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Claims for Patent: 8,734,847

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Claims for Patent: 8,734,847

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 (Nedlands, AU), Meiser; Felix (Claremont, AU), Norret; Marck (Darlington, AU), Russell; Adrian (Rivervale, AU), Bosch; H William (Bryn Mawr, PA)
Assignee: Iceutica Py Ltd. (Philadelphia, PA)
Application Number:13/776,536
Patent Claims: 1. A unit dose of a pharmaceutical composition containing 20 mg of indomethacin and comprising lactose monohydrate and sodium lauryl sulfate wherein the indomethacin has a median particle size on a volume average basis of less than 500 nm and wherein the unit dose 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 solution buffered to pH 5.5 has a dissolution rate of indomethacin such that at least 83%, by weight, is released by 30 minutes.

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

3. The unit dose of a pharmaceutical composition of claim 1, wherein the unit dose has a dissolution rate of indomethacin such that at least 83%, by weight, is released by 10 minutes.

4. The unit dose of a pharmaceutical composition of claim 1, wherein the unit dose has a dissolution rate of indomethacin such that at least 99%, by weight, is released by 20 minutes.

5. The unit dose of a pharmaceutical composition of claim 1, wherein the unit dose has a dissolution rate of indomethacin such that at least 99%, by weight, is released by 30 minutes.

6. A unit dose of a pharmaceutical composition containing 40 mg of indomethacin and comprising lactose monohydrate and sodium lauryl sulfate wherein the indomethacin has a median particle size on a volume average basis of less than 500 nm, wherein the unit dose 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 solution buffered to pH 5.5 has a dissolution rate of indomethacin such that at least 66%, by weight, is released by 30 minutes.

7. The unit dose of a pharmaceutical composition of claim 6, wherein the unit dose has a dissolution rate of indomethacin such that at least 66%, by weight, is released by 20 minutes.

8. The unit dose of a pharmaceutical composition of claim 6, wherein the unit dose has a dissolution rate of indomethacin such that at least 66%, by weight, is released by 10 minutes.

9. The unit dose of a pharmaceutical composition of claim 6, wherein the unit dose has a dissolution rate of indomethacin such that at least 93%, by weight, is released by 20 minutes.

10. The unit dose of a pharmaceutical composition of claim 6, wherein the unit dose has a dissolution rate of indomethacin such that at least 93%, by weight, is released by 30 minutes.

11. The unit dose of claim 1 wherein the median size of the indomethacin on a particle volume basis is less than 400 nm.

12. The unit dose of claim 6 wherein the median size of the indomethacin on a particle volume basis is less than 400 nm.

13. The unit dose of claim 1 wherein the unit dose is a hard gelatin capsule.

14. The unit dose of claim 6 wherein the unit dose is a hard gelatin capsule.

15. The unit dose of claim 1 wherein the unit dose further comprises: a binder, a lubricant, and a disintegrant.

16. The unit dose of claim 6 wherein the unit dose further comprises: a binder, a lubricant, and a disintegrant.

17. The unit dose of claim 15 wherein the unit dose comprises microcrystalline cellulose, croscarmellose sodium, and sodium stearyl fumarate.

18. The unit dose of claim 16 wherein the unit dose comprises microcrystalline cellulose, croscarmellose sodium, and sodium stearyl fumarate.

19. The unit dose of claim 1 wherein the D(90), on a particle volume basis, is selected from: less than 5000 nm and less than 3000 nm.

20. The unit dose of claim 6 wherein the D(90), on a particle volume basis, is selected from: less than 5000 nm and less than 3000 nm.

21. The unit dose of claim 1 wherein the mean Tmax in fasted subjects is 1.1 hrs or less.

22. The unit dose of claim 6 wherein the mean Tmax in fasted subjects is 1.25 hrs or less.
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