PHARMACEUTICAL COMPOSITION CONTAINING CELECOXIB
Disclosed herein is a pharmaceutical composition comprising pharmaceutical formulation of complexed Celecoxib and crystalline Celecoxib to provide fast and long lasting continuous pain management with once a daily dosing. The pharmaceutical composition has improved physicochemical properties that provide faster onset of action for acute pain relief and lower GI related side effects for acute pain relief and lower GI related side effects.
1 .- 17 . (canceled)
18 . A method of treating osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain, and/or primary dysmenorrhea in a subject in need thereof, comprising administering to the subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising:
a Celecoxib complex, said complex comprising:
5-40 weight % Celecoxib,
40-80 weight % of a copolymer of vinylpirrolidone and vinyl acetate, and
5-30 weight % sodium lauryl sulfate; and
crystalline Celecoxib;
wherein the pharmaceutical composition is prepared by blending the Celecoxib complex and the crystalline Celecoxib.
19 . The method of claim 18 , wherein the pharmaceutical composition comprises 50-200 mg Celecoxib equivalent of the Celecoxib complex.
20 . The method of claim 18 , wherein the pharmaceutical composition comprises 50-400 mg crystalline Celecoxib.
21 . The method of claim 18 , wherein the pharmaceutical composition further comprises 40-20,000 mg pharmaceutically acceptable excipients.
22 . The method of claim 18 , wherein said crystalline Celecoxib is micronized Celecoxib.
23 . The method of claim 22 , wherein the main particle size of said micronized Celecoxib is in the range of between 3-10 μm.
24 . The method of claim 18 , wherein said pharmaceutical composition is suitable for oral administration.
25 . The method of claim 24 , wherein said pharmaceutical composition is suitable for the preparation of liquid dispersible granule, sachet, orally disintegrating tablet, chewing tablet, tablet for solution, tablet for suspension and immediate release tablet dosage forms.
26 . The method of claim 25 , wherein said pharmaceutical composition comprises liquid dispersible granules of the Celecoxib complex and crystalline Celecoxib.
27 . The method of claim 18 , wherein the Celecoxib complex is prepared by spray drying a solution mixture of 2-propanol and water containing celecoxib, the copolymer of vinylpirrolidone and vinyl acetate, and the sodium lauryl sulfate.
28 . A method of treating osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain, and/or primary dysmenorrhea in a subject in need thereof, comprising administering to the subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising:
a Celecoxib complex, said complex comprising:
5-40 weight % Celecoxib,
40-80 weight % of a copolymer of vinylpirrolidone and vinyl acetate, and
5-30 weight % sodium lauryl sulfate; and
crystalline Celecoxib.
29 . The method of claim 28 , wherein the pharmaceutical composition comprises 50-200 mg Celecoxib equivalent of the Celecoxib complex.
30 . The method of claim 28 , wherein the pharmaceutical composition comprises 50-400 mg crystalline Celecoxib.
31 . The method of claim 28 , wherein the pharmaceutical composition further comprises 40-20,000 mg pharmaceutically acceptable excipients.
32 . The method of claim 28 , wherein said crystalline Celecoxib is micronized Celecoxib.
33 . The method of claim 32 , wherein the main particle size of said micronized Celecoxib is in range of 3-10 μm.
34 . The method of claim 28 , wherein said pharmaceutical composition is suitable for oral administration.
35 . The method of claim 34 , wherein said pharmaceutical composition is suitable for the preparation of liquid dispersible granule, sachet, orally disintegrating tablet, chewing tablet, tablet for solution, tablet for suspension and immediate release tablet dosage forms.
36 . The method of claim 35 , wherein said pharmaceutical composition comprises liquid dispersible granules of the Celecoxib complex and crystalline Celecoxib.