Claims for Patent: 9,949,990

Summary for Patent: 9,949,990

Title:	Oral composition of celecoxib for treatment of pain
Abstract:	The present invention relates to a stable oral liquid pharmaceutical composition of celecoxib or its 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):	Baheti; Ankit (Indore, IN), Padhi; Bijay Kumar (Buguda, IN), Vakada; Supritha (Hyderabad, IN), Raghuvanshi; Rajeev Singh (Gurgaon, IN)
Assignee:	DR. REDDY'S LABORATORIES LTD. (Hyderabad, IN)
Application Number:	15/712,415
Patent Claims:	1. An oral pharmaceutical composition, comprising a reduced dose of celecoxib relative to conventional celecoxib in 400 mg oral capsules and at least one pharmaceutically acceptable excipient, wherein said composition a) releases no less than about 70% of the celecoxib at a period of 10 minutes; or b) releases no less than about 80% of the celecoxib at a period of 15 minutes, in 900 ml of 0.01N HCl with 0.5% sodium lauryl sulfate, when tested in a USP Type 2 apparatus with sinkers at 50 rpm and 37.degree. C. 2. The composition of claim 1, wherein said reduced dose of celecoxib is at least about 20% less than conventional celecoxib in 400 mg oral capsules. 3. The composition of claim 1, wherein said reduced dose of celecoxib is at least about 40% less than conventional celecoxib in 400 mg oral capsules. 4. The composition of claim 1, wherein said reduced dose of celecoxib is at least about 55% less than conventional celecoxib in 400 mg oral capsules. 5. The composition of claim 1, wherein said reduced dose of celecoxib is at least about 70% less than conventional celecoxib in 400 mg oral capsules. 6. The composition of claim 1, wherein said composition comprises of at least one solubilizer in an amount of from about 10% to about 70% by weight, based on the total weight of the composition. 7. The composition of claim 1, wherein said composition comprises of at least one medium chain glyceride in an amount of from about 5% to about 75% by weight, based on the total weight of the composition. 8. The composition of claim 1, wherein said composition comprises of at least one solvent in an amount of from about 20% to about 80% by weight, based on the total weight of the composition. 9. The composition of claim 1, wherein said composition is in the form of a solution, suspension, emulsion or liquid mixture. 10. The composition of claim 9, wherein said composition does not show any precipitation in Fasted-State Simulated Gastric Fluid (FaSSGF) at pH of 2.0, temperature of 37.degree. C..+-.0.5.degree. C. and under stirring at a speed of 50 rpm, when measured at 60 min. 11. A method for treating or ameliorating pain, comprising: administering the composition of claim 1 to a human subject. 12. The method of claim 11, wherein said pain is acute pain, migraine pain, cluster headache, neuropathic pain, post-operative pain, chronic lower back pain, herpes neuralgia pain, phantom limb pain, central pain, dental pain, neuropathic pain, opioid-resistant pain, visceral pain, surgical pain, bone injury pain, pain during labor and delivery, pain resulting from burns, sunburn pain, post-partum pain, angina pain, genitourinary tract-related pain, cystitis pain, arthritis pain, inflammation pain, osteoarthritis pain, juvenile rheumatoid arthritis pain, ankylosing spondylitis pain, or primary dysmenorrhea pain. 13. An oral pharmaceutical composition, comprising a reduced dose of celecoxib and at least one pharmaceutically acceptable excipient, wherein said reduced dose of celecoxib is about 240 mg and said composition a) releases no less than about 70% of the celecoxib at a period of 10 minutes; orb) releases no less than about 80% of the celecoxib at a period of 15 minutes, in 900 ml of 0.01N HCl with 0.5% sodium lauryl sulfate, when tested in a USP Type 2 apparatus with sinkers at 50 rpm and 37.degree. C. 14. The composition of claim 13, wherein said composition comprises of at least one solubilizer in an amount of from about 10% to about 70% by weight, based on the total weight of the composition. 15. The composition of claim 13, wherein said composition comprises of at least one medium chain glyceride in an amount of from about 5% to about 75% by weight, based on the total weight of the composition. 