Oral composition of celecoxib for treatment of pain
View Patent ↗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° C.±0.5° 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.
1. A method of rendering a human subject pain free within 2 hours, wherein said method comprising administering to said subject a stable oral pharmaceutical composition comprising a reduced dose of celecoxib relative to conventional celecoxib in 400 mg oral capsules, a solubilizer, a medium chain glyceride, a polar solvent, and a pharmaceutically-acceptable excipient g.
2. The method of claim 1 , wherein said composition comprises at least about 20% less celecoxib compared to conventional 400 mg oral celecoxib capsules.
3. The method of claim 1 , wherein said composition comprises at least about 40% less celecoxib compared to conventional 400 mg oral celecoxib capsules.
4. The method of claim 1 , wherein said composition comprises at least about 55% less celecoxib compared to Conventional 400 mg oral celecoxib capsules.
5. The method of claim 1 , wherein said composition comprises at least about 70% less celecoxib compared to conventional 400 mg oral celecoxib capsules.
6. The method of claim 2 , wherein said reduced dose of celecoxib is about 320 mg.
7. The method of claim 3 , wherein said reduced dose of celecoxib is about 240 mg.
8. The method of claim 4 , wherein said reduced dose of celecoxib is about 180 mg.
9. The method of claim 5 , wherein said reduced dose of celecoxib is about 120 mg.
10. The method of claim 1 , 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.
11. The method of claim 1 , wherein said composition is in the form of a solution, suspension, emulsion or liquid mixture.
12. The method 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.
13. The method 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.
14. The method 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.
15. The method of claim 1 , wherein said composition is essentially free of precipitation inhibitors.
16. A method of providing a human subject pain relief within 2 hours, wherein said method comprising administering to said subject a stable oral pharmaceutical composition comprising a reduced dose of celecoxib relative to conventional celecoxib in 400 mg oral capsules a solubilizer, a medium chain glyceride, a polar solvent, and a pharmaceutically-acceptable excipient.
17. The method of claim 16 , wherein said composition comprises at least about 20% less celecoxib compared to conventional 400 mg oral celecoxib capsules.
18. The method of claim 16 , wherein said composition comprises at least about 40% less celecoxib compared to conventional 400 mg oral celecoxib capsules.
19. The method of claim 16 , wherein said composition comprises at least about 55% less celecoxib compared to conventional 400 mg oral celecoxib capsules.
20. The method of claim 16 , wherein said composition comprises at least about 70% less celecoxib compared to conventional 400 mg oral celecoxib capsules.
21. The method of claim 17 , wherein said reduced dose of celecoxib is about 320 mg.
22. The method of claim 18 , wherein said reduced dose of celecoxib is about 240 mg.
23. The method of claim 19 , wherein said reduced dose of celecoxib is about 180 mg.
24. The method of claim 20 , wherein said reduced dose of celecoxib is about 120 mg.
25. The method of claim 16 , 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.
26. The method of claim 16 , wherein said composition is in the form of a solution, suspension, emulsion or liquid mixture.
27. The method of claim 16 , 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.
28. The method of claim 16 , 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.
29. The method of claim 16 , 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.
30. The method of claim 16 , wherein said composition is essentially free of precipitation inhibitors.