Highly concentrated stable meloxicam solutions for needleless injection

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.

1 . 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, characterised in that the content of dissolved meloxicam salt is from 35 to 100 mg/ml. 
     
     
         2 . Aqueous solution according to  claim 1 , characterised in that the meloxicam salt is the sodium or meglumine salt. 
     
     
         3 . Aqueous solution according to  claim 2 , characterised in that it contains meglumine and meloxicam in a molar ratio of between 9:8 and 12:8. 
     
     
         4 . Aqueous solution according to  claim 3 , characterised in that it contains meglumine* and meloxicam in a molar ratio of 10:8. 
     
     
         5 . Aqueous solution according to one of  claims 1  to  4 , characterised in that it contains one or more excipients selected from among the buffers and/or preservatives. 
     
     
         6 . Aqueous solution according to one of  claims 1  to  5 , characterised in that it contains one or more excipients selected from among the solubilisers. 
     
     
         7 . Aqueous solution according to one of  claims 1  to  6 , characterised in that it contains disodium EDTA. 
     
     
         8 . Aqueous solution according to one of  claims 1  to  7 , characterised in that it has a shelf-life after opening of 28 days or more at ambient temperature. 
     
     
         9 . Aqueous solution according to one of  claims 1  to  8 , characterised in that it has a long term shelf-life of 24 months or more at ambient temperature in its original packaging. 
     
     
         10 . Aqueous solution according to one of  claims 1  to  9 , characterised in that it has a pH of between 8.0 and 10. 
     
     
         11 . Aqueous solution according to one of  claims 1  to  10 , containing meloxicam, meglumine, a polyethyleneglycol, a polyoxyethylene-polyoxypropylene copolymer, ethanol, glycine and optionally sodium hydroxide or hydrochloric acid, characterised in that it contains disodium EDTA. 
     
     
         12 . Aqueous solution according to one of  claims 1  to  10 , essentially consisting of meloxicam, meglumine, a polyethyleneglycol, a polyoxyethylene-polyoxypropylene copolymer, ethanol, glycine, water suitable for injection and optionally sodium hydroxide or hydrochloric acid, characterised in that it contains disodium EDTA. 
     
     
         13 . Use of a solution of meloxicam according to one of  claims 1  to  12  for preparing a pharmaceutical composition for treating pain, inflammation, fever and respiratory complaints in mammals. 
     
     
         14 . Use of a solution according to  claim 13 , which corresponds to a dosage range of from 0.2 to 1.0 mg of active substance/kg of bodyweight. 
     
     
         15 . Use of a solution according to one of  claims 13  or  14  for preparing a pharmaceutical composition for needleless injection. 
     
     
         16 . Sterile cartridge containing a solution according to one of  claims 1  to  12 , which can be used in a needleless injection system.