Claims
- 1. An orally deliverable pharmaceutical composition comprising (a) a drug of low water solubility in a therapeutically and/or prophylactically effective amount and (b) a solvent liquid that comprises at least one pharmaceutically acceptable polyethylene glycol and at least one pharmaceutically acceptable free radical-scavenging antioxidant, wherein a substantial portion of the drug is in dissolved or solubilized form in the solvent liquid, and wherein the drug comprises an aminosulfonyl functional group and/or is capable of reacting with a polyethylene glycol or with a polyethylene glycol degradation product to form an addition compound.
- 2. The composition of claim 1 wherein the drug is a selective cyclooxygenase-2 inhibitory drug.
- 3. The composition of claim 2 wherein the selective cyclooxygenase-2 inhibitory drug is a compound of formula
- 4. The composition of claim 3 wherein the five- to six-membered ring is selected from the group consisting of cyclopentenone, furanone, methylpyrazole, isoxazole and pyridine rings substituted at no more than one position.
- 5. The composition of claim 2 wherein the drug is selected from the group consisting of celecoxib, deracoxib, valdecoxib and JTE-522.
- 6. The composition of claim 2 wherein the drug is celecoxib.
- 7. The composition of claim 2 wherein the drug is valdecoxib.
- 8. The composition of claim 2 that further comprises a vasomodulator, wherein the selective cyclooxygenase-2 inhibitory drug and the vasomodulator are present in total and relative amounts effective to relieve pain in headache or migraine.
- 9. The composition of claim 2 that further comprises an alkylxanthine compound, wherein the selective cyclooxygenase-2 inhibitory drug and the alkylxanthine compound are present in total and relative amounts effective to relieve pain in headache or migraine.
- 10. The composition of claim 9 wherein the alkylxanthine compound is caffeine.
- 11. The composition of claim 1 wherein the polyethylene glycol has an average molecular weight of about 100 to about 10,000.
- 12. The composition of claim 1 wherein the polyethylene glycol is of liquid grade.
- 13. The composition of claim 1 wherein the at least one free radical-scavenging antioxidant is present in the solvent liquid in a total amount of about 0.01% to about 5% by weight of the composition.
- 14. The composition of claim 1 wherein the at least one free radical-scavenging antioxidant is present in the solvent liquid in a total amount of about 0.01% to about 1% by weight of the composition.
- 15. The composition of claim 1 wherein the at least one free radical-scavenging antioxidant is selected from the group consisting of vitamin E, ascorbic acid and salts thereof, butylated hydroxyanisole, butylated hydroxytoluene, fumaric acid and salts thereof, hypophosphorous acid, malic acid, alkyl gallates, sodium thiosulfate, sodium sulfite, sodium bisulfite and sodium metabisulfite.
- 16. The composition of claim 1 wherein the at least one free radical-scavenging antioxidant is propyl gallate.
- 17. The composition of claim 1 wherein the at least one free radical-scavenging antioxidant is vitamin E.
- 18. The composition of claim 1 wherein substantially all of the drug present in the composition is in dissolved or solubilized form.
- 19. The composition of claim 1 wherein the solvent liquid further comprises a turbidity-decreasing polymer.
- 20. The composition of claim 19 wherein the at least one turbidity-decreasing polymer is hydroxypropylmethylcellulose.
- 21. The composition of claim 1 wherein the solvent liquid further comprises at least one pharmaceutically acceptable fatty acid and at least one pharmaceutically acceptable organic amine.
- 22. The composition of claim 21 wherein the at least one fatty acid is oleic acid.
- 23. The composition of claim 21 wherein the at least one organic amine is a tertiary amine selected from the group consisting of triethanolamine and dimethylaminoethanol.
- 24. The composition of claim 1 that comprises one or more discrete dose units, wherein a therapeutically and/or prophylactically effective amount of the drug is contained in one to a small plurality of said dose units.
- 25. The composition of claim 24 wherein each dose unit is a liquid-filled capsule having a capsule wall.
- 26. The composition of claim 25 wherein the capsule wall comprises a turbidity-decreasing polymer.
- 27. The composition of claim 26 wherein the turbidity-decreasing polymer is hydroxypropylmethylcellulose.
- 28. A method of treating a medical condition or disorder in a subject where treatment with a cyclooxygenase-2 inhibitor is indicated, comprising orally administering to the subject a composition of claim 2.
- 29. A method of analgesia comprising orally administering an effective pain-relieving amount of a composition of claim 2 to a subject in need of analgesia.
- 30. The method of claim 29 wherein the subject suffers from headache or migraine and wherein there is further orally administered to the subject a vasomodulator, the selective cyclooxygenase-2 inhibitory drug and the vasomodulator being administered in total and relative amounts effective to relieve pain in the headache or migraine.
- 31. The method of claim 29 wherein the subject suffers from headache or migraine and wherein there is further orally administered to the subject an alkylxanthine compound, the selective cyclooxygenase-2 inhibitory drug and the alkylxanthine compound being administered in total and relative amounts effective to relieve pain in the headache or migraine.
- 32. A method of use of a composition of claim 2 in manufacture of a medicament useful for treating a medical condition or disorder in a subject where treatment with a cyclooxygenase-2 inhibitor is indicated.
Parent Case Info
[0001] This application claims priority of U.S. provisional patent application Serial No. 60/284,589 filed on Apr. 17, 2001, and of U.S. provisional patent application Serial No. 60/357,959 filed on Feb. 19, 2002.
Provisional Applications (2)
|
Number |
Date |
Country |
|
60284589 |
Apr 2001 |
US |
|
60357959 |
Feb 2002 |
US |