Claims
- 1. A pharmaceutical composition comprising:
(a) a tiotropium salt; and (b) an antihistamine, optionally together with a pharmaceutically acceptable excipient, the tiotropium salt and the antihistamine optionally in the form of their enantiomers, mixtures of their enantiomers, their racemates, their solvates, or their hydrates.
- 2. The pharmaceutical composition according to claim 1, wherein the tiotropium salt is a salt with a counter-ion selected from chloride, bromide, iodide, p-toluene sulfonate, or methylsulfate.
- 3. The pharmaceutical composition of claim 2, wherein the counter-ion is bromide.
- 4. The pharmaceutical composition according to claim 1, wherein the antihistamine is selected from the group consisting of: epinastine, cetirizine, azelastine, fexofenadine, levocabastine, loratadine, mizolastine, ketotifen, emedastine, dimethindene, clemastine, bamipine, dexchlorpheniramine, pheniramine, doxylamine, chlorphenoxamine, dimenhydrinate, diphenhydramine, promethazine, ebastine, desloratadine, and meclozine.
- 5. The pharmaceutical composition according to claim 2, wherein the antihistamine is selected from the group consisting of: epinastine, cetirizine, azelastine, fexofenadine, levocabastine, loratadine, mizolastine, ketotifen, emedastine, dimethindene, clemastine, bamipine, dexchlorpheniramine, pheniramine, doxylamine, chlorphenoxamine, dimenhydrinate, diphenhydramine, promethazine, ebastine, desloratadine, and meclozine.
- 6. The pharmaceutical composition according to claim 3, wherein the antihistamine is selected from the group consisting of: epinastine, cetirizine, azelastine, fexofenadine, levocabastine, loratadine, mizolastine, ketotifen, emedastine, dimethindene, clemastine, bamipine, dexchlorpheniramine, pheniramine, doxylamine, chlorphenoxamine, dimenhydrinate, diphenhydramine, promethazine, ebastine, desloratadine, and meclozine.
- 7. The pharmaceutical composition according to claim 3, wherein the antihistamine is selected from the group consisting of: epinastine, cetirizine, azelastine, fexofenadine, levocabastine, loratadine, ebastine, desloratadine and mizolastine.
- 8. The pharmaceutical composition according to claim 1, wherein the weight ratios of the tiotropium salt to the antihistamine are in the range of from 1:300 to 50:1.
- 9. The pharmaceutical composition according to claim 8, wherein the weight ratios of the tiotropium salt to the antihistamine are in the range of from 1:250 to 40:1.
- 10. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is an inhalable powder, a propellant-containing metering aerosol, or a propellant-free inhalable solution or suspension.
- 11. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition further comprises a suitable physiologically acceptable excipient selected from the group consisting of: monosaccharides, disaccharides, oligo- and polysaecharides, polyalcohols, and salts.
- 12. The pharmaceutical composition according to claim 2, wherein the pharmaceutical composition further comprises a suitable physiologically acceptable excipient selected from the group consisting of: monosaccharides, disaccharides, oligo- and polysaccharides, polyalcohols, and salts.
- 13. The pharmaceutical composition of claim 11, wherein the excipient has a maximum average particle size of up to 250 μm.
- 14. The pharmaceutical composition of claim 12, wherein the excipient has a maximum average particle size of up to 250 μm.
- 15. The pharmaceutical composition of claim 13, wherein the excipient has a maximum average particle size of between 10 μm and 150 μm.
- 16. The pharmaceutical composition of claim 14, wherein the excipient has a maximum average particle size of between 10 μm and 150 μm.
- 17. A capsule containing a pharmaceutical composition according to claim 1 in the form of an inhalable powder.
- 18. A capsule containing a pharmaceutical composition according to claim 2 in the form of an inhalable powder.
- 19. A capsule containing a pharmaceutical composition according to claim 3 in the form of an inhalable powder.
- 20. A capsule containing a pharmaceutical composition according to claim 4 in the form of an inhalable powder.
- 21. A capsule containing a pharmaceutical composition according to claim 5 in the form of an inhalable powder.
- 22. A capsule containing a pharmaceutical composition according to claim 6 in the form of an inhalable powder.
- 23. A capsule containing a pharmaceutical composition according to claim 7 in the form of an inhalable powder.
- 24. A capsule containing a pharmaceutical composition according to claim 8 in the form of an inhalable powder.
- 25. A capsule containing a pharmaceutical composition according to claim 9 in the form of an inhalable powder.
- 26. A capsule containing a pharmaceutical composition according to claim 10 in the form of an inhalable powder.
- 27. A capsule containing a pharmaceutical composition according to claim 11 in the form of an inhalable powder.
- 28. A capsule containing a pharmaceutical composition according to claim 12 in the form of an inhalable powder.
- 29. A capsule containing a pharmaceutical composition according to claim 13 in the form of an inhalable powder.
- 30. A capsule containing a pharmaceutical composition according to claim 14 in the form of an inhalable powder.
- 31. A capsule containing a pharmaceutical composition according to claim 15 in the form of an inhalable powder.
- 32. A capsule containing a pharmaceutical composition according to claim 16 in the form of an inhalable powder.
- 33. A pharmaceutical composition according to claim 1, where in the pharmaceutical composition is a propellant-containing inhalable aerosol and the tiotropium salt and the antihistamine are in dissolved or dispersed form.
