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Details for Patent: 9,095,496

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Details for Patent: 9,095,496

Title:Formulation of indomethacin
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.
Inventor(s): Dodd; Aaron (Centennial Park, AU), Meiser; Felix (Claremont, AU), Norret; Marck (Darlington, AU), Russell; Adrian (Rivervale, AU), Bosch; H. William (Bryn Mawr, PA)
Assignee: iCeutica Pty Ltd. (Philadelphia, PA)
Filing Date:Jan 06, 2014
Application Number:14/148,635
Claims: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 in a mill containing a plurality of milling bodies 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 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.degree. 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.

2. The method of claim 1, wherein the solid unit dosage pharmaceutical composition has a dissolution rate of indomethacin such that at least 83%, by weight, is released by 60 minutes.

3. The method of claim 1, wherein the solid unit dosage pharmaceutical composition has a dissolution rate of indomethacin such that at least 83%, by weight, is released by 45 minutes.

4. The method of claim 1, wherein the solid unit dosage pharmaceutical composition has a dissolution rate of indomethacin such that at least 83%, by weight, is released by 30 minutes.

5. The method of claim 1, wherein the solid unit dosage pharmaceutical composition has a dissolution rate of indomethacin such that at least 83%, by weight, is released by 20 minutes.

6. The method of claim 1, wherein the particles of indomethacin have a median particle size, on a volume average basis, between 25 nm and 1000 nm.

7. The method of claim 1 wherein the particles of indomethacin have a median particle size, on a volume average basis, between 25 nm and 700 nm.

8. The method of claim 1, wherein the D90 of the particles of indomethacin, on a particle volume 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.

9. The method of any of claims 1-8 wherein the millable grinding compound is selected from lactose and mannitol and wherein the facilitating agent is sodium lauryl sulfate.

10. 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 in a mill containing a plurality of milling bodies 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.degree. 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.

11. The method of claim 10, wherein the solid unit dosage pharmaceutical composition has a dissolution rate of indomethacin such that at least 66%, by weight, is released by 60 minutes.

12. The method of claim 10, wherein the solid unit dosage pharmaceutical composition has a dissolution rate of indomethacin such that at least 66%, by weight, is released by 45 minutes.

13. The method of claim 10, wherein the solid unit dosage pharmaceutical composition has a dissolution rate of indomethacin such that at least 66%, by weight, is released by 30 minutes.

14. The method of claim 10, wherein the solid unit dosage pharmaceutical composition has a dissolution rate of indomethacin such that at least 66%, by weight, is released by 20 minutes.

15. The method of claim 10, wherein the particles of indomethacin have a median particle size, on a volume average basis, between 25 nm and 1000 nm.

16. The method of claim 10, wherein the particles of indomethacin have a median particle size, on a volume average basis, between 25 nm and 700 nm.

17. The method of claim 10, wherein the D90 of the particles of indomethacin, on a particle volume 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.

18. The method of any of claims 10-17 wherein the millable grinding compound is selected from lactose and mannitol and wherein the facilitating agent is sodium lauryl sulfate.
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