Formulation of indomethacin

摘要

The present invention relates to methods for producing particles of indomethacin using dry milling processes as well as compositions comprising indomethacin, medicaments produced using indomethacin in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of indomethacin administered by way of said medicaments.

主权项

1. A method of treating pain comprising administering a solid unit dose of a pharmaceutical composition containing 20 mg of indomethacin wherein the unit dose when tested in vitro by USP Apparatus I (Basket) method of U.S. Pharmacopoeia at 100 rpm at 37° C. in 900 ml of 100 mM citric acid buffer (pH 5.5±0.05) has a dissolution rate of indomethacin such that at least 83%, by weight, is released by 75 minutes and wherein the D90 of the indomethacin, on a particle volume basis, is selected from the group consisting of: less than 5000 nm, less than 4000 nm, 3000 nm, less than 2000 nm, less than 1900 nm, less than 1800 nm, and less than 1700 nm.