Formulation of indomethacin
First Claim
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1. A method for producing a solid unit dosage pharmaceutical composition comprising indomethacin, comprising:
- dry milling a composition comprising indomethacin, a millable grinding compound and a facilitating agent for a time period sufficient to produce a composition comprising particles of indomethacin having a median particle size, on a particle volume basis, between 2,000 nm and 25 nm; and
processing the composition comprising particles of indomethacin into a solid unit dosage pharmaceutical composition containing 20 mg of indomethacin, wherein the solid unit dosage pharmaceutical composition, 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.
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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.
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Citations
19 Claims
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1. A method for producing a solid unit dosage pharmaceutical composition comprising indomethacin, comprising:
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dry milling a composition comprising indomethacin, a millable grinding compound and a facilitating agent for a time period sufficient to produce a composition comprising particles of indomethacin having a median particle size, on a particle volume basis, between 2,000 nm and 25 nm; and processing the composition comprising particles of indomethacin into a solid unit dosage pharmaceutical composition containing 20 mg of indomethacin, wherein the solid unit dosage pharmaceutical composition, 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 19)
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10. A method for producing a solid unit dosage pharmaceutical composition comprising indomethacin, comprising:
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dry milling a composition comprising indomethacin, a millable grinding compound and a facilitating for a time period sufficient to produce a composition comprising particles of indomethacin having a median particle size, on a particle volume basis, between 3,000 nm and 25 nm; and processing the composition comprising particles of indomethacin into a solid unit dosage pharmaceutical composition containing 40 mg of indomethacin, wherein the solid unit dosage pharmaceutical composition, 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. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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Specification