Title:
INSULIN CONTAINING PHARMACEUTICAL COMPOSITIONS
Document Type and Number:
Japanese Patent JP2020105227
Kind Code:
A
Abstract:
To provide novel formulations of long acting insulin derivatives.SOLUTION: The invention relates to a pharmaceutical composition comprising an insulin derivative selected from the group consisting of: A14E, B16H, B25H, B29K((Nε-Eicosanedioyl-γGlu-[2-(2-{2-[2-(2-aminoethoxy)ethoxy]acetylamino}ethoxy)ethoxy]acetyl)), desB30 human insulin (Compound 1); A14E, B16H, B25H, B29K(Nε-Hexadecandioyl-γGlu), desB30 human insulin (Compound 2); A14E, B16H, B25H, B29K(Nε-Eicosanedioyl-γGlu), desB30 human insulin (Compound 3); and A14E, B25H, desB27, B29K(Nε-Octadecandioyl-γGlu), desB30 human insulin (Compound 4). The composition further comprises about 1 to about 2% (wt/wt) of glycerin; about 45 to about 75 mM of phenol; about 0 to about 19 mM of m-cresol; about 1.5 to about 2.5 moles of zinc ions per 6 moles of the insulin derivative; and about 75 mM or less of sodium chloride, and has a pH value in a range of about 7.2 to 8.0.SELECTED DRAWING: None
Inventors:
MATHIAS NORRMAN
SUSANNE HOSTRUP
DORTE BJERRE STEENSGAARD
HOLGER MARTIN STRAUSS
ROSA REBECCA ERRITZOE HANSEN
SVEND HAVELUND
MORTEN SCHLEIN
JESPER SONDERGAARD PEDERSEN
SUSANNE HOSTRUP
DORTE BJERRE STEENSGAARD
HOLGER MARTIN STRAUSS
ROSA REBECCA ERRITZOE HANSEN
SVEND HAVELUND
MORTEN SCHLEIN
JESPER SONDERGAARD PEDERSEN
Application Number:
JP2020068954A
Publication Date:
July 09, 2020
Filing Date:
April 07, 2020
Export Citation:
Assignee:
NOVO NORDISK AS
International Classes:
A61K38/28; A61K9/08; A61K38/26; A61K47/02; A61K47/10; A61P3/04; A61P3/06; A61P3/10; A61P43/00
Domestic Patent References:
| JP6690062B2 | 2020-04-28 | |||
| JP2002535287A | 2002-10-22 | |||
| JP2013545782A | 2013-12-26 | |||
| JP2011515358A | 2011-05-19 | |||
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| JP2011121963A | 2011-06-23 | |||
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Attorney, Agent or Firm:
Yasuhiko Murayama
Shinya Mitsuhiro
Tatsuhiko Abe
Shinya Mitsuhiro
Tatsuhiko Abe