Oral composition of celecoxib for treatment of pain
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° 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 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 ≥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.