MX369479B - Formulación líquida de un cunjugado de péptido insulinotropico de acción prolongada. - Google Patents

Formulación líquida de un cunjugado de péptido insulinotropico de acción prolongada.

Info

Publication number
MX369479B
MX369479B MX2015001088A MX2015001088A MX369479B MX 369479 B MX369479 B MX 369479B MX 2015001088 A MX2015001088 A MX 2015001088A MX 2015001088 A MX2015001088 A MX 2015001088A MX 369479 B MX369479 B MX 369479B
Authority
MX
Mexico
Prior art keywords
insulinotropic peptide
liquid formulation
peptide conjugate
acting insulinotropic
long
Prior art date
Application number
MX2015001088A
Other languages
English (en)
Other versions
MX2015001088A (es
Inventor
Dae Jin Kim
Sung Min Bae
Se Chang Kwon
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 MX2015001088A publication Critical patent/MX2015001088A/es
Publication of MX369479B publication Critical patent/MX369479B/es

Links

Classifications

    • 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
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • 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
    • A61K47/26—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
    • 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
    • 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
    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (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)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente invención se refiere a una formulación líquida de conjugado de péptido insulinotrópico de acción prolongada, que comprende una cantidad farmacéuticamente eficaz del conjugado péptido insulinotrópico de acción prolongada que consiste en un péptido fisiológicamente activo, péptido insulinotrópico, y una región Fc de inmunoglobulina; y un estabilizador libre de albúmina, en donde el estabilizador comprende una solución amortiguadora, un alcohol de azúcar, un tensioactivo no iónico, y un agente isotónico, y un método para preparar la formulación. Para el propósito de prevenir la contaminación microbiana, se puede agregar un conservante. La formulación líquida de la presente invención está libre de albúmina sérica humana y otros factores potencialmente peligrosos para el cuerpo, sin tener riesgo de contaminación viral, y por consiguiente puede proveer una excelente estabilidad de almacenamiento para los conjugados de péptido insulinotrópico a alta concentración.
MX2015001088A 2012-07-25 2013-07-25 Formulación líquida de un cunjugado de péptido insulinotropico de acción prolongada. MX369479B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20120081476 2012-07-25
PCT/KR2013/006670 WO2014017845A2 (en) 2012-07-25 2013-07-25 A liquid formulation of long acting insulinotropic peptide conjugate

Publications (2)

Publication Number Publication Date
MX2015001088A MX2015001088A (es) 2015-07-06
MX369479B true MX369479B (es) 2019-11-08

Family

ID=49997928

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015001088A MX369479B (es) 2012-07-25 2013-07-25 Formulación líquida de un cunjugado de péptido insulinotropico de acción prolongada.

Country Status (16)

Country Link
US (1) US9801950B2 (es)
EP (1) EP2877158B1 (es)
JP (2) JP6385345B2 (es)
KR (1) KR102161177B1 (es)
CN (2) CN108125909A (es)
AR (1) AR094821A1 (es)
AU (1) AU2013293716B2 (es)
CA (1) CA2880026C (es)
ES (1) ES2759987T3 (es)
HK (1) HK1204565A1 (es)
MX (1) MX369479B (es)
PL (1) PL2877158T3 (es)
PT (1) PT2877158T (es)
RU (1) RU2671576C2 (es)
TW (1) TWI643637B (es)
WO (1) WO2014017845A2 (es)

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Also Published As

Publication number Publication date
AU2013293716B2 (en) 2018-04-26
RU2671576C2 (ru) 2018-11-02
TW201408337A (zh) 2014-03-01
KR102161177B1 (ko) 2020-09-29
CN108125909A (zh) 2018-06-08
RU2015104494A (ru) 2016-09-20
ES2759987T3 (es) 2020-05-12
JP6385345B2 (ja) 2018-09-05
JP6685343B2 (ja) 2020-04-22
MX2015001088A (es) 2015-07-06
EP2877158A4 (en) 2016-03-23
EP2877158A2 (en) 2015-06-03
AR094821A1 (es) 2015-09-02
CA2880026C (en) 2020-09-01
US20150238629A1 (en) 2015-08-27
PL2877158T3 (pl) 2020-04-30
JP2018119006A (ja) 2018-08-02
CA2880026A1 (en) 2014-01-30
CN104487053A (zh) 2015-04-01
EP2877158B1 (en) 2019-09-11
US9801950B2 (en) 2017-10-31
TWI643637B (zh) 2018-12-11
HK1204565A1 (en) 2015-11-27
CN104487053B (zh) 2018-01-30
KR20140018798A (ko) 2014-02-13
PT2877158T (pt) 2019-12-17
WO2014017845A3 (en) 2014-03-20
BR112015001735A2 (pt) 2021-04-13
AU2013293716A1 (en) 2015-02-19
WO2014017845A2 (en) 2014-01-30
JP2015522654A (ja) 2015-08-06

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