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Claims for Patent: 8,679,544

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Claims for Patent: 8,679,544

Title:Formulation of diclofenac
Abstract: The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac 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 Pty Ltd. (Philadelphia, PA)
Application Number:13/750,869
Patent Claims: 1. A unit dose of a pharmaceutical composition containing 18 mg of diclofenac acid and comprising lactose monohydrate and sodium lauryl sulfate wherein the particles of diclofenac acid have a median particle size on a volume average basis of less than 500 nm and greater than 25 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 0.05% sodium lauryl sulfate in citric acid solution buffered to pH 5.75 has a dissolution rate of diclofenac acid such that at least 91%, by weight, is released by 45 minutes.

2. The unit dose of a pharmaceutical composition of claim 1, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 91%, by weight, is released by 30 minutes.

3. The unit dose of a pharmaceutical composition of claim 1, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 91%, by weight, is released by 15 minutes.

4. The unit dose of a pharmaceutical composition of claim 1, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 94%, by weight, is released by 45 minutes.

5. The unit dose of a pharmaceutical composition of claim 1, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 94%, by weight, is released by 30 minutes.

6. A unit dose of a pharmaceutical composition containing 35 mg of diclofenac acid and comprising lactose monohydrate and sodium lauryl sulfate wherein the particles of diclofenac acid have a median particle size on a volume average basis of less than 500 nm and greater than 25 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 0.05% sodium lauryl sulfate in citric acid solution buffered to pH 5.75 has a dissolution rate of diclofenac acid such that at least 82%, by weight, is released by 45 minutes.

7. The unit dose of a pharmaceutical composition of claim 6, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 82%, by weight, is released by 30 minutes.

8. The unit dose of a pharmaceutical composition of claim 6, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 82%, by weight, is released by 15 minutes.

9. The unit dose of a pharmaceutical composition of claim 6, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 95%, by weight, is released by 45 minutes.

10. The unit dose of a pharmaceutical composition of claim 6, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 95%, by weight, is released by 30 minutes.

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

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

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

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

15. The unit dose of claim 13 wherein the unit dose comprises microcrystalline cellulose, croscarmellose sodium, and sodium stearyl fumarate.

16. The unit dose of claim 14 wherein the unit dose comprises microcrystalline cellulose, croscarmellose sodium, and sodium stearyl fumarate.

17. The unit dose of claim 1 wherein the D(90), on a particle volume basis, is selected from: less than 2000 nm, less than 1900 nm, less than 1800, and less than 1700 nm.

18. The unit dose of claim 6 wherein the D(90), on a particle volume basis, is selected from: less than 2000 nm, less than 1900 nm, less than 1800, and less than 1700 nm.

19. The unit dose of claim 1 wherein the Tmax is selected from: less than 5 hours, less than 4.5 hours, less than 4 hours, less than 3.5 hours, less than 3 hours, less than 3.5 hours, less than 2 hours, less than 1.75 hours, less than 1.5 hours, less than 1.25 hours, less than 1 hour, less than 40 minutes, and less than 30 minutes.

20. The unit dose of claim 6 wherein the Tmax is selected from: less than 5 hours, less than 4.5 hours, less than 4 hours, less than 3.5 hours, less than 3 hours, less than 3.5 hours, less than 2 hours, less than 1.75 hours, less than 1.5 hours, less than 1.25 hours, less than 1 hour, less than 40 minutes, and less than 30 minutes.

21. The unit dose of claim 1 wherein the time to first perceptible pain relief in a human patient administered a single dose is shorter than the time to first perceptible pain relief in a human patient administered 400 mg of celecoxib.

22. The unit dose of claim 6 wherein the time to first perceptible pain relief in a human patient administered a single dose is shorter than the time to first perceptible pain relief in a human patient administered 400 mg of celecoxib.

23. The unit dose of claim 1 wherein the time to peak pain relief in a human patient administered a single dose is shorter than the time to peak pain relief in a human patient administered 400 mg of celecoxib.

24. The unit dose of claim 6 wherein the time to peak pain relief in a human patient administered a single dose is shorter than the time to peak pain relief in a human patient administered 400 mg of celecoxib.
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