JP2018528242A5 - - Google Patents

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JP2018528242A5
JP2018528242A5 JP2018515619A JP2018515619A JP2018528242A5 JP 2018528242 A5 JP2018528242 A5 JP 2018528242A5 JP 2018515619 A JP2018515619 A JP 2018515619A JP 2018515619 A JP2018515619 A JP 2018515619A JP 2018528242 A5 JP2018528242 A5 JP 2018528242A5
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Japan
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formulation
aprotic solvent
ionization
glucagon peptide
salt
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JP2018515619A
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Japanese (ja)
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JP6835831B2 (ja
JP2018528242A (ja
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Priority claimed from US15/136,650 external-priority patent/US9649364B2/en
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JP2018515619A 2015-09-25 2016-09-25 非プロトン性極性溶媒中の安定な治療用グルカゴン製剤を製造するための方法 Active JP6835831B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562233032P 2015-09-25 2015-09-25
US62/233,032 2015-09-25
US15/136,650 2016-04-22
US15/136,650 US9649364B2 (en) 2015-09-25 2016-04-22 Methods for producing stable therapeutic formulations in aprotic polar solvents
PCT/US2016/053628 WO2017053922A1 (en) 2015-09-25 2016-09-25 Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents

Publications (3)

Publication Number Publication Date
JP2018528242A JP2018528242A (ja) 2018-09-27
JP2018528242A5 true JP2018528242A5 (enExample) 2019-09-12
JP6835831B2 JP6835831B2 (ja) 2021-02-24

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JP2018515619A Active JP6835831B2 (ja) 2015-09-25 2016-09-25 非プロトン性極性溶媒中の安定な治療用グルカゴン製剤を製造するための方法

Country Status (17)

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US (6) US9649364B2 (enExample)
EP (2) EP4327804B1 (enExample)
JP (1) JP6835831B2 (enExample)
KR (2) KR102662530B1 (enExample)
CN (2) CN115531523A (enExample)
AU (1) AU2016326749B2 (enExample)
CA (2) CA3204984A1 (enExample)
DK (2) DK4327804T3 (enExample)
EA (1) EA201890704A1 (enExample)
ES (2) ES3055702T3 (enExample)
IL (1) IL258298B (enExample)
MX (1) MX2018003705A (enExample)
PL (1) PL4327804T3 (enExample)
PT (1) PT4327804T (enExample)
SA (1) SA518391187B1 (enExample)
WO (1) WO2017053922A1 (enExample)
ZA (2) ZA201801912B (enExample)

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