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Generated: August 23, 2017

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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:14/167,652
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, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 1000 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 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 900 nm and greater than 25 nm.

3. The method of claim 1, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 800 nm and greater than 25 nm.

4. The method of claim 1, wherein the diclofenac acid have a median particle size, on a volume average basis, of less than 700 nm and greater than 25 nm.

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

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

7. The method 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.

8. The method 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.

9. The method of claim 2, wherein the D(90) of the diclofenac acid, on a particle volume basis, is selected from: less than 3000 nm, less than 2,000 nm, less than 1900 nm, less than 1800, and less than 1700 nm.

10. The method of claim 1 wherein the unit dose comprises a tablet or a capsule.

11. A method for treating pain comprising administering a solid oral unit dose of a pharmaceutical composition containing 35 mg of diclofenac acid, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 1000 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 95%, by weight, is released by 75 minutes.

12. The method of claim 11, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 900 nm and greater than 25 nm.

13. The method of claim 11, wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 800 nm and greater than 25 nm.

14. The method of claim 11, wherein the particles of diclofenac acid has a median particle size, on a volume average basis, of less than 700 nm and greater than 25 nm.

15. The method of claim 11, wherein the pain is chronic pain or acute pain.

16. The method of claim 11 wherein the unit dose has a dissolution rate of diclofenac acid such that at least 95%, by weight, is released by 60 minutes.

17. The method of claim 11, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 95%, by weight, is released by 45 minutes.

18. The method of claim 11, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 95%, by weight, is released by 30 minutes.

19. The method of claim 12, wherein the D(90) of the diclofenac acid, on a particle volume basis, is selected from: less than 3000 nm, less than 2000 nm, less than 1900 nm, less than 1800, and less than 1700 nm.

20. The method of claim 11 wherein the unit dose comprises a tablet or a capsule.

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

22. The method of claim 11 wherein the unit dose is administered at least once daily.

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

24. The method of claim 11 wherein a single unit dose provides perceptible pain relief.
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