# US 2013/0156828 A1 · Dry Powder Inhalation Drug Products Exhibiting Moisture Control Properties and Methods of Administering the Same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0156828 A1 - Document ID: US20130156828A1 - Status: Published application - Kind: A1 - Application number: 13/819,149 - Filed: 2011-08-31 - Published: 2013-06-20 - Earliest claimed: 2010-08-31 - Inventors: Osama Ahmed Aswania; Zhong Jiang; Trevor Charles Roche; Mark Whitaker - Web page: https://patentgrep.com/patent/US20130156828A1 ## CPC - A61K 47/02: Inorganic compounds - A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles} - A61K 9/145: {with organic compounds} - A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) - A61P 11/00: Drugs for disorders of the respiratory system - A61P 11/06: Antiasthmatics - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - B65B 7/00: Closing containers or receptacles after filling - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) ## Abstract A drug product comprises a dry powder inhalation device having a pharmaceutical composition present therein, said pharmaceutical composition comprising 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; 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 exhitbits a Relative Humidity of from 20% to 40%. ## Claims ### Claim 1 A drug product comprising: a dry powder inhalation device having a pharmaceutical composition present therein, said pharmaceutical composition comprising a compound which is (6α, 11β, 16α, 17α)-6,9-difluoro-17-{[(fluoromethyl)thio]carbonylyl}-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 exhitbits a Relative Humidity of from 20% to 40%. ### Claim 2 (depends on 1) The drug product according to claim 1, wherein said pharmaceutical composition comprises at least one excipient. ### Claim 3 (depends on 2) The drug product according to claim 2, wherein said at least one excipient is lactose. ### Claim 4 (depends on 1) The drug product according to claim 1, wherein said compound is (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoromethyl)thio]carbonylyl}11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate. ### Claim 5 (depends on 1) The drug product according to claim 1, wherein said hygroscopic material comprises silica gel. ### Claim 6 (depends on 5) The drug product according to claim 5, wherein the silica gel is present in an enclosure. ### Claim 7 (depends on 6) The drug product according to claim 6, wherein the silica gel is present in a sachet. ### Claim 8 (depends on 5) The drug product according to claim 5, wherein the desiccant is present in a state of partial hydration. ### Claim 9 (depends on 1) The drug product according to claim 1, wherein the dry powder inhalation device is a unit-dose device. ### Claim 10 (depends on 1) The drug product according to claim 1, wherein the dry powder inhalation device is a multi-dose device. ### Claim 11 (depends on 1) A method of treating a respiratory disorder comprising: administering to a patient by oral inhalation (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. ### Claim 12 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%. ### Claim 13 (depends on 12) A process according to claim 12, wherein a hygroscopic material is selected from the group consisting of a humectants and desiccant. ### Claim 14 (depends on 12) A process according to claim 12, wherein the hygroscopic material is contained within a sachet. ### Claim 15 (depends on 12) A process according to claim 12, wherein the humectants is selectred from a group consisting of glycerol, sorbitol, polyethylene glycol, mono- and oligomeric sugars, sodium pyroglutamate, sodium tripolyphospate, monopotassium phosphate, lactic acid and urea. ### Claim 16 (depends on 12) A process according to claim 12, 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 ### Claim 17 (depends on 12) A process according to claim 12, wherein the sachet is loose within the drug product. ### Claim 18 (depends on 12) A process according to claim 12, wherein the sachet is fixed with respect to the inhalation device. ### Claim 19 (depends on 12) A drug product produced according to the process of claim 12. ### Claim 20 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%. ### Claim 21 (depends on 20) The drug product according to claim 20, wherein the hygroscopic material is a desiccant present in the form of silica gel. ### Claim 22 (depends on 21) The drug product according to claim 21, wherein the silica gel is present as a sachet. ### Claim 23 (depends on 20) The drug product according to claim 20, wherein the dry powder inhalation device is a multi-dose device.