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DK1687019T3 - Propylengykol peptidformuleringer som er optimale til produktion og anvendelse i injektionsanordninger - Google Patents

Propylengykol peptidformuleringer som er optimale til produktion og anvendelse i injektionsanordninger Download PDF

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Publication number
DK1687019T3
DK1687019T3 DK04797453.0T DK04797453T DK1687019T3 DK 1687019 T3 DK1687019 T3 DK 1687019T3 DK 04797453 T DK04797453 T DK 04797453T DK 1687019 T3 DK1687019 T3 DK 1687019T3
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Denmark
Prior art keywords
formulation
formulations
propylene glycol
concentration
peptide
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DK04797453.0T
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English (en)
Inventor
Claude Bonde
Dorthe Kot Engelund
Tina Bjeldskov Pedersen
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Novo Nordisk As
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Publication of DK1687019T3 publication Critical patent/DK1687019T3/da

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    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin

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

Claims (17)

  1. Pateetkrav
    1. Farmaceutisk formulering omfattende peptidet Argj4, Lys26(Ns(y-Glu(N“-hexadecanoyl)))-GLP~ 1(7-37) og propylenglykol, hvor nævnte propylenglykol er til stede i nævnte formulering i en slutkoncentration fra 1 mg/ml til 100 mg/ml, og hvor nævnte formulering har en pH fra 7,0 til 10,0.
  2. 2. Formulering ifølge krav 1, hvor nævnte formulering er egnet til parenteral administration udført ved subkutan, intramuskulær eller intravenøs injektion ved hjælp af en sprøjte, eventuelt en pen-lignende sprøjte.
  3. 3. Formulering ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af propylenglykol er fra 1 mg/ml til 50 mg/ml.
  4. 4. Formulering ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af propylenglykol er fra 5 mg/ml til 25 mg/ml.
  5. 5. Formulering ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af propylenglykol er fra 8 mg/ml til 16 mg/ml.
  6. 6. Formulering ifølge et hvilket som helst af de foregående krav, hvor nævnte formulerings pH er 7,0 til 9,5.
  7. 7. Formulering ifølge et hvilket som helst af de foregående krav, hvor nævnte peptid består af Arg34, Lys26(N£(rGlu(N“-hexadecanoyl)))-GLP- l (7-37).
  8. 8. Formulering ifølge krav 7, hvor nævnte formulerings pH er 7,0 til 8,3.
  9. 9. Formulering ifølge krav 8, hvor nævnte formulerings pH er 7,3 til 8,3.
  10. 10. Formulering ifølge krav 9, hvor nævnte formulerings pH er 8,0 til 8,3.
  11. 11. Formulering ifølge et hvilket som helst af de foregående krav, yderligere omfattende et konserveringsmiddel.
  12. 12. Formulering ifølge krav 11, hvor nævnte konserveringsmiddel er til stede i en koncentration fra 0,1 mg/ml til 20 mg/ml.
  13. 13. Formulering ifølge krav 11 eller 12, hvor nævnte konserveringsmiddelet er phenol.
  14. 14. Formulering ifølge et hvilket som helst af de foregående krav, yderligere omfattende en buffer.
  15. 15. Formulering ifølge krav 14, hvor nævnte buffer er udvalgt blandt gruppen bestående af glycylglycin, natriumdihydrogenfosfat, dinatriumhydrogenfosfat, natriumfosfat eller blandinger deraf.
  16. 16. Formulering ifølge krav 14, hvor nævnte buffer er dinatriumfosfatdihydrat.
  17. 17. Formulering ifølge et hvilket som helst af de foregående krav, hvor koncentrationen af Arg34, Lys26(NE(y-Glu(Na-hexadecanoyl)))-GLP-l (7-37) er fra 0,1 mg/ml til 50 mg/ml eller fra 0,1 mg/ml til 10 mg/ml.
DK04797453.0T 2003-11-20 2004-11-18 Propylengykol peptidformuleringer som er optimale til produktion og anvendelse i injektionsanordninger DK1687019T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200301719 2003-11-20
PCT/DK2004/000792 WO2005049061A2 (en) 2003-11-20 2004-11-18 Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices

Publications (1)

Publication Number Publication Date
DK1687019T3 true DK1687019T3 (da) 2018-02-12

Family

ID=34609967

Family Applications (2)

Application Number Title Priority Date Filing Date
DK17196501.5T DK3300721T4 (da) 2003-11-20 2004-11-18 Propylenglycol-holdige peptidformuleringer hvilke er optimale til fremstilling og til anvendelse i injektionsindretninger
DK04797453.0T DK1687019T3 (da) 2003-11-20 2004-11-18 Propylengykol peptidformuleringer som er optimale til produktion og anvendelse i injektionsanordninger

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DK17196501.5T DK3300721T4 (da) 2003-11-20 2004-11-18 Propylenglycol-holdige peptidformuleringer hvilke er optimale til fremstilling og til anvendelse i injektionsindretninger

Country Status (20)

Country Link
US (5) US8114833B2 (da)
EP (3) EP3300721B2 (da)
JP (2) JP5558655B2 (da)
KR (1) KR101243648B1 (da)
CN (4) CN102784386A (da)
AU (1) AU2004290862B2 (da)
BR (1) BRPI0416743A (da)
CA (1) CA2545034C (da)
CY (1) CY1119723T1 (da)
DK (2) DK3300721T4 (da)
ES (2) ES2660320T3 (da)
FI (1) FI3300721T4 (da)
HK (1) HK1246683B (da)
HU (2) HUE043210T2 (da)
MX (1) MXPA06005581A (da)
PL (2) PL3300721T3 (da)
PT (2) PT3300721T (da)
SI (2) SI3300721T1 (da)
TR (1) TR201906789T4 (da)
WO (1) WO2005049061A2 (da)

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