Claims for Patent: 10,722,456

Summary for Patent: 10,722,456

Title:	Oral composition of celecoxib for treatment of pain
Abstract:	The present invention relates to a stable oral liquid pharmaceutical composition of celecoxib or pharmaceutically acceptable salts thereof. The celecoxib present in the compositions as described herein do not show any precipitation when subjected in Fasted-State Simulated Gastric Fluid (FaSSGF) at pH 2.0, temperature of 37.degree. C..+-.0.5.degree. C. and under stirring at a speed of 50 rpm at least for 60 minutes. It also relates to the process of preparing and method of using said composition of celecoxib.
Inventor(s):	Munjal; Sagar (Skillman, NJ), Baheti; Ankit (Madhya Pradesh, IN), Padhi; Bijay Kumar (Ganjam, IN), Vakada; Supritha (Telangana, IN), Raghuvanshi; Rajeev Singh (Gurgaon, IN)
Assignee:	DR. REDDY'S LABORATORIES LTD (Hyderabad, Telangana, IN)
Application Number:	15/607,216
Patent Claims:	1. A method for providing pain freedom in a human subject suffering from pain, said method comprising administering to the subject a stable oral liquid pharmaceutical composition comprising: i. celecoxib in an amount from about 120 mg to about 240 mg; ii. at least one medium chain glyceride in an amount from about 5% to about 75% by weight, based on the total weight of the composition; and iii. at least one pharmaceutically acceptable excipient; wherein the at least one medium chain glyceride comprises glyceryl monocaprylate, glyceryl tricaprylate/tricaprate, or a combination thereof. 2. The method of claim 1, wherein said pain freedom is maintained for at least about 2 hours to about 24 hours. 3. The method of claim 1, wherein said composition is in the form of a solution, suspension, emulsion or liquid mixture. 4. The method of claim 1, wherein said composition has a pH of from about 3 to about 7. 5. The method of claim 1, where in the composition comprises a solubilizer and celecoxib in a weight ratio from about 4.0:1.0 to about 20:1.0. 6. The method of claim 1, whereby the subject is provided with pain freedom at 2 hours following administration. 7. The method of claim 1, wherein said composition further comprises at least one solubilizer in an amount from about 35% w/w to about 45% w/w, based on the total weight of the composition. 8. The method of claim 1, further comprising a solubilizer and a polar solvent, wherein said solubilizer and polar solvent are present in a weight ratio of 0.60:1 to 1.8:1. 9. The method of claim 1, wherein said composition further comprises at least one polar solvent in an amount from about 25% w/w to about 42% w/w, based on the total weight of the composition. 10. A method for providing partial pain relief in a human subject suffering from pain, said method comprising administering to the subject a stable oral liquid pharmaceutical composition comprising: i. in an amount from about 120 mg to about 240 mg; ii. at least one medium chain glyceride in an amount from about 5% to about 75% by weight, based on the total weight of the composition; and iii. at least one pharmaceutically acceptable excipient; wherein the at least one medium chain glyceride comprises glyceryl monocaprylate, glyceryl tricaprylate/tricaprate, or a combination thereof. 11. The method of claim 10, wherein said partial pain relief is at least .gtoreq.1 level lower pain intensity reported by the human subject suffering from pain, than the predose rating on a numeric rating scale for pain with a range of 0 (no pain) to 3 (severe). 12. The method of claim 10, wherein said partial pain relief is maintained for at least about 4 hours. 13. The method of claim 10, wherein said composition is in the form of a solution, suspension, emulsion or liquid mixture. 14. The method of claim 10, wherein said composition has a pH of from about 3 to about 7. 15. The method of claim 10, where in the composition comprises a solubilizer and celecoxib in a weight ratio from about 4.0:1.0 to about 20:1.0. 16. The method of claim 10, wherein said composition further comprises at least one solubilizer in an amount from about 35% w/w to about 45% w/w, based on the total weight of the composition. 17. The method of claim 10, further comprising a solubilizer and a polar solvent, wherein said solubilizer and polar solvent are present in a weight ratio of 0.60:1 to 1.8:1. 18. The method of claim 10, wherein said composition further comprises at least one polar solvent in an amount from about 25% w/w to about 42% w/w, based on the total weight of the composition. 19. A method for reducing nausea, photophobia and/or phonophobia in a human subject suffering from migraine, said method comprising administering to the subject a stable oral liquid pharmaceutical composition comprising: i. celecoxib in an amount from about 120 mg to about 240 mg; ii. at least one medium chain glyceride in an amount from about 5% to about 75% by weight, based on the total weight of the composition; and iii. at least one pharmaceutically acceptable excipient; wherein the at least one medium chain glyceride comprises glyceryl monocaprylate, glyceryl tricaprylate/tricaprate, or a combination thereof; whereby the subject is provided with a reduction in nausea, photophobia and/or phonophobia. 20. The method of claim 19, wherein said composition is in the form of a solution, suspension, emulsion or liquid mixture. 21. The method of claim 19, wherein said composition has a pH of from about 3 to about 7. 22. The method of claim 19, where in the composition comprises a solubilizer and celecoxib in a weight ratio from about 4.0:1.0 to about 20:1.0. 23. The method of claim 19, wherein said composition further comprises at least one solubilizer in an amount from about 35% w/w to about 45% w/w, based on the total weight of the composition. 24. The method of claim 19, further comprising a solubilizer and a polar solvent, wherein said solubilizer and polar solvent are present in a weight ratio of 0.60:1 to 1.8:1. 25. The method of claim 19, wherein said composition further comprises at least one polar solvent in an amount from about 25% w/w to about 42% w/w, based on the total weight of the composition.