002]The present invention relates to highly concentrated stable meloxicam solutions for oral and parenteral administration, particularly for treating respiratory diseases in large farm animals.BACKGROUND OF THE INVENTION[0003]Meloxicam (4-hy...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K47/18A61K31/5415A61K9/00A61K47/10A61K47/26
CPCA61K9/0019A61K9/0095A61K47/26A61K47/10A61K47/183A61K31/5415A61K45/06
Inventor HENKE, STEFANKRUSS, BERNDHASSEL, BERNHARDKROFF, HANS-JUERGENFOLGER, MARTIN A.DANECK, KLAUSPROX, AXEL
Owner BOEHRINGER LNGELHEIM VETMEDICA GMBH
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