AR097840A1 - Una formulación de un conjugado de la hormona de crecimiento humana de la actividad prolongada, procedimiento, kit - Google Patents

Una formulación de un conjugado