CY1121356T1 - Υγρο σκευασμα συζυγους ινσουλινης μακρας δρασης - Google Patents

Υγρο σκευασμα συζυγους ινσουλινης μακρας δρασης

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Publication number
CY1121356T1
CY1121356T1 CY20191100288T CY191100288T CY1121356T1 CY 1121356 T1 CY1121356 T1 CY 1121356T1 CY 20191100288 T CY20191100288 T CY 20191100288T CY 191100288 T CY191100288 T CY 191100288T CY 1121356 T1 CY1121356 T1 CY 1121356T1
Authority
CY
Cyprus
Prior art keywords
formulation
insulin
long
sponsive
liquid preparation
Prior art date
Application number
CY20191100288T
Other languages
English (en)
Inventor
Hyung Kyu Lim
Hyun Uk Kim
Sung Hee Hong
Min Young Kim
Sung Min Bae
Se Chang Kwon
Original Assignee
Hanmi Pharm. Co., Ltd
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
Application filed by Hanmi Pharm. Co., Ltd filed Critical Hanmi Pharm. Co., Ltd
Publication of CY1121356T1 publication Critical patent/CY1121356T1/el

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Classifications

    • 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
    • A61K9/08—Solutions
    • 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
    • A61K47/10—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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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
    • 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

Landscapes

  • 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)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Η παρούσα εφεύρεση αφορά σε ένα υγρό σκεύασμα συζυγούς ινσουλίνης μακράς δράσης, το οποίο περιλαμβάνει μια αποτελεσματική από φαρμακευτική άποψη ποσότητα ενός συζυγούς ινσουλίνης μακράς δράσης, όπου ένα φυσιολογικά δραστικό πεπτίδιο, το οποίο είναι μια ινσουλίνη, συνδέεται με μια περιοχή Fc ανοσοσφαιρίνης, καθώς και έναν χωρίς λευκωματίνη σταθεροποιητή, όπου ο σταθεροποιητής περιλαμβάνει ρυθμιστικό, σακχαρούχο αλκοόλη, μη ιοντικό τασιενεργό και ισοτονικό παράγοντα, καθώς και σε μια μέθοδο για παρασκευή του σκευάσματος. Για πρόληψη της μικροβιακής μόλυνσης σε πολλαπλές χρήσεις, στο σκεύασμα μπορεί να προστίθεται ένα συντηρητικό. Το υγρό σκεύασμα της παρούσας εφεύρεσης δεν περιλαμβάνει λευκωματίνη ανθρώπινου ορού και δυνητικά επικίνδυνους παράγοντες για το σώμα και επομένως έχει άριστη σταθερότητα αποθήκευσης για το συζυγές ινσουλίνης, χωρίς κίνδυνο ιογενούς μόλυνσης.
CY20191100288T 2012-07-25 2019-03-12 Υγρο σκευασμα συζυγους ινσουλινης μακρας δρασης CY1121356T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20120081477 2012-07-25
PCT/KR2013/006673 WO2014017847A1 (en) 2012-07-25 2013-07-25 A liquid formulation of long-acting insulin conjugate

Publications (1)

Publication Number Publication Date
CY1121356T1 true CY1121356T1 (el) 2020-05-29

Family

ID=49997581

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20191100288T CY1121356T1 (el) 2012-07-25 2019-03-12 Υγρο σκευασμα συζυγους ινσουλινης μακρας δρασης

Country Status (21)

Country Link
US (1) US10987424B2 (el)
EP (1) EP2877157B1 (el)
JP (2) JP6385925B2 (el)
KR (1) KR102088856B1 (el)
CN (1) CN104519871B (el)
AR (1) AR091902A1 (el)
AU (1) AU2013293718B2 (el)
BR (1) BR112015001457B1 (el)
CA (1) CA2879976C (el)
CY (1) CY1121356T1 (el)
DK (1) DK2877157T3 (el)
ES (1) ES2715326T3 (el)
HK (1) HK1207816A1 (el)
HU (1) HUE042246T2 (el)
MX (1) MX369201B (el)
PL (1) PL2877157T3 (el)
PT (1) PT2877157T (el)
RU (1) RU2670270C2 (el)
TR (1) TR201903661T4 (el)
TW (2) TWI605824B (el)
WO (1) WO2014017847A1 (el)

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Also Published As

Publication number Publication date
RU2670270C2 (ru) 2018-10-22
CN104519871A (zh) 2015-04-15
MX369201B (es) 2019-10-30
US20150196643A1 (en) 2015-07-16
CA2879976A1 (en) 2014-01-30
BR112015001457A2 (pt) 2017-07-04
PL2877157T3 (pl) 2019-06-28
EP2877157B1 (en) 2018-12-12
AU2013293718B2 (en) 2018-05-10
WO2014017847A1 (en) 2014-01-30
JP2015524428A (ja) 2015-08-24
HUE042246T2 (hu) 2019-06-28
TR201903661T4 (tr) 2019-04-22
AR091902A1 (es) 2015-03-11
JP6385925B2 (ja) 2018-09-05
KR102088856B1 (ko) 2020-03-13
CA2879976C (en) 2023-03-07
DK2877157T3 (en) 2019-03-25
BR112015001457B1 (pt) 2023-02-28
JP6682570B2 (ja) 2020-04-15
PT2877157T (pt) 2019-03-22
AU2013293718A1 (en) 2015-02-12
US10987424B2 (en) 2021-04-27
CN104519871B (zh) 2018-07-20
JP2018119005A (ja) 2018-08-02
TWI605824B (zh) 2017-11-21
TW201412328A (zh) 2014-04-01
ES2715326T3 (es) 2019-06-03
MX2015000988A (es) 2015-11-13
RU2015104495A (ru) 2016-09-10
BR112015001457A8 (pt) 2018-01-23
HK1207816A1 (en) 2016-02-12
TW201803587A (zh) 2018-02-01
EP2877157A1 (en) 2015-06-03
EP2877157A4 (en) 2016-06-01
KR20140015207A (ko) 2014-02-06

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