- 34. The pharmaceutical composition according to claim 33, wherein the propellant-containing inhalable aerosol comprises a propellant gas selected from hydrocarbons and halohydrocarbons.
- 35. The pharmaceutical composition according to claim 33, wherein the propellant-containing inhalable aerosol comprises a propellant gas selected from the group consisting of: n-propane; n-butane; isobutane; and chlorinated and/or fluorinated derivatives of methane, ethane, propane, butane, cyclopropane, and cyclobutane.
- 36. The pharmaceutical composition according to claim 34, wherein the propellant gas is TG134a, TG227, or a mixture thereof.
- 37. The pharmaceutical composition according to claim 33, further comprising at least one of a cosolvent, stabilizer, surfactant, antioxidant, lubricant, or means for adjusting the pH of the composition.
- 38. The pharmaceutical composition according to claim 34, further comprising at least one of a cosolvent, stabilizer, surfactant, antioxidant, lubricant, or means for adjusting the pH of the composition.
- 39. The pharmaceutical composition according to claim 35, further comprising at least one of a cosolvent, stabilizer, surfactant, antioxidant, lubricant, or means for adjusting the pH of the composition.
- 40. The pharmaceutical composition according to claim 36, further comprising at least one of a cosolvent, stabilizer, surfactant, antioxidant, lubricant, or means for adjusting the pH of the composition.
- 41. The pharmaceutical composition according to claim 33, where in the amount of the tiotropium salt or the antihistamine is up to 5 wt. % of the pharmaceutical composition.
- 42. A pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is propellant-free inhalable solution or suspension that further comprises a solvent selected from water, ethanol, or a mixture of water and ethanol.
- 43. The pharmaceutical composition according to claim 42, wherein the pH is between 2 and 7.
- 44. The pharmaceutical composition according to claim 43, wherein the pH is between 2 and 5.
- 45. The pharmaceutical composition according to claim 42, wherein the pH of the pharmaceutical composition is adjusted by means of one or more acids selected from the group consisting of: hydrochloric acid, hydrobromic acid, nitric acid, sulfuric acid, ascorbic acid, citric acid, malic acid, tartaric acid, maleic acid, succinic acid, fumaric acid, acetic acid, formic acid, and propionic acid.
- 46. The pharmaceutical composition according to claim 42, further comprising other co-solvents or excipients.
- 47. The pharmaceutical composition according to claim 45, further comprising other co-solvents or excipients.
- 48. The pharmaceutical composition according to claim 46, wherein the co-solvent is selected from the group consisting of alcohols, glycols, polyoxyethylene alcohols, and polyoxyethylene fatty acid esters.
- 49. The pharmaceutical composition according to claim 46, wherein the co-solvent is selected from the group consisting of: isopropyl alcohol, propylene glycol, polyethylene glycol, polypropylene glycol, glycol ether, and glycerol.
- 50. The pharmaceutical composition according to claim 46, wherein the excipient is selected from the group consisting of: surfactants, stabilizers, complexing agents, antioxidants, preservatives, flavorings, pharmacologically acceptable salts, and vitamins.
- 51. The pharmaceutical composition according to claim 50, wherein the excipient is selected from the group consisting of: edetic acid, a salt of edetic acid, ascorbic acid, vitamin A, vitamin E, tocopherols, cetyl pyridinium chloride, benzalkonium chloride, benzoic acid, and benzoate salts.
- 52. A pharmaceutical composition consisting essentially of:
(a) a tiotropium salt; (b) an antihistamine; (c) a solvent; (d) benzalkonium chloride; and (e) sodium edetate.
- 53. A pharmaceutical composition consisting essentially of:
(a) a tiotropium salt; (b) an antihistamine; (c) a solvent; and (d) benzalkonium chloride.
- 54. A method of treating allergic or non-allergic rhinitis in a patient in need of such treatment, the method comprising administering to the patient a therapeutically effective amount of the pharmaceutical composition according to one of claims 1 to 12.
- 55. A kit comprising one or more unit dosage containers containing a pharmaceutical composition, each unit dosage container containing a pharmaceutical composition comprising:
(a) a tiotropium salt; and (b) an antihistamine, each optionally together with a pharmaceutically acceptable excipient, the tiotropium salt and the antihistamine optionally in the form of their enantiomers, mixtures of their enantiomers, their racemates, their solvates, or their hydrates.
- 56. The kit according to claim 55, further comprising instructions with directions for using the kit.
- 57. A kit comprising:
(a) a first container containing a first pharmaceutical formulation comprising a tiotropium salt; and (b) a second container containing a second pharmaceutical formulation comprising a comprising an antihistamine, each container each optionally further containing a pharmaceutically acceptable excipient, the tiotropium salt and the antihistamine optionally in the form of their enantiomers, mixtures of their enantiomers, their racemates, their solvates, or their hydrates.
- 58. The kit according to claim 57, further comprising instructions with directions for using the kit.
Priority Claims (2)
Number |
Date |
Country |
Kind |
100 54 042.2 |
Oct 2000 |
DE |
|
101 38 272.3 |
Aug 2001 |
DE |
|
RELATED APPLICATIONS
[0001] Benefit under 35 U.S.C. §119(e) of prior provisional application Serial No. 60/253,613, filed Nov. 28, 2000, and prior provisional application Serial No. 60/314,599, filed Aug. 24, 2001, is hereby claimed.
Provisional Applications (2)
|
Number |
Date |
Country |
|
60253613 |
Nov 2000 |
US |
|
60314599 |
Aug 2001 |
US |