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Claims for Patent: 9,017,721

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Claims for Patent: 9,017,721

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:14/277,287
Patent Claims: 1. 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 unit dose 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 unit dose 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.

4. The unit dose 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 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. The unit dose of claim 1 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.

7. The unit dose of claim 1 wherein the unit dose is a tablet or a capsule.

8. 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.

9. The unit dose of claim 8 wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 900 nm and greater than 25 nm.

10. The unit dose of claim 8, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 95%, by weight, is released by 60 minutes.

11. The unit dose of claim 8, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 95%, by weight, is released by 45 minutes.

12. The unit dose of claim 8, wherein the unit dose has a dissolution rate of diclofenac acid such that at least 95%, by weight, is released by 30 minutes.

13. The unit dose of claim 8 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.

14. The unit dose of claim 8 wherein the unit dose is a tablet or a capsule.

15. The unit dose 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.

16. The unit dose of claim 1 wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 700 nm and greater than 25 nm.

17. The unit dose of claim 8 wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 800 nm and greater than 25 nm.

18. The unit dose of claim 8 wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 700 nm and greater than 25 nm.

19. The unit dose of claim 1 wherein a single dose provides perceptible pain relief to a patient suffering from acute pain.

20. The unit dose of claim 4 wherein a single dose provides perceptible pain relief to a patient suffering from acute pain.

21. The unit dose of claim 8 wherein a single dose provides perceptible pain relief to a patient suffering from acute pain.

22. The unit dose of claim 11 wherein a single dose provides perceptible pain relief to a patient suffering from acute pain.

23. The unit dose 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.

24. The unit dose of claim 8 wherein the diclofenac acid has a median particle size, on a volume average basis, of less than 800 nm and greater than 25 nm.
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