EP 2117504 A1 20091118 - STABLE PHARMACEUTICAL DRUG AEROSOLS
Title (en)
STABLE PHARMACEUTICAL DRUG AEROSOLS
Title (de)
STABILE PHARMAZEUTISCHE WIRKSTOFF-AEROSOLE
Title (fr)
AÉROSOLS DE MÉDICAMENTS PHARMACEUTIQUES STABLES
Publication
Application
Priority
US 2007003637 W 20070209
Abstract (en)
[origin: WO2008097233A1] Various aspects of the present invention provide for methods of manufacturing a pharmaceutical drug product, which include storing a container at a temperature greater than ambient conditions for at least about seven days and conducting release testing on the container after storing. Products manufactured by this method have a more consistent fine particle size distribution (FSD) and fine particle fraction (FPF) at ambient conditions and at accelerated stability conditions over the life of the drug product. Advantageously, such products may more reliably and regularly pass testing requirements as required for an approved drug product by regulatory authorities such as the United States Food and Drug Administration (USFDA).
IPC 8 full level
A61K 9/00 (2006.01); A61K 9/12 (2006.01); A61K 31/58 (2006.01)
CPC (source: EP KR)
A61K 9/008 (2013.01 - EP); A61K 9/12 (2013.01 - KR); A61K 31/167 (2013.01 - EP); A61K 31/58 (2013.01 - EP KR); A61P 11/06 (2017.12 - EP)
Citation (search report)
See references of WO 2008097233A1
Designated contracting state (EPC)
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR
Designated extension state (EPC)
AL BA HR MK RS
DOCDB simple family (publication)
WO 2008097233 A1 20080814; AU 2007346134 A1 20080814; BR PI0721256 A2 20130312; CA 2677347 A1 20080814; CN 101652123 A 20100217; EP 2117504 A1 20091118; EP 2444080 A2 20120425; EP 2444080 A3 20120502; JP 2010518076 A 20100527; KR 20100004993 A 20100113; MX 2009008572 A 20091019; NO 20092977 L 20091102
DOCDB simple family (application)
US 2007003637 W 20070209; AU 2007346134 A 20070209; BR PI0721256 A 20070209; CA 2677347 A 20070209; CN 200780052493 A 20070209; EP 07750471 A 20070209; EP 12151231 A 20070209; JP 2009549054 A 20070209; KR 20097018157 A 20070209; MX 2009008572 A 20070209; NO 20092977 A 20090908