DK2597103T3 - Stable pharmaceutical compositions comprising liraglutide and degludec - Google Patents

Stable pharmaceutical compositions comprising liraglutide and degludec Download PDF

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Publication number
DK2597103T3
DK2597103T3 DK13155712.6T DK13155712T DK2597103T3 DK 2597103 T3 DK2597103 T3 DK 2597103T3 DK 13155712 T DK13155712 T DK 13155712T DK 2597103 T3 DK2597103 T3 DK 2597103T3
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Prior art keywords
insulin
zinc
glp
pharmaceutical composition
analogue
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DK13155712.6T
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English (en)
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Anne Plum
Dorte Bjerre Steensgaard
Jens Kaalby Thomsen
Morten Schlein
Anne Sofie Kjaer Marcussen
Christian Poulsen
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Novo Nordisk As
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/605—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/62—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Engineering & Computer Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Claims (9)

  1. PATENTKRAY
    1. Opløselig farmaceutisk sammensætning til parental indgivelse, omfattende en insulinotropisk GLP-1 sammensætning, en basal insulinpeptid, farmaceutisk acceptable tilsætningsstoffer og zink, hvorved zink-indholdet andrager mellem 6 Zn-ioner per 6 insulinmolekyler og 12 Zn-ioner per 6 insulinmolekyler, hvorved det ved den insulinotrope GLP-1 forbindelse drejer sig om Arg34, Lys26(N£ - (y-Glu(Na-hexadecanoyl)))-GLP-l(7-37), og det ved det basale insulinpeptid drejer sig om ΝεΒ29 -(N“ -(HOOC(CH2)i4CO)-a-Glu) desB30 human insulin, og hvorved pH for den farmaceutiske sammensætning er mellem pH7 og pH9.
  2. 2. Farmaceutisk sammensætning ifølge krav 1, hvorved zink-indholdet er mellem 6 og 10 zink-ioner per 6 insulin-molekyler.
  3. 3. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, hvorved zink-indholdet er mellem 7 og 10 zink-ioner per 6 insulinmolekyler.
  4. 4. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, hvorved pH for den farmaceutiske sammensætning er mellem ph 7,7 og pH 8,9.
  5. 5. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, hvorved pH for den farmaceutiske sammensætning er mellem pH 7,7 og pH 8,5.
  6. 6. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, hvorved pH for den farmaceutiske sammensætning er 8,2, 8,3, 8,4 eller 8,5.
  7. 7. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, hvorved koncentrationen af den basale insulin ligger i intervallet mellem 1,5 og 8 mg/ml, og koncentrationen af GLP-1 sammensætningen ligger i intervallet mellem 2 og 10 mg/ml.
  8. 8. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, hvorved de farmaceutisk acceptable additiver omfatter et konserveringsstof, hvor det drejer sig om fenol.
  9. 9. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, og som desuden omfatter histidin.
DK13155712.6T 2007-11-16 2008-11-14 Stable pharmaceutical compositions comprising liraglutide and degludec DK2597103T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP07120880 2007-11-16
EP08849536.1A EP2209800B1 (en) 2007-11-16 2008-11-14 Stable pharmaceutical compositions comprising liraglutide and degludec

Publications (1)

Publication Number Publication Date
DK2597103T3 true DK2597103T3 (da) 2017-02-13

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DK13155712.6T DK2597103T3 (da) 2007-11-16 2008-11-14 Stable pharmaceutical compositions comprising liraglutide and degludec

Country Status (15)

Country Link
US (1) US8937042B2 (da)
EP (2) EP2209800B1 (da)
JP (2) JP5241849B2 (da)
CN (3) CN107412742B (da)
BR (1) BRPI0820535B8 (da)
CA (1) CA2705821A1 (da)
DK (1) DK2597103T3 (da)
ES (2) ES2612736T3 (da)
HU (2) HUE030383T2 (da)
MX (1) MX2010005245A (da)
NO (1) NO2017015I1 (da)
PL (2) PL2597103T3 (da)
PT (1) PT2597103T (da)
WO (1) WO2009063072A2 (da)
ZA (1) ZA201003019B (da)

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