Claims for Patent: 9,017,721

Summary 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 Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,017,721
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.