Pharmaceutical compositions
A pharmaceutical composition for inhalation comprising R (+) budesonide and one or more bronchodilators, and, optionally, one or more pharmaceutically acceptable excipients is described.
1. A pharmaceutical composition for use in treatment of at least one of asthma and COPD comprising a fixed dose combination consisting of R-(+)-budesonide and arformoterol, and, optionally, one or more pharmaceutically acceptable excipients,
wherein R (+) budesonide is present in an amount ranging from 80-640 mcg and arformoterol is present in an amount ranging from 2.4-20.4 mcg; and,
wherein said fixed dose combination of the R-(+)-budesonide and arformoterol is formulated for administration once per day.
2. A pharmaceutical composition according to claim 1 , formulated as an inhalation composition.
3. A pharmaceutical composition according to claim 1 , formulated for use in a metered dose inhaler.
4. A pharmaceutical composition according to claim 3 , comprising a propellant.
5. A pharmaceutical composition according claim 1 , comprising an excipient selected from a co-solvent, an antioxidant, a surfactant, a bulking agent and a lubricant.
6. A pharmaceutical composition according to claim 1 , formulated for use as a dry powder inhalation formulation.
7. A pharmaceutical composition according to claim 1 , comprising at least one finely divided pharmaceutically acceptable carrier suitable for use in dry powder inhalation formulations.
8. A combination composition according to claim 7 , wherein said carrier includes a saccharide and/or a sugar alcohol.
9. A combination composition according to claim 1 , formulated for use as an inhalation solution.
10. A combination composition according to claim 9 , comprising an excipient selected from a wetting agent, osmotic agent, a pH regulator, a buffering agent and a complexing agent, provided in a pharmaceutically acceptable vehicle.
11. A pharmaceutical composition according to claim 1 , formulated for inhalation, for use as a nasal spray, for use as nasal drops, for use as an insufflation powder, or for use as a spray patch.
12. A pharmaceutical composition for use in treatment of at least one of asthma and COPD comprising a fixed dose combination consisting of R-(+)-budesonide and arformoterol, and, optionally, one or more pharmaceutically acceptable excipients,
formulated in a metered multi-dose container, wherein the metered multi-dose container contains (quantity/container):
R (+) Budesonide 16 mg, and
Arformoterol tartarate 0.48 mg;
wherein said fixed dose combination of the R-(+)-budesonide and arformoterol is formulated for administration once per day.
13. A pharmaceutical composition according to claim 12 , wherein the metered multi-dose container further contains one or more propellants selected from:
1,1,1,2-tetrafluoroethane,
1,1,1,2,3,3,3,-heptafluoropropane,
difluoromethane,
1,1,1-trifluoroethane,
1,1,2,2-tetrafluoroethane, and
1,1-difluoroethane.
14. A pharmaceutical composition according to claim 12 , wherein the metered multi-dose container contains (quantity/container):
R (+) Budesonide 16 mg,
Arformoterol tartarate 0.48 mg, and
1,1,1,2-tetrafluoroethane (HFA-134(a)) propellant 9.6 g.
15. A pharmaceutical composition according to claim 12 , wherein the metered multi-dose container contains (quantity/container):
R (+) Budesonide 16 mg,
Arformoterol tartarate 0.48 mg,
2% Ethanol 0.22 g,
0.22% Lecithin 0.0003 mg, and
1,1,1,2,3,3,3,-heptafluoropropane (HFA-227) propellant 11.0 g.
16. A pharmaceutical composition according to claim 12 , wherein the metered multi-dose container contains (quantity/container):
R (+) Budesonide 16 mg,
Arformoterol tartarate 0.48 mg, and
1,1,1,2,3,3,3,-heptafluoropropane (HFA-227) propellant 11.2 g.
17. A pharmaceutical composition according to claim 12 , wherein the metered multi-dose container contains (quantity/container):
R (+) Budesonide 16 mg,
Arformoterol tartarate 0.48 mg,
0.3% PEG 1000 33.6 mg,
0.001% polyvinylpyrrolidone (PVP K25) 0.11 mg, and
1,1,1,2,3,3,3,-heptafluoropropane (HFA-227) propellant 11.2 g.
18. A pharmaceutical composition according to claim 12 , comprising at least one finely divided pharmaceutically acceptable carrier suitable for use in dry powder inhalation formulations.
19. A combination composition according to claim 18 , wherein said carrier includes a saccharide and/or a sugar alcohol.
20. A combination composition according to claim 12 , formulated for use as an inhalation solution.
21. A combination composition according to claim 20 , comprising an excipient selected from a wetting agent, osmotic agent, a pH regulator, a buffering agent and a complexing agent, provided in a pharmaceutically acceptable vehicle.
22. A pharmaceutical composition according to claim 12 , formulated for inhalation, for use as a nasal spray, for use as nasal drops, for use as an insufflation powder, or for use as a spray patch.