MX2016003705A - Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada. - Google Patents

Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada.

Info

Publication number
MX2016003705A
MX2016003705A MX2016003705A MX2016003705A MX2016003705A MX 2016003705 A MX2016003705 A MX 2016003705A MX 2016003705 A MX2016003705 A MX 2016003705A MX 2016003705 A MX2016003705 A MX 2016003705A MX 2016003705 A MX2016003705 A MX 2016003705A
Authority
MX
Mexico
Prior art keywords
growth hormone
human growth
type human
preparation
sustained type
Prior art date
Application number
MX2016003705A
Other languages
English (en)
Inventor
Sung Min Bae
Se Chang Kwon
Hyung Kyu Lim
Hyun Uk Kim
Sang Yun Kim
Hwa Peoung Rim
Ho Taek Im
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 MX2016003705A publication Critical patent/MX2016003705A/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
    • A61K47/06—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
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/6835—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 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6883—Polymer-drug antibody conjugates, e.g. mitomycin-dextran-Ab; DNA-polylysine-antibody complex or conjugate used for therapy
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • 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
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH

Landscapes

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

Abstract

La presente invención se refiere a una preparación de conjugado de hormona del crecimiento humana de tipo sostenido que comprende: un conjugado de la hormona del crecimiento humana (hGH) de tipo sostenido resultante de la conjugación entre la región Fc de inmunoglobulina y una hormona del crecimiento humana (hGH) que constituye un péptido bioactivo; una solución tampón; un tensioactivo no iónico; y un alcohol de azúcar. Más específicamente, la presente invención se refiere a una preparación liofilizada sostenida de conjugado de hormona del crecimiento de tipo humano y una preparación líquida, a un método de producción para la preparación liofilizada, a un método de reconstitución de la preparación liofilizada y a un kit que comprende la preparación liofilizada y a una solución de reconstitución.
MX2016003705A 2013-09-27 2014-09-26 Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada. MX2016003705A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20130115177 2013-09-27
PCT/KR2014/009059 WO2015046974A1 (ko) 2013-09-27 2014-09-26 지속형 인간 성장 호르몬 제제

Publications (1)

Publication Number Publication Date
MX2016003705A true MX2016003705A (es) 2016-05-16

Family

ID=52743982

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016003705A MX2016003705A (es) 2013-09-27 2014-09-26 Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada.

Country Status (15)

Country Link
US (2) US10987425B2 (es)
EP (2) EP3050559B1 (es)
JP (1) JP6549104B2 (es)
KR (1) KR102276304B1 (es)
CN (2) CN114288254A (es)
AR (1) AR097840A1 (es)
AU (1) AU2014329003A1 (es)
BR (1) BR112016006455A2 (es)
CA (1) CA2925416A1 (es)
HK (1) HK1225976A1 (es)
IL (1) IL244769A0 (es)
MX (1) MX2016003705A (es)
RU (1) RU2683823C2 (es)
TW (1) TW201605468A (es)
WO (1) WO2015046974A1 (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20130049671A (ko) 2011-11-04 2013-05-14 한미사이언스 주식회사 생리활성 폴리펩타이드 결합체 제조 방법
AR090281A1 (es) 2012-03-08 2014-10-29 Hanmi Science Co Ltd Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo
CA2944138C (en) * 2014-03-31 2023-06-20 Hanmi Pharm. Co., Ltd. Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage
KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
KR20170079409A (ko) * 2015-12-30 2017-07-10 한미약품 주식회사 지속형 인간 성장 호르몬 결합체의 신규 액상 제제
CN106256835A (zh) * 2016-08-19 2016-12-28 安源医药科技（上海）有限公司 高糖基化人生长激素融合蛋白及其制备方法与用途
KR101861163B1 (ko) 2017-04-26 2018-05-25 삼천당제약주식회사 안과용 약학 조성물
MX2022014669A (es) * 2020-05-22 2023-02-13 Hanmi Pharm Ind Co Ltd Formulacion liquida de conjugado de derivado de glucagon de accion prolongada.
CN115845032A (zh) * 2022-10-28 2023-03-28 深圳科兴药业有限公司 生长激素fc融合蛋白注射液及其用途

