DRY POWDER INHALATION DRUG PRODUCTS EXHIBITING MOISTURE CONTROL PROPERTIES AND METHODS OF ADMINISTERING THE SAME

1 . A drug product comprising:

a dry powder inhalation device containing one or more pharmaceutical compositions present therein, wherein the one or more pharmaceutical compositions comprise active ingredients (I) 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol, or a salt thereof, and (II) (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoromethyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate or a solvate thereof;

a hygroscopic material; and

a package which encompasses the dry powder inhalation device and the hygroscopic material defining an enclosed volume therein;

wherein each of the active ingredients (I) and (II) are present in the same or different pharmaceutical compositions, and wherein the enclosed volume within the package exhibits a Relative Humidity of from 20% to 40%.

2 . The drug product according to claim 1 , wherein said one or more pharmaceutical compositions comprises at least one excipient.

3 . The drug product according to claim 2 , wherein said at least one excipient is lactose.

4 . The drug product according to claim 1 , wherein the compound of (I) is 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl) oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol triphenyl acetate and the compound of (II) is (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoromethyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate.

5 . The drug product according to claim 1 , wherein said hygroscopic material comprises silica gel.

6 . The drug product according to claim 5 , wherein the silica gel is present within an enclosure.

7 . The drug product according to claim 6 , wherein the silica gel is present within a packet.

8 . The drug product according to claim 1 , wherein the dry powder inhalation device is a unit-dose device.

9 . The drug product according to claim 1 , wherein the dry powder inhalation device is a multi-dose device.

10 . A drug product comprising:

a dry powder inhalation device containing two pharmaceutical compositions present therein, wherein one of said two pharmaceutical compositions comprise active ingredient (I) 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol, or a salt thereof, and the other of said two pharmaceutical compositions comprise active ingredient (II) (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoromethyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate or a solvate thereof; a hygroscopic material; and a package which encompasses the dry powder inhalation device and the hygroscopic material defining an enclosed volume therein; wherein the enclosed volume within the package exhibits a Relative Humidity of from 20% to 40%.

11 . A method of treating a respiratory disorder comprising:

administering to a patient by oral inhalation a compound of (I) 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl) phenol, or a salt thereof, and a compound of (II) (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoromethyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate or a solvate thereof, using the drug product of Claim 1 .

12 . The method according to claim 11 , wherein the compounds of (I) and (II) are administered simultaneously.

13 . The method according to claim 11 , wherein the compounds of (I) and (II) are administered sequentially.

14 . The method according to claim 11 , wherein the compounds of (I) and (II) are administered separately.

15 . A process of producing a drug product comprising:

subjecting a hygroscopic material to moisture exposure sufficient to attain a predetermined relative humidity;

combining the hygroscopic material with an inhalation device containing one or more pharmaceutical compositions therein, wherein the one or more pharmaceutical compositions comprise active ingredients (I) 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol, or a salt thereof, and (II) (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoromethyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate or a solvate thereof; wherein each of the active ingredients (I) and (II) are present in the same or different pharmaceutical compositions, and

enclosing the dry powder inhalation device and hygroscopic material within a package to define an enclosed volume therein forming a drug product and wherein the hydration level of the hygroscopic material is such that enclosed volume has a Relative Humidity of from 20% to 40%.

16 . A process according to claim 15 , wherein a hygroscopic material is selected from the group consisting of a humectant and desiccant.

17 . A process according to claim 15 , wherein the hygroscopic material is present within a packet.

18 . A process according to claim 15 , wherein the humectant is selected from a group consisting of glycerol, sorbitol, polyethylene glycol, mono- and oligomeric sugars, sodium pyroglutamate, sodium tripolyphosphate, monopotassium phosphate, lactic acid and urea.

19 . A process according to claim 15 , wherein the desiccant is selected from a group consisting of montmorillonite clay, silica gel, crystalline aluminosilicates, calcium oxide, calcium sulfate, activated alumina, metal salts and phosphorus compounds.

20 . A process according to claim 15 , wherein the packet is loose within the drug product.

21 . A process according to claim 15 , wherein the packet is fixed with respect to the inhalation device.

22 . A drug product produced according to the process of claim 15