16. The composition of claim 13, wherein said composition comprises of at least one solvent in an amount of from about 20% to about 80% by weight, based on the total weight of the composition. 17. A method for treating or ameliorating pain, comprising: administering the composition of claim 13 to a human subject. 18. The composition of claim 13, which upon oral administration to a human subjects under fasting conditions, provides at least one of the following pharmacokinetic parameters: a. AUC.sub.(0-15 min) of at least about 10 ngh/mL; b. AUC.sub.(0-30 min) of at least about 80 ngh/mL; c. AUC.sub.(0-1 hr) of at least about 400 ngh/mL; d. AUC.sub.(0-2 hr) of at least about 1000 ngh/mL; e. AUC.sub.(0-t) of at least about 2000 ngh/mL; f. AUC.sub.(0-.infin.) of at least about 2000 ngh/mL; and g. T.sub.lag of not more than 8 minutes. 19. An oral pharmaceutical composition, comprising a reduced dose of celecoxib and at least one pharmaceutically acceptable excipient, wherein said reduced dose of celecoxib is about 180 mg and said composition a) releases no less than about 70% of the celecoxib at a period of 10 minutes; orb) releases no less than about 80% of the celecoxib at a period of 15 minutes, in 900 ml of 0.01N HCl with 0.5% sodium lauryl sulfate, when tested in a USP Type 2 apparatus with sinkers at 50 rpm and 37.degree. C. 20. The composition of claim 19, wherein said composition comprises of at least one solubilizer in an amount of from about 10% to about 70% by weight, based on the total weight of the composition. 21. The composition of claim 19, wherein said composition comprises of at least one medium chain glyceride in an amount of from about 5% to about 75% by weight, based on the total weight of the composition. 22. The composition of claim 19, wherein said composition comprises of at least one solvent in an amount of from about 20% to about 80% by weight, based on the total weight of the composition. 23. A method for treating or ameliorating pain, comprising: administering the composition of claim 19 to a human subject. 24. The composition of claim 19, which upon oral administration to a human subjects under fasting conditions, provides at least one of the following pharmacokinetic parameters: a. AUC.sub.(0-15 min) of at least about 10 ngh/mL; b. AUC.sub.(0-30 min) of at least about 80 ngh/mL; c. AUC.sub.(0-1 hr) of at least about 400 ngh/mL; d. AUC.sub.(0-2 hr) of at least about 1000 ngh/mL; e. AUC.sub.(0-t) of at least about 2000 ngh/mL; f. AUC.sub.(0-.infin.) of at least about 2000 ngh/mL; and g. T.sub.lag of not more than 8 minutes. 25. An oral pharmaceutical composition, comprising a reduced dose of celecoxib and at least one pharmaceutically acceptable excipient, wherein said reduced dose of celecoxib is about 120 mg and said composition a) releases no less than about 70% of the celecoxib at a period of 10 minutes; orb) releases no less than about 80% of the celecoxib at a period of 15 minutes, in 900 ml of 0.01N HCl with 0.5% sodium lauryl sulfate, when tested in a USP Type 2 apparatus with sinkers at 50 rpm and 37.degree. C. 26. The composition of claim 25, wherein said composition comprises of at least one solubilizer in an amount of from about 10% to about 70% by weight, based on the total weight of the composition. 27. The composition of claim 25, wherein said composition comprises of at least one medium chain glyceride in an amount of from about 5% to about 75% by weight, based on the total weight of the composition. 28. The composition of claim 25, wherein said composition comprises of at least one solvent in an amount of from about 20% to about 80% by weight, based on the total weight of the composition. 29. A method for treating or ameliorating pain, comprising: administering the composition of claim 25 to a human subject. 30. The composition of claim 25, which upon oral administration to a human subjects under fasting conditions, provides at least one of the following pharmacokinetic parameters: a. AUC.sub.(0-15 min) of at least about 10 ngh/mL; b. AUC.sub.(0-30 min) of at least about 80 ngh/mL; c. AUC.sub.(0-1 hr) of at least about 400 ngh/mL; d. AUC.sub.(0-2 hr) of at least about 1000 ngh/mL; e. AUC.sub.(0-t) of at least about 2000 ngh/mL; f. AUC.sub.(0-.infin.) of at least about 2000 ngh/mL; and g. T.sub.lag of not more than 8 minutes.