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
FR2719479B1 (fr) * 1994-05-04 1996-07-26 Sanofi Elf Formulation stable lyophilisée comprenant une protéine: kit de dosage.
US6096871A (en) 1995-04-14 2000-08-01 Genentech, Inc. Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life
ZA966075B (en) 1995-07-27 1998-01-19 Genentech Inc Protein formulation.
JPH10265404A (ja) 1996-02-02 1998-10-06 Mitsui Chem Inc ヒト成長ホルモンを含有する医薬製剤
AUPN801296A0 (en) * 1996-02-12 1996-03-07 Csl Limited Stabilised growth hormone formulation and method of preparation thereof
CA2249195A1 (en) 1996-03-18 1997-09-25 Board Of Regents, The University Of Texas System Immunoglobin-like domains with increased half lives
US20020077461A1 (en) * 1996-04-24 2002-06-20 Soren Bjorn Pharmaceutical formulation
US20070179096A1 (en) 1996-04-24 2007-08-02 Novo Nordisk A/S Pharmaceutical Formulation
SE9704405D0 (sv) 1997-11-28 1997-11-28 Pharmacia & Upjohn Ab New syringe
RU2190129C2 (ru) 2000-10-17 2002-09-27 Открытое акционерное общество "Павловский машиностроительный завод "Восход" Резервированный электрогидравлический привод
ES2338218T3 (es) * 2001-07-25 2010-05-05 Facet Biotech Corporation Formulacion farmacologica liofilizada estable de anticuerpos igg daclizumab.
US20050176108A1 (en) 2003-03-13 2005-08-11 Young-Min Kim Physiologically active polypeptide conjugate having prolonged in vivo half-life
PT2256134E (pt) 2003-11-13 2014-03-05 Hanmi Science Co Ltd Fragmento fc de igg para um veículo de fármaco e método para a preparação do mesmo
JP4845741B2 (ja) * 2003-12-23 2011-12-28 ファルマシア コーポレーション 安定な成長ホルモン液体製剤
SG161209A1 (en) * 2004-12-22 2010-05-27 Ambrx Inc Formulations of human growth hormone comprising a non-naturally encoded amino acid
JP4283776B2 (ja) 2005-03-07 2009-06-24 ラボラトワール セローノ ソシエテ アノニム Ｈｇｈ含有医薬組成物
KR100754667B1 (ko) 2005-04-08 2007-09-03 한미약품 주식회사 비펩타이드성 중합체로 개질된 면역글로불린 Ｆｃ 단편 및이를 포함하는 약제학적 조성물
CA2915270C (en) * 2005-08-05 2017-07-11 Amgen Inc. Stable aqueous protein or antibody pharmaceutical formulations and their preparation
MX2008015132A (es) * 2006-05-30 2008-12-10 Genentech Inc Anticuerpos e inmunoconjugados y sus usos.
CN102711733A (zh) * 2009-12-15 2012-10-03 阿森迪斯药物股份有限公司 瞬时连接于聚合物载体的干生长激素组合物
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
EP2606908A1 (en) * 2011-12-19 2013-06-26 Ipsen Pharma S.A.S. Novel pharmaceutical composition for a long acting growth hormone fusion protein (LAGH)
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate

Also Published As

Publication number Publication date
BR112016006455A2 (pt) 2017-08-01
CA2925416A1 (en) 2015-04-02
WO2015046974A1 (ko) 2015-04-02
JP6549104B2 (ja) 2019-07-24
IL244769A0 (en) 2016-04-21
TW201605468A (zh) 2016-02-16
EP3050559A4 (en) 2017-05-31
HK1225976A1 (zh) 2017-09-22
RU2016113684A3 (es) 2018-06-28
EP3050559A1 (en) 2016-08-03
EP3050559B1 (en) 2020-06-03
KR20150035681A (ko) 2015-04-07
CN105848645A (zh) 2016-08-10
US20160213789A1 (en) 2016-07-28
CN114288254A (zh) 2022-04-08
US20210138070A1 (en) 2021-05-13
KR102276304B1 (ko) 2021-07-14
AR097840A1 (es) 2016-04-20
US10987425B2 (en) 2021-04-27
EP3689335A1 (en) 2020-08-05
JP2016533345A (ja) 2016-10-27
RU2016113684A (ru) 2017-11-01
RU2683823C2 (ru) 2019-04-02
AU2014329003A1 (en) 2016-05-12

Similar Documents

Publication Publication Date Title
MX2016003705A (es) Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada.
AU2017279583B2 (en) Liquid Formulation Of Protein Conjugate Comprising The Oxyntomodulin And An Immunoglobulin Fragment
NZ719036A (en) Anti-pdl1 antibody formulations
PH12014502778A1 (en) Antibody formulation
EA201890817A1 (ru) Кристаллические формы бета-никотинамида мононуклеотида
PH12016501937A1 (en) Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage
MX2018005194A (es) Proteinas de fusion fgf21 de accion prolongada y composicion farmacuetica que comprende las mismas.
MY170720A (en) Antibody formulations
AR092216A1 (es) Formulaciones estables de anticuerpos contra tslp
AR082257A1 (es) Composicion de inmunoglobulinas humanas concentradas, procedimiento
WO2014178078A3 (en) Novel cloning, expression & purification method for the preparation of ranibizumab
PH12016502430A1 (en) Method for decreasing immunogenicity of protein and peptide
MX366622B (es) Composicion farmaceutica estable de la proteina de fusion tnfr:fc.
TW201613631A (en) Ghrelin secretion promoter
MX2020006586A (es) Metodos para potenciar la eliminacion de impurezas durante una cromatografia con proteina a.
PH12016500403A1 (en) An anti serum albumin fab-effector moiety fusion construct, and the preparing method thereof
MY166380A (en) Process for purifying recombinant plasmodium falciparum circumsporozoite protein
AR090583A1 (es) Formulacion liquida de conjugados de la hormona de crecimiento humana de accion prolongada, altamente concentrada
WO2014152831A3 (en) Targeting peptides and uses thereof
MX2013012259A (es) Analogos del factor de liberacion de la hormona de crecimiento (grf) y usos de estos.
WO2012168680A8 (en) Pharmaceutical preparation comprising recombinant fsh
IN2015MN00102A (es)
UA88870U (uk) Білковий крем