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 a therapeutically effective amount of celecoxib and at least one medium chain glyceride, wherein said composition leads to freedom from pain at 2 hours following administration.
2 . (canceled)
3 . The method of claim 1 , wherein said pain freedom is at least about 10% greater in comparison to the percentage of human subjects being treated with commercially available treatment like VIOXX 25 (25 mg).
4 . The method of claim 1 , wherein said pain freedom is at least about 10% greater in comparison to the percentage of human subjects being treated with commercially available treatment like VIOXX 50 (50 mg).
5 . The method of claim 1 , wherein said pain freedom is at least about 10% greater in comparison to the percentage of human subjects being treated with commercially available treatment like CAMBIA 50 (50 mg).
6 . The method of claim 1 , wherein said pain freedom is maintained for at least about 2 hours to about 24 hours.
7 . 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, primary dysmenorrhea pain, breakthrough pain, or any kind of cancer pain.
8 . The method of claim 1 , wherein said therapeutically effective amount of celecoxib is about 80 mg to about 300 mg.
9 . The method of claim 1 , wherein said therapeutically effective amount of celecoxib is about 120 mg to about 240 mg.
10 . The method of claim 1 , wherein said composition further comprises at least one solubilizer.
11 . The method of claim 1 , wherein said composition further comprises at least one polar solvent.
12 . (canceled)
13 . 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 a therapeutically effective amount of celecoxib and at least one medium chain glyceride, wherein said composition leads to partial pain relief less than 2 hours following administration.
14 . (canceled)
15 . The method of claim 13 , wherein said partial pain relief is at least about 10% greater in comparison to the percentage of human subjects being treated with commercially available treatment like VIOXX 25 (25 mg).
16 . The method of claim 13 , wherein said partial pain relief is at least about 10% greater in comparison to the percentage of human subjects being treated with commercially available treatment like VIOXX 50 (50 mg).
17 . The method of claim 13 , wherein said partial pain relief is at least about 10% greater in comparison to the percentage of human subjects being treated with commercially available treatment like CAMBIA 50 (50 mg).
18 . The method of claim 13 , wherein said partial pain relief is maintained for at least about 4 hours.
19 . The method of claim 13 , 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, primary dysmenorrhea pain, breakthrough pain, or any kind of cancer pain.
20 . The method of claim 13 , wherein said therapeutically effective amount of celecoxib is about 80 mg to about 300 mg.
21 . The method of claim 13 , wherein said therapeutically effective amount of celecoxib is about 120 mg to about 240 mg.
22 . The method of claim 13 , wherein said composition further comprises at least one solubilizer.
23 . The method of claim 13 , wherein said composition further comprises at least one polar solvent.
24 . (canceled)