Title:
水分制御特性を示す乾燥粉末吸入薬物製品及びその投与方法
Document Type and Number:
Japanese Patent JP5792307
Kind Code:
B2
Abstract:
A drug product comprising:
a dry powder inhalation device having a pharmaceutical composition present therein, said pharmaceutical composition comprising a compound which is (6±,11²,16±,17±)-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 exhibits a Relative Humidity of from 20% to 40%.
Inventors:
Aswania, Osama
Jung Jeon
Roche, Trevor, Charles
Whitaker,mark
Jung Jeon
Roche, Trevor, Charles
Whitaker,mark
Application Number:
JP2013525325A
Publication Date:
October 07, 2015
Filing Date:
August 31, 2011
Export Citation:
Assignee:
GLAXO GROUP LIMITED
International Classes:
A61K31/58; A61K9/14; A61K9/72; A61K47/26; A61M15/00; A61P11/00; A61P29/00; B65D81/24; B65D81/26
Domestic Patent References:
| JP2004505989A | ||||
| JP2003535782A | ||||
| JP2002532216A |
Foreign References:
| WO2008040841A1 | ||||
| WO2008135570A1 |
Other References:
View of NCT01128569 on 2010_06_04,ClinicalTrials.gov archive [online],2010年 6月 4日,[2014年5月1日検索],URL,http://clinicaltrials.gov/archive/NCT01128569/2010_06_04
View of NCT01134042 on 2010_07_16,ClinicalTrials.gov archive [online],2010年 7月16日,[2014年5月1日検索],URL,http://clinicaltrials.gov/archive/NCT01134042/2010_07_16
Guidance for Industry Metered Dose Inhaler(MDI) and Dry Powder Inhaler(DPI) Drug Products [online],U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research,1998年,[2014年5月1日検索],URL,http://www.fda.gov/downloads/Drugs/Guidances/ucm070573.pdf
View of NCT01134042 on 2010_07_16,ClinicalTrials.gov archive [online],2010年 7月16日,[2014年5月1日検索],URL,http://clinicaltrials.gov/archive/NCT01134042/2010_07_16
Guidance for Industry Metered Dose Inhaler(MDI) and Dry Powder Inhaler(DPI) Drug Products [online],U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research,1998年,[2014年5月1日検索],URL,http://www.fda.gov/downloads/Drugs/Guidances/ucm070573.pdf
Attorney, Agent or Firm:
Yusuke Hiraki
Satoshi Fujita
Eiichi Arai
Natsuo Tanaka
Satoshi Fujita
Eiichi Arai
Natsuo Tanaka
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