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DK1629849T4 - Farmaceutiske sammensætninger omfattende exediner og agonister deraf - Google Patents

Farmaceutiske sammensætninger omfattende exediner og agonister deraf Download PDF

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Publication number
DK1629849T4
DK1629849T4 DK05011978.3T DK05011978T DK1629849T4 DK 1629849 T4 DK1629849 T4 DK 1629849T4 DK 05011978 T DK05011978 T DK 05011978T DK 1629849 T4 DK1629849 T4 DK 1629849T4
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Prior art keywords
exendin
composition
acid
vol
composition according
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DK05011978.3T
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English (en)
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DK1629849T3 (da
Inventor
Nigel Robert Arnold Beeley
Kathryn S Prickett
Sunil Amylin Pharmaceuticals Inc Bhavsar
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Amylin Pharmaceuticals Llc
Astrazeneca Pharmaceuticals Lp
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Application filed by Amylin Pharmaceuticals Llc, Astrazeneca Pharmaceuticals Lp filed Critical Amylin Pharmaceuticals Llc
Publication of DK1629849T3 publication Critical patent/DK1629849T3/da
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    • 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
    • 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
    • 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
    • A61K38/2207—Gastrins; Cholecystokinins [CCK]
    • 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
    • A61K38/2264—Obesity-gene products, e.g. leptin
    • 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
    • A61K38/23—Calcitonins
    • 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
    • A61K47/10—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
    • 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
    • A61K47/26—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
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • 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
    • A61P3/06—Antihyperlipidemics
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • C07K14/57563—Vasoactive intestinal peptide [VIP]; Related peptides
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Emergency Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Claims (9)

1. Farmaceutisk sammensætning til anvendelse i en fremgangsmåde til behandling af fedme eller type ll-diabetes, omfattende exendin-4 i en isotonisk pufferopløsning omfattende en natriumacetat-/eddikesyrepuffer, et isotonici-tetsmiddel i en vandig bærer, hvor sammensætningen har en pH-værdi på fra 3,5 til 5,0.
2. Sammensætning ifølge krav 1, isotonicitetsmidlet er valgt fra gruppen bestående af natriumchlorid, dextrose, borsyre, natriumtartrat, propylenglycol og polyoler.
3. Sammensætning ifølge et hvilket som helst af krav 1 eller 2, yderligere omfattende en farmaceutisk acceptabel bærer eller excipiens valgt fra gruppen bestående af calciumcarbonat, calciumphosphat, lactose, glucose, saccharose, stivelse, cellulosederivater, gelatine, vegetabilske olier og polyethy-lenglycol.
4. Sammensætning ifølge et hvilket som helst af krav 1 til 3, yderligere omfattende mindst ét yderligere stof valgt fra gruppen bestående af en amylin-agonist, en leptin eller en cholecystokinin (CCK).
5. Sammensætning ifølge et hvilket som helst af krav 1 til 3, yderligere omfattende 25-28'29pro humant amylin, CCK-8 eller laksecalcitonin.
6. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor sammensætningen er formuleret til at tilvejebringe en daglig dosis på fra 10 pg til 30 mg exendin-4 til en patient på 70 kg i en enkelt dosis eller delt dosis.
7. Sammensætning ifølge et hvilket som helst af de foregående krav, hvor sammensætningen er formuleret til intravenøs, intraperitoneal, subkutan, intramuskulær, oral, topisk, transmucosal eller pulmonal indgivelse.
8. Farmaceutisk sammensætning til anvendelse i en fremgangsmåde til behandling af fedme eller Type ll-diabetes omfattende exendin-4 i forbindelse med en farmaceutisk acceptabel bærer, hvor den farmaceutiske sammen sætning foreligger i enhedsdosisform, der er egnet til at levere fra 10 μg til 30 μg pr. dag exendin-4, eller et farmaceutisk acceptabelt salt deraf til en patient på 70 kg i enkeltdoser eller delte doser suspenderet i en isotonisk pufferopløsning omfattende en natriumacetat-/eddikesyrepuffer ved en pH-værdi på 3,5 til 5,0.
9. Farmaceutisk sammensætning til anvendelse i en fremgangsmåde til behandling af fedme eller Type ll-diabetes ifølge et hvilket som helst af krav 1 til 3, hvor et yderligere stof valgt fra gruppen bestående af amylinagonist, en leptin eller en cholecystokinin (CCK) indgives samtidigt eller særskilt.
DK05011978.3T 1997-01-07 1998-01-07 Farmaceutiske sammensætninger omfattende exediner og agonister deraf DK1629849T4 (da)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US3490597P 1997-01-07 1997-01-07
US5540497P 1997-08-08 1997-08-08
US6544297P 1997-11-14 1997-11-14
US6602997P 1997-11-14 1997-11-14
EP98904545A EP0996459B1 (en) 1997-01-07 1998-01-07 Use of exendins and agonists thereof for the reduction of food intake

Publications (2)

Publication Number Publication Date
DK1629849T3 DK1629849T3 (da) 2013-08-12
DK1629849T4 true DK1629849T4 (da) 2017-12-04

Family

ID=27488253

Family Applications (2)

Application Number Title Priority Date Filing Date
DK05011978.3T DK1629849T4 (da) 1997-01-07 1998-01-07 Farmaceutiske sammensætninger omfattende exediner og agonister deraf
DK98904545T DK0996459T3 (da) 1997-01-07 1998-01-07 Anvendelse af exendiner og agonister deraf til reduktion af födeindtagelse

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK98904545T DK0996459T3 (da) 1997-01-07 1998-01-07 Anvendelse af exendiner og agonister deraf til reduktion af födeindtagelse

Country Status (16)

Country Link
US (10) US6956026B2 (da)
EP (2) EP1629849B2 (da)
JP (1) JP4798814B2 (da)
AT (1) ATE304864T1 (da)
AU (1) AU739020B2 (da)
BE (1) BE2007C038I2 (da)
CA (1) CA2277112C (da)
DE (2) DE69831673C5 (da)
DK (2) DK1629849T4 (da)
ES (2) ES2247676T3 (da)
FR (1) FR07C0031I2 (da)
HK (1) HK1025252A1 (da)
LU (1) LU91342I2 (da)
NL (1) NL300281I2 (da)
PT (1) PT1629849E (da)
WO (1) WO1998030231A1 (da)

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US20050215469A1 (en) 2005-09-29
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US20030087821A1 (en) 2003-05-08
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