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 comprising R (+) budesonide and one or more bronchodilators, and, optionally, one or more pharmaceutically acceptable excipients.
2 . A pharmaceutical composition according to claim 1 , wherein R (+) budesonide in an amount ranging from 80-640 mcg.
3 . A pharmaceutical composition according to claim 1 , wherein the bronchodilator comprises one or more beta 2 -agonists.
4 . A pharmaceutical composition according to claim 3 , wherein the beta 2 -agonist is selected from albuterol, levoalbuterol, terbutaline, pirbuterol, procaterol, metaproterenol, fenoterol, bitolterol mesylate, ritodrine, salmeterol, formoterol, arformoterol, carmoterol, bambuterol, clenbuterol, indacaterol, milveterol, vilanterol, olodaterol or a combination thereof.
5 . A pharmaceutical composition according to claim 3 , wherein the beta 2 -agonist comprises formoterol.
6 . A pharmaceutical composition according to claim 3 , wherein the beta 2 -agonist comprises arformoterol
7 . A pharmaceutical composition according to claim 3 , wherein the beta 2 -agonist comprises salmeterol.
8 . A pharmaceutical composition according to claim 3 , wherein the beta 2 -agonist comprises carmoterol.
9 . A pharmaceutical composition according to claim 3 , wherein carmoterol is in an amount ranging from 1 mcg-4 mcg.
10 . A pharmaceutical composition according to claim 3 , wherein the beta 2 -agonist comprises indacaterol.
11 . A pharmaceutical composition according to claim 3 , wherein indacaterol is in an amount ranging from 50 mcg-800 mcg.
12 . A pharmaceutical composition according to claim 1 , wherein the bronchodilator comprises one or more anticholinergics.
13 . A pharmaceutical composition according to claim 12 , wherein the anticholinergic is selected from tiotropium, ipratropium, oxitropium and combinations thereof.
14 . A pharmaceutical composition according to claim 12 , wherein the anticholinergic comprises tiotropium.
15 . A pharmaceutical composition according to claim 12 , wherein tiotropium is in an amount ranging from 9 mcg-18 mcg.
16 . A pharmaceutical composition according to claim 12 , wherein the anticholinergic comprises oxitropium.
17 . A pharmaceutical composition according to claim 12 , wherein the anticholinergic comprises ipratropium.
18 . A pharmaceutical composition according to claim 1 , wherein the bronchodilator comprises one or more beta 2 -agonists and/or one or more anticholinergics.
19 . A pharmaceutical composition according to claim 1 , comprising R (+) budesonide and formoterol.
20 . A pharmaceutical composition according to claim 1 , comprising R (+) budesonide and arformoterol
21 . A pharmaceutical composition according to claim 1 , comprising R (+) budesonide, tiotropium and carmoterol.
22 . A pharmaceutical composition according to claim 1 , comprising R (+) budesonide, tiotropium and indacaterol.
23 . A pharmaceutical composition according to claim 1 , wherein R (+) budesonide and beta 2 -agonists along with any excipients are formulated in a single pharmaceutical composition.
24 . A pharmaceutical composition according to claim 1 , wherein R (+) budesonide and anticholinergics along with any excipients are formulated in a single pharmaceutical composition.
25 . A pharmaceutical composition according to claim 1 , wherein beta 2 -agonists and anticholinergics along with any excipients are formulated in a single pharmaceutical composition.
26 . A pharmaceutical composition according to claim 1 , wherein R (+) budesonide, beta 2 -agonists and anticholinergics along with any excipients are formulated in a single pharmaceutical composition.
27 . A pharmaceutical composition according to claim 1 , formulated as an inhalation composition.
28 . A pharmaceutical composition according to claim 1 , formulated for use in a metered dose inhaler.
29 . A pharmaceutical composition according to claim 27 , further comprising a propellant.
30 . A pharmaceutical composition according to claim 27 , further comprising an excipient selected from a cosolvent, an antioxidant, a surfactant, a bulking agent and a lubricant.
31 . A pharmaceutical composition according to claim 1 , formulated for use as a dry powder inhalation formulation.
32 . A pharmaceutical composition according to claim 31 , further comprising at least one finely divided pharmaceutically acceptable carrier suitable for use in dry powder inhalation formulations.
33 . A combination composition according to claim 32 , wherein said carrier includes a saccharide and/or a sugar alcohol.
34 . A combination composition according to claim 32 , formulated for use as an inhalation solution.
35 . A combination composition according to claim 34 , further 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.
36 . 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.
37 . A pharmaceutical composition according to claim 1 for once daily administration.
38 . A pharmaceutical composition according to claim 1 further comprising one or more active(s) selected from antihistamines, antiallergics or leukotriene antagonist or their pharmaceutically acceptable salts, solvates, tautomers, derivatives, enantiomers, isomers, hydrates, prodrugs or polymorphs thereof.
39 . A process for manufacturing a pharmaceutical composition according to claim 1 comprising combining R (+) budesonide with one or more bronchodilators and one or more optional pharmaceutically acceptable excipients.
40 . A method of prophylaxis or treatment of a respiratory, inflammatory or obstructive airway disease, comprising administering a therapeutically effective amount of a pharmaceutical composition according to claim 1 to a patient in need thereof.
41 . A method according to claim 40 , wherein said pharmaceutical composition is administered once daily.
42 . A method according to claim 40 , wherein the disease is COPD or asthma.