| abstract |
Disclosed are unit doses of indomethacin containing 20 mg or 40 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% for the 20 mg unit dose or 66% for the 40 mg unit dose, by weight, is released by 75 minutes. wherein the D90 of the indomethacin, on a volume average basis, is selected from the group consisting of: less than 3000 nm, less than 2000 nm, less than 1900 nm, less than 1800 nm, and less than 1700 nm |