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

    • 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
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K38/26Glucagons
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/50Medicinal 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
    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

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

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 (21)

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)
HK (1) HK1207816A1 (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
RU2670270C2 (ru) 2018-10-22
CN104519871A (zh) 2015-04-15
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
CY1121356T1 (el) 2020-05-29
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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