AR091902A1 - Formulacion liquida de un conjugado de insulina de accion prolongada - Google Patents

Formulacion liquida de un conjugado de insulina de accion prolongada

Info

Publication number
AR091902A1
AR091902A1 ARP130102651A ARP130102651A AR091902A1 AR 091902 A1 AR091902 A1 AR 091902A1 AR P130102651 A ARP130102651 A AR P130102651A AR P130102651 A ARP130102651 A AR P130102651A AR 091902 A1 AR091902 A1 AR 091902A1
Authority
AR
Argentina
Prior art keywords
insulin conjugate
liquid formulation
formulation
long
prolonged insulin
Prior art date
Application number
ARP130102651A
Other languages
English (en)
Inventor
Uk Kim Hyun
Young Kim Min
Hee Hong Sung
Kyu Lim Hyung
Original Assignee
Hanmi Pharm Ind 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 Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of AR091902A1 publication Critical patent/AR091902A1/es

Links

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
    • 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
    • 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
    • A61K47/02—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
    • A61K47/50—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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (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)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Obesity (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

Una formulación líquida de un conjugado de insulina de acción prolongada que comprende una cantidad farmacéuticamente eficaz de un conjugado de insulina de acción prolongada, en el cual un péptido fisiológicamente activo, que es una insulina, se encuentra unido a la región Fc de una inmunoglobulina, y comprende además un estabilizador libre de albúmina que comprende una solución amortiguadora, un alcohol de azúcar, un tensioactivo no iónico, y un agente isotónico. Método para preparar la formulación. Además, para impedir la contaminación microbiana en múltiples usos, se puede agregar un conservante a la formulación.
ARP130102651A 2012-07-25 2013-07-24 Formulacion liquida de un conjugado de insulina de accion prolongada AR091902A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR20120081477 2012-07-25

Publications (1)

Publication Number Publication Date
AR091902A1 true AR091902A1 (es) 2015-03-11

Family

ID=49997581

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP130102651A AR091902A1 (es) 2012-07-25 2013-07-24 Formulacion liquida de un conjugado de insulina de accion prolongada

Country Status (20)

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

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AR091902A1 (es) 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
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AR091902A1 (es) 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada

Also Published As

Publication number Publication date
TWI605824B (zh) 2017-11-21
PL2877157T3 (pl) 2019-06-28
AU2013293718A1 (en) 2015-02-12
DK2877157T3 (en) 2019-03-25
CA2879976C (en) 2023-03-07
TW201412328A (zh) 2014-04-01
JP6385925B2 (ja) 2018-09-05
PT2877157T (pt) 2019-03-22
KR20140015207A (ko) 2014-02-06
BR112015001457B1 (pt) 2023-02-28
CY1121356T1 (el) 2020-05-29
KR102088856B1 (ko) 2020-03-13
EP2877157A4 (en) 2016-06-01
HK1207816A1 (en) 2016-02-12
JP2015524428A (ja) 2015-08-24
JP6682570B2 (ja) 2020-04-15
US20150196643A1 (en) 2015-07-16
US10987424B2 (en) 2021-04-27
CA2879976A1 (en) 2014-01-30
BR112015001457A8 (pt) 2018-01-23
ES2715326T3 (es) 2019-06-03
CN104519871B (zh) 2018-07-20
RU2670270C2 (ru) 2018-10-22
MX369201B (es) 2019-10-30
JP2018119005A (ja) 2018-08-02
AU2013293718B2 (en) 2018-05-10
MX2015000988A (es) 2015-11-13
CN104519871A (zh) 2015-04-15
TR201903661T4 (tr) 2019-04-22
BR112015001457A2 (pt) 2017-07-04
EP2877157A1 (en) 2015-06-03
RU2015104495A (ru) 2016-09-10
TW201803587A (zh) 2018-02-01
WO2014017847A1 (en) 2014-01-30
HUE042246T2 (hu) 2019-06-28
EP2877157B1 (en) 2018-12-12

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