Dry Powder Inhalation Drug Products Exhibiting Moisture Control Properties and Methods of Administering the Same

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 a pharmaceutical composition therein, wherein the pharmaceutical composition comprises (6α, 11β, 16α, 17α)-6, 9-difluoro-17-yl 2-furancarboxylate or a solvate thereof:
• 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%.

A drug product comprising:

• a dry powder inhalation device having a pharmaceutical composition present therein, said pharmaceutical composition comprising:
• (1) a compound which 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 or a solvate thereof;
• and (2) lactose, wherein said drug product also comprises 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 exhibits a Relative Humidity of from 20% to 40%.