HRP20201969T1 - Pripravci inzulina namijenjeni brzom unosu - Google Patents

Pripravci inzulina namijenjeni brzom unosu Download PDF

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Publication number
HRP20201969T1
HRP20201969T1 HRP20201969TT HRP20201969T HRP20201969T1 HR P20201969 T1 HRP20201969 T1 HR P20201969T1 HR P20201969T T HRP20201969T T HR P20201969TT HR P20201969 T HRP20201969 T HR P20201969T HR P20201969 T1 HRP20201969 T1 HR P20201969T1
Authority
HR
Croatia
Prior art keywords
insulin
formulation according
acid
formulation
chelator
Prior art date
Application number
HRP20201969TT
Other languages
English (en)
Inventor
Solomon S. Steiner
Roderike Pohl
Ming Li
Robert Hauser
Original Assignee
Eli Lilly And Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42238758&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20201969(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Eli Lilly And Company filed Critical Eli Lilly And Company
Publication of HRP20201969T1 publication Critical patent/HRP20201969T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/03Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/62Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy

Landscapes

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

Claims (9)

1. Formulacija inzulina, naznačena time što sadrži inzulin, sredstvo za otapanje, te kelator za cink, gdje je sredstvo za otapanje natrijev citrat ili limunska kiselina, a kelator za cink se bira između etilendiamintetraoctene kiseline (EDTA), EGTA, trinatrijevog citrata (TSC), alginske kiseline, α-lipoinske kiseline, dimerkaptojantarne kiseline (DMSA), te CDTA (1,2-diaminocikloheksantetraoctena kiselina), gdje formulacija ima pH od otprilike 7,4, te je bistra vodena otopina.
2. Formulacija u skladu s patentnim zahtjevom 1, naznačena time što je sredstvo za otapanje limunska kiselina.
3. Formulacija u skladu s patentnim zahtjevom 1, naznačena time što je sredstvo za otapanje natrijev citrat.
4. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time što je kelator za cink etilendiamintetraoctena kiselina (EDTA).
5. Formulacija u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time što je kelator za cink trinatrijev citrat (TSC).
6. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što se inzulin bira između ljudskog inzulina, analoga inzulina i njihovih kombinacija.
7. Formulacija u skladu s patentnim zahtjevom 6, naznačena time što je inzulin rekombinantni ljudski inzulin.
8. Formulacija u skladu s patentnim zahtjevom 6, naznačena time što je inzulin analog inzulina.
9. Formulacija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je formulacija bistra vodena otopina na 4 °C.
HRP20201969TT 2009-03-03 2020-12-08 Pripravci inzulina namijenjeni brzom unosu HRP20201969T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/397,219 US9060927B2 (en) 2009-03-03 2009-03-03 Insulin formulations for rapid uptake
EP18155633.3A EP3372238B1 (en) 2009-03-03 2010-03-03 Insulin formulations for rapid uptake

Publications (1)

Publication Number Publication Date
HRP20201969T1 true HRP20201969T1 (hr) 2021-02-05

Family

ID=42238758

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20181035TT HRP20181035T1 (hr) 2009-03-03 2018-07-05 Formulacije inzulina za brzi unos
HRP20201969TT HRP20201969T1 (hr) 2009-03-03 2020-12-08 Pripravci inzulina namijenjeni brzom unosu

Family Applications Before (1)

Application Number Title Priority Date Filing Date
HRP20181035TT HRP20181035T1 (hr) 2009-03-03 2018-07-05 Formulacije inzulina za brzi unos

Country Status (24)

Country Link
US (1) US9060927B2 (hr)
EP (3) EP2403520B1 (hr)
JP (1) JP5794736B2 (hr)
KR (1) KR20120006991A (hr)
CN (1) CN102341119A (hr)
AU (1) AU2010221397B2 (hr)
BR (1) BRPI1012642A2 (hr)
CA (1) CA2754251C (hr)
CY (2) CY1120583T1 (hr)
DK (2) DK3372238T3 (hr)
ES (2) ES2845177T3 (hr)
HR (2) HRP20181035T1 (hr)
HU (1) HUE039333T2 (hr)
IL (1) IL214699A (hr)
LT (2) LT2403520T (hr)
MX (1) MX2011009174A (hr)
NZ (1) NZ595445A (hr)
PL (1) PL2403520T3 (hr)
PT (1) PT2403520T (hr)
RU (1) RU2506945C2 (hr)
SG (1) SG173858A1 (hr)
SI (2) SI2403520T1 (hr)
TR (1) TR201809817T4 (hr)
WO (1) WO2010102020A1 (hr)

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