AR107276A1 - Una formulación líquida de conjugado de hormona del crecimiento humana de acción prolongada - Google Patents

Una formulación líquida de conjugado de hormona del crecimiento humana de acción prolongada

Info

Publication number
AR107276A1
AR107276A1 ARP160104091A ARP160104091A AR107276A1 AR 107276 A1 AR107276 A1 AR 107276A1 AR P160104091 A ARP160104091 A AR P160104091A AR P160104091 A ARP160104091 A AR P160104091A AR 107276 A1 AR107276 A1 AR 107276A1
Authority
AR
Argentina
Prior art keywords
human
liquid formulation
conjugate
hgh
prolonged action
Prior art date
Application number
ARP160104091A
Other languages
English (en)
Inventor
Se Chang Kwon
Sung Min Bae
Joo Young Dong
Hyung Kyu Lim
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 AR107276A1 publication Critical patent/AR107276A1/es

Links

Classifications

    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1796—Receptors; Cell surface antigens; Cell surface determinants for hormones
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1774—Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • 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
    • 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
    • A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Endocrinology (AREA)
  • Cell Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)

Abstract

Reivindicación 1: Una formulación líquida de un conjugado de hormona del crecimiento humana (hGH) de acción prolongada que comprende: (i) un conjugado de hGH de acción prolongada en el que la hGH está unida a una región Fc de inmunoglobulina; y (ii) un estabilizante exento de albúmina que comprende una solución tampón, un alcohol de azúcar, un tensioactivo no iónico y un conservante, sin un agente isotónico. Reivindicación 24: Un procedimiento de preparación de la formulación de la reivindicación 1, que comprende mezclar un conjugado de hGH de acción prolongada, en el que el conjugado de hGH está unido a la región Fc de inmunoglobulina, con un tampón, un alcohol de azúcar, un tensioactivo no iónico y un conservante.
ARP160104091A 2015-12-30 2016-12-30 Una formulación líquida de conjugado de hormona del crecimiento humana de acción prolongada AR107276A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020150189919A KR20170079409A (ko) 2015-12-30 2015-12-30 지속형 인간 성장 호르몬 결합체의 신규 액상 제제

Publications (1)

Publication Number Publication Date
AR107276A1 true AR107276A1 (es) 2018-04-11

Family

ID=59227383

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP160104091A AR107276A1 (es) 2015-12-30 2016-12-30 Una formulación líquida de conjugado de hormona del crecimiento humana de acción prolongada

Country Status (15)

Country Link
US (1) US20190022183A1 (es)
EP (1) EP3398586A4 (es)
JP (1) JP2019500390A (es)
KR (1) KR20170079409A (es)
CN (1) CN108697642A (es)
AR (1) AR107276A1 (es)
AU (1) AU2016382383A1 (es)
BR (1) BR112018013535A2 (es)
CA (1) CA3009627A1 (es)
HK (1) HK1258240A1 (es)
IL (1) IL260316A (es)
MX (1) MX2018008026A (es)
RU (1) RU2018125963A (es)
TW (1) TW201735940A (es)
WO (1) WO2017116191A2 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220054586A1 (en) * 2018-09-10 2022-02-24 Samsung Bioepis Co., Ltd. Liquid composition comprising protein
KR20220095204A (ko) * 2019-10-30 2022-07-06 제이씨알 파마 가부시키가이샤 혈청 알부민과 성장 호르몬의 융합 단백질을 함유하는 수성 의약 조성물

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU5103200A (en) * 1999-05-31 2000-12-18 Mitsubishi Chemical Corporation Freeze dried hgf preparations
ATE522548T1 (de) * 2003-11-13 2011-09-15 Hanmi Holdings Co Ltd Verfahren zur massenproduktion der konstanten region von immunglobulin
KR20100103846A (ko) * 2007-12-21 2010-09-28 메르크 파텐트 게엠베하 내부 고체 코어 내에 성장 호르몬을 함유하는 고체 지질 마이크로캡슐
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
WO2015046974A1 (ko) * 2013-09-27 2015-04-02 한미약품 주식회사 지속형 인간 성장 호르몬 제제

Also Published As

Publication number Publication date
IL260316A (en) 2019-02-28
WO2017116191A3 (ko) 2018-03-08
AU2016382383A1 (en) 2018-07-26
CA3009627A1 (en) 2017-07-06
EP3398586A4 (en) 2019-08-07
CN108697642A (zh) 2018-10-23
HK1258240A1 (zh) 2019-11-08
RU2018125963A (ru) 2020-01-30
MX2018008026A (es) 2018-11-29
TW201735940A (zh) 2017-10-16
BR112018013535A2 (pt) 2018-12-04
KR20170079409A (ko) 2017-07-10
US20190022183A1 (en) 2019-01-24
JP2019500390A (ja) 2019-01-10
EP3398586A2 (en) 2018-11-07
WO2017116191A2 (ko) 2017-07-06

Similar Documents

Publication Publication Date Title
AR113034A2 (es) Formulación líquida de un conjugado de la hormona del crecimiento humano de efecto prolongado
AR091902A1 (es) Formulacion liquida de un conjugado de insulina de accion prolongada
GT201700096A (es) Formulación estable de proteína en solución que contiene una alta concentración de un anticuerpo anti-vegf
AR094821A1 (es) Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
GT201400285A (es) Formulacion de anticuerpos
AR111455A1 (es) Formulación estable de anticuerpo
CO7111300A2 (es) Formulación de anticuerpos
EA201890945A1 (ru) Биологические препараты и их применение в отношении растений
AR108936A2 (es) Formulación subcutánea de anticuerpo anti-her2
AR092862A1 (es) Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
BR112016029906A8 (pt) formulação líquida, uso de formulação terapêutica líquida, uso de formulação terapêutica líquida injetável, método de melhoria da estabilidade de uma formulação proteica líquida e método de melhoria de um processo relacionado a proteínas
PE20170900A1 (es) Metodos y formulaciones para tratar enfermedades vasculares de los ojos
AR107014A1 (es) Formulación farmacéutica acuosa
PH12015502441A1 (en) Anti-il-4/anti-il-13 bispecific antibody formulations
AU2014318696B2 (en) Liquid protein formulations containing organophosphates
JOP20180125B1 (ar) صيغة صيدلانية سائلة ثابتة
MX2017007178A (es) Formulaciones liquidas estables de virus de vacuna.
PE20170301A1 (es) Medios y metodos para el tratamiento cmv
AR090583A1 (es) Formulacion liquida de conjugados de la hormona de crecimiento humana de accion prolongada, altamente concentrada
AR107276A1 (es) Una formulación líquida de conjugado de hormona del crecimiento humana de acción prolongada
AR094874A1 (es) Formulaciones para el tratamiento de semillas
CL2017000974A1 (es) Limoneno: formulación y uso insecticida
AR123425A1 (es) Una composición agroquímica líquida
AR104371A1 (es) Procedimiento para la preparación de una composición que comprende fibras proteicas
MY190160A (en) Skin disinfectant composition

Legal Events

Date Code Title Description
FB Suspension of granting procedure