| 摘要 |
A method is disclosed for improving the dissolution profile of meloxicam, comprising the steps of: dry milling solid meloxicam and a millable grinding matrix in a mill, for a time period sufficient to produce particles of meloxicam, dispersed in an at least partially milled 5 grinding matrix, wherein the median particle size of the meloxicam, determined on a particle volume basis, is equal to or less than 5000nm, and wherein when tested in vitro by USP Apparatus II (Paddles) method of U.S. Pharmacopoeia at 50 rpm at 37°C±0.5°C in 500 ml of 10 mM phosphate buffer (pH 10 6.1±0.05) and 0.1% w/w sodium lauryl sulfate, the particles of meloxicam produced by said method have a dissolution rate such that at least 75%, by weight, is dissolved by 60 minutes, when measured under sink conditions. |
