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Claims for Patent: 9,180,095

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Claims for Patent: 9,180,095

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 (Centennial Park, AU), Meiser; Felix (Mount Claremont, AU), Norret; Marck (Darlington, AU), Russell; Adrian (Rivervale, AU), Bosch; H William (Bryn Mawr, PA)
Assignee: iCeutica Pty Ltd. (Philadelphia, PA)
Application Number:14/621,919
Patent Claims: 1. A method for treating pain comprising administering a solid oral unit dose of a pharmaceutical composition containing 18 mg of diclofenac acid to a subject, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 5000 nm and greater than 25 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 0.05% sodium lauryl sulfate in citric acid solution buffered to pH 5.75, has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 75 minutes.

2. The method of claim 1, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 3000 nm and greater than 25 nm.

3. The method of claim 2, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 60 minutes.

4. The method of claim 2, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 45 minutes.

5. The method of claim 2, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 30 minutes.

6. The method of claim 1, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 2000 nm and greater than 25 nm.

7. The method of claim 1, wherein the diclofenac acid have a median particle size, on a volume average basis, of less than 1900 nm and greater than 25 nm.

8. The method of claim 1, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 1700 nm and greater than 25 nm.

9. The method of claim 1, wherein the diclofenac acid have a median particle size, on a volume average basis, of less than 1500 nm and greater than 25 nm.

10. The method of claim 1, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 60 minutes.

11. The method of claim 1, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 45 minutes.

12. The method of claim 1, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 30 minutes.

13. The method of claim 1, wherein the pain is chronic pain or acute pain.

14. The method of claim 1, wherein the unit dose is administered at least once daily.

15. The method of claim 1, wherein a single unit dose provides perceptible pain relief.

16. A method for treating pain comprising administering a solid oral unit dose of a pharmaceutical composition containing 35 mg of diclofenac acid to a subject, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 5000 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 95%, by weight, is released by 75 minutes.

17. The method of claim 16, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 3000 nm and greater than 25 nm.

18. The method of claim 17, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 60 minutes.

19. The method of claim 17, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 45 minutes.

20. The method of claim 17, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 30 minutes.

21. The method of claim 16, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 2000 nm and greater than 25 nm.

22. The method of claim 16, wherein the diclofenac acid have a median particle size, on a volume average basis, of less than 1900 nm and greater than 25 nm.

23. The method of claim 16, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 1700 nm and greater than 25 nm.

24. The method of claim 16, wherein the diclofenac acid have a median particle size, on a volume average basis, of less than 1500 nm and greater than 25 nm.

25. The method of claim 16, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 60 minutes.

26. The method of claim 16, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 45 minutes.

27. The method of claim 16, wherein the unit dose has a dissolution rate of diclofenac acid such that 94%, by weight, is released by 30 minutes.

28. The method of claim 16, wherein the pain is chronic pain or acute pain.

29. The method of claim 16, wherein the unit dose is administered at least once daily.

30. The method of claim 16, wherein a single unit dose provides perceptible pain relief.
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