MX369201B - Formulación líquida de un conjugado de insulina de acción prolongada. - Google Patents

Formulación líquida de un conjugado de insulina de acción prolongada.

Info

Publication number
MX369201B
MX369201B MX2015000988A MX2015000988A MX369201B MX 369201 B MX369201 B MX 369201B MX 2015000988 A MX2015000988 A MX 2015000988A MX 2015000988 A MX2015000988 A MX 2015000988A MX 369201 B MX369201 B MX 369201B
Authority
MX
Mexico
Prior art keywords
long
insulin conjugate
liquid formulation
acting insulin
formulation
Prior art date
Application number
MX2015000988A
Other languages
English (en)
Other versions
MX2015000988A (es
Inventor
Sung Min Bae
Se Chang Kwon
Min Young Kim
Hyung Kyu Lim
Hyun Uk Kim
Sung Hee Hong
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 MX2015000988A publication Critical patent/MX2015000988A/es
Publication of MX369201B publication Critical patent/MX369201B/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)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (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

La presente invención se refiere a 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 estabilizante 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. La formulación líquida de la presente invención no comprende una albúmina de suero humano y factores potencialmente peligrosos para el cuerpo, y por lo tanto tiene excelente estabilidad durante el almacenamiento del conjugado de insulina sin presentar riesgos de infección viral.
MX2015000988A 2012-07-25 2013-07-25 Formulación líquida de un conjugado de insulina de acción prolongada. MX369201B (es)

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 (2)

Publication Number Publication Date
MX2015000988A MX2015000988A (es) 2015-11-13
MX369201B true MX369201B (es) 2019-10-30

Family

ID=49997581

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015000988A MX369201B (es) 2012-07-25 2013-07-25 Formulación líquida de un conjugado de insulina de acción 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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Also Published As

Publication number Publication date
DK2877157T3 (en) 2019-03-25
EP2877157A1 (en) 2015-06-03
MX2015000988A (es) 2015-11-13
TW201803587A (zh) 2018-02-01
US10987424B2 (en) 2021-04-27
CN104519871A (zh) 2015-04-15
PL2877157T3 (pl) 2019-06-28
HUE042246T2 (hu) 2019-06-28
EP2877157B1 (en) 2018-12-12
BR112015001457A2 (pt) 2017-07-04
CY1121356T1 (el) 2020-05-29
AR091902A1 (es) 2015-03-11
JP6682570B2 (ja) 2020-04-15
CA2879976A1 (en) 2014-01-30
KR20140015207A (ko) 2014-02-06
CN104519871B (zh) 2018-07-20
RU2670270C2 (ru) 2018-10-22
ES2715326T3 (es) 2019-06-03
US20150196643A1 (en) 2015-07-16
BR112015001457B1 (pt) 2023-02-28
JP6385925B2 (ja) 2018-09-05
EP2877157A4 (en) 2016-06-01
PT2877157T (pt) 2019-03-22
AU2013293718A1 (en) 2015-02-12
TW201412328A (zh) 2014-04-01
TWI605824B (zh) 2017-11-21
WO2014017847A1 (en) 2014-01-30
JP2015524428A (ja) 2015-08-24
BR112015001457A8 (pt) 2018-01-23
JP2018119005A (ja) 2018-08-02
RU2015104495A (ru) 2016-09-10
AU2013293718B2 (en) 2018-05-10
TR201903661T4 (tr) 2019-04-22
CA2879976C (en) 2023-03-07
HK1207816A1 (en) 2016-02-12
KR102088856B1 (ko) 2020-03-13

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