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° 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.

What is claimed is: 
     
         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 . The method according to  claim 1 , where the human subject attains pain freedom at 2 hours by at least 40% compared to the human subject treated with a placebo. 
     
     
         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 . The method of  claim 1 , wherein said composition said composition is in the form of a solution, suspension, emulsion or liquid mixture. 
     
     
         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 . The method according to  claim 13 , where the human subject attains pain freedom at 2 hours by at least 30% compared to the human subject treated with a placebo. 
     
     
         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 . The method of  claim 13 , wherein said composition said composition is in the form of a solution, suspension, emulsion or liquid mixture.