SI1687019T1 - Propilen gliko-ki vsebuje peptidne formulacije, ki so optimalne za proizvodnjo in za uporabo v injekcijskih napravah - Google Patents

Propilen gliko-ki vsebuje peptidne formulacije, ki so optimalne za proizvodnjo in za uporabo v injekcijskih napravah Download PDF

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Publication number
SI1687019T1
SI1687019T1 SI200432419T SI200432419T SI1687019T1 SI 1687019 T1 SI1687019 T1 SI 1687019T1 SI 200432419 T SI200432419 T SI 200432419T SI 200432419 T SI200432419 T SI 200432419T SI 1687019 T1 SI1687019 T1 SI 1687019T1
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formulation
propylene glycol
concentration
formulation according
production
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SI200432419T
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English (en)
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Tina Bjeldskov Pedersen
Claude Bonde
Dorthe Kot Engelund
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Novo Nordisk A/S
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Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of SI1687019T1 publication Critical patent/SI1687019T1/sl

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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)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (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)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (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. PROPILEN GLIKOL-KI VSEBUJE PEPTIDNE FORMULACIJE, KI SO OPTIMALNE ZA PROIZVODNJO IN ZA UPORABO V INJEKCIJSKIH NAPRAVAH PATENTNI ZAHTEVKI
    1. Farmacevtska formulacija, ki obsega peptid Arg34, Lys26(N£-(Y-Glu(Na-heksadekanoil)))-GLP-1(7-37) in propilen glikol, kjer je naveden propilen glikol prisoten v navedeni formulaciji v končni koncentraciji od 1 mg/ml do 100 mg/ml in kjer ima navedena formulacija pH od 7,0 do 10,0.
  2. 2. Formulacija po zahtevku 1, kjer je omenjena formulacija primerna za parenteralno dajanje s subkutano, intramuskularno ali intravensko injekcijo s pomočjo brizge, po izbiri peresu-podobne brizge (ang.«pen-like syringe«).
  3. 3. Formulacija po katerem koli od prejšnjih zahtevkov, kjer je koncentracija propilen glikola od 1 mg/ml do 50 mg/ml.
  4. 4. Formulacija po katerem koli od prejšnjih zahtevkov, kjer je koncentracija propilen glikola od 5 mg/ml do 25 mg/ml.
  5. 5. Formulacija po katerem koli od prejšnjih zahtevkov, kjer je koncentracija propilen glikola od 8 mg/ml do 16 mg/ml.
  6. 6. Formulacija po katerem koli izmed predhodnih zahtevkov, kjer je pH omenjene formulacije 7,0 do 9,5.
  7. 7. Formulacija po katerem koli od predhodnih zahtevkov, kjer omenjeni peptid sestoji iz Arg34, Lys26 (N£-(Y-Glu(NQ-heksadekanoil)))-GLP-1(7-37).
  8. 8. Formulacija po zahtevku 7, kjer je pH omenjene formulacije 7,0 do 8,3.
  9. 9. Formulacija po zahtevku 8, kjer je pH omenjene formulacije 7,3 do 8,3.
  10. 10. Formulacija po zahtevku 9, kjer je pH omenjene formulacije 8,0 do 8,3.
  11. 11. Formulacija po katerem koli od predhodnih zahtevkov, ki nadalje obsega konzervans.
  12. 12. Formulacija po zahtevku 11, kjer je omenjeni konzervans prisoten v koncentraciji od 0,1 mg/ml do 20 mg/ml.
  13. 13. Formulacija po zahtevku 11 ali 12, kjer je omenjeni konzervans fenol.
  14. 14. Formulacija po katerem koli od predhodnih zahtevkov, ki nadalje obsega pufer.
  15. 15. Formulacija po zahtevku 14, kjer je navedeni pufer izbran iz skupine, ki jo sestavljajo glicilglicin, natrijev dihidrogen fosfat, dinatrijev hidrogen fosfat, natrijev fosfat ali njihove zmesi.
  16. 16. Formulacija po zahtevkih 14, pri čemer je navedeni pufer dinatrijev fosfat dihidrat.
  17. 17. Formulacija po katerem koli od prejšnjih zahtevkov, kjer je koncentracija omenjenega Arg34, Lys26(N-£-(Y-Glu(N-a-heksadekanoil)))-GLP-1(7-37) od 0,1 mg/ml do 50 mg/ml ali od 0,1 mg/ml do 10 mg/m.
SI200432419T 2003-11-20 2004-11-18 Propilen gliko-ki vsebuje peptidne formulacije, ki so optimalne za proizvodnjo in za uporabo v injekcijskih napravah SI1687019T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DKPA200301719 2003-11-20
EP04797453.0A EP1687019B1 (en) 2003-11-20 2004-11-18 Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
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
SI1687019T1 true SI1687019T1 (sl) 2018-04-30

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ID=34609967

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SI200432419T SI1687019T1 (sl) 2003-11-20 2004-11-18 Propilen gliko-ki vsebuje peptidne formulacije, ki so optimalne za proizvodnjo in za uporabo v injekcijskih napravah
SI200432469T SI3300721T1 (sl) 2003-11-20 2004-11-18 Peptidne formulacije, ki vsebujejo propilen glikol in ki so optimalne za proizvodnjo in uporabo v napravah za injiciranje

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SI200432469T SI3300721T1 (sl) 2003-11-20 2004-11-18 Peptidne formulacije, ki vsebujejo propilen glikol in ki so optimalne za proizvodnjo in uporabo v napravah za injiciranje

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Country Link
US (5) US8114833B2 (sl)
EP (3) EP1687019B1 (sl)
JP (2) JP5558655B2 (sl)
KR (1) KR101243648B1 (sl)
CN (4) CN104826116A (sl)
AU (1) AU2004290862B2 (sl)
BR (1) BRPI0416743A (sl)
CA (1) CA2545034C (sl)
CY (1) CY1119723T1 (sl)
DK (2) DK3300721T3 (sl)
ES (2) ES2727854T3 (sl)
HK (1) HK1246683B (sl)
HU (2) HUE038395T2 (sl)
MX (1) MXPA06005581A (sl)
PL (2) PL1687019T3 (sl)
PT (2) PT3300721T (sl)
RU (1) RU2421238C2 (sl)
SI (2) SI1687019T1 (sl)
TR (1) TR201906789T4 (sl)
WO (1) WO2005049061A2 (sl)

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