Formulation of indomethacin
First Claim
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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.
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Abstract
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.
69 Citations
28 Claims
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 17, 19, 21, 22, 23, 24)
- C. in 900 ml of 100 mM citric acid buffer (pH 5.5±
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9. A method of treating pain comprising administering a solid unit dose of a pharmaceutical composition containing 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 66%, 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. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 18, 20, 25, 26, 27, 28)
- C. in 900 ml of 100 mM citric acid buffer (pH 5.5±
Specification