Claims for Patent: 8,545,879

Summary for Patent: 8,545,879

Title:	Fast disintegrating compositions of meloxicam
Abstract:	The invention provides pharmaceutical compositions comprising a therapeutically effective amount of meloxicam, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical compositions are in the form of a fast disintegrating dosage form suitable for releasing meloxicam rapidly in the oral cavity. Also provided are processes for preparing a pharmaceutical composition of the invention. Further provided are methods of treating arthritis or pain in a subject in need thereof, the method comprising orally administering to the subject a therapeutically effective amount of a pharmaceutical composition according to the invention.
Inventor(s):	Burns; David Allen (Wilmington, NC), Neal; Gregory Edward (Swindon, GB)
Assignee:	Wilmington Pharmaceuticals, LLC (Wilmington, NC) R.P. Scherer Techonologies, Inc. (Somerset, NJ)
Application Number:	12/988,919
Patent Claims:	1. A pharmaceutical composition in a dosage form comprising a therapeutically effective amount of meloxicam, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is in the form of a fast disintegrating dosage form suitable for releasing meloxicam rapidly in the oral cavity and the particle size (D90) of meloxicam is in the range of about 5 to 40 microns. 2. The composition of claim 1, wherein meloxicam is released in less than about 30 seconds in the oral cavity. 3. The composition of claim 1, wherein meloxicam is released in less than about 10 seconds in the oral cavity. 4. The composition of claim 1, wherein meloxicam is released in less than about 3 seconds in the oral cavity. 5. The composition of claim 1, wherein meloxicam is selected from the group consisting of crystalline phase, an amorphous phase, a semi-crystalline phase, a semi-amorphous phase, and a combination thereof. 6. The composition of claim 1, wherein the amount of meloxicam is added in the range of about 5 mg to 20 mg. 7. The composition of claim 1, wherein the amount of meloxicam is in the range of about 20% to 45% by weight of the pharmaceutical composition. 8. The composition of claim 1, further comprising a matrix network. 9. The composition of claim 8, wherein the matrix network comprises at least one matrix former selected from gelatin, hydrolyzed dextran, and alginate. 10. The composition of claim 8, wherein the matrix former is a combination of gelatin and mannitol. 11. The composition of claim 10, wherein the amount of gelatin is in the range of about 15% to 40% by weight of the pharmaceutical composition. 12. The composition of claim 10, wherein the amount of gelatin is in the range of about 28% to 33% by weight of the pharmaceutical composition. 13. The composition of claim 10, wherein the amount of mannitol is in the range of about 10% to 30% by weight of the pharmaceutical composition. 14. The composition of claim 10, wherein the amount of mannitol is in the range of about 20% to 25% by weight of the pharmaceutical composition. 15. The composition of claim 8, wherein the matrix network is obtained by freeze drying a mixture of a therapeutically effective amount of meloxicam, a dispersing agent, and a matrix former to a solid state. 16. The composition of claim 8, further comprising at least one excipient selected from a pH modifier, sweetener and flavor. 17. The composition of claim 16, wherein the pH modifier is citric acid. 18. The composition of claim 16, wherein the sweetener is aspartame. 19. The composition of claim 16, further comprising a taste masking agent and/or a coloring agent. 20. The composition of claim 1 packaged in a blister pocket. 21. The composition of claim 1, wherein the particle size (D90) of meloxicam is in the range of about 15 to 30 microns. 22. The composition of claim 1, wherein the particle size (D90) of meloxicam is in the range of about 18 to 21 microns. 23. The composition of claim 1, wherein the particle size (D90) of meloxicam is in the range of about 5 to 10 microns. 24. The composition of claim 1, wherein the particle size (D90) of meloxicam is about 6 microns.