CPC A61K 9/1623 (2013.01) [A61K 9/0019 (2013.01); A61K 9/10 (2013.01); A61K 9/145 (2013.01); A61K 9/146 (2013.01); A61K 9/1617 (2013.01); A61K 9/1635 (2013.01); A61K 9/1688 (2013.01); A61K 31/5415 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/26 (2013.01); A61K 47/28 (2013.01); A61K 47/32 (2013.01)] | 40 Claims |
1. An injectable meloxicam composition substantially free of metals produced by a method comprising:
(a) preparing a dispersion of a liquid dispersion media, meloxicam and at least one surface stabilizer to form a meloxicam dispersion;
(b) milling the meloxicam dispersion in the presence of a grinding media, wherein the grinding media comprises polymeric or copolymeric resin beads and is substantially free of metals to form a meloxicam nanoparticle dispersion;
(c) adding a flake-like aggregation reducing agent to the meloxicam nanoparticle dispersion of step (b), wherein the flake-like aggregation reducing agent is selected from the group consisting of sucrose, mannitol and dextrose; and
(d) separating out the grinding media to thereby form the injectable meloxicam composition substantially free of metals;
wherein the meloxicam particles in the injectable meloxicam composition have an effective average particle size of less than about 300 nm, and no more than 6,000 meloxicam particles are greater than 10 μm and no more than 600 meloxicam particles are greater than 25 μm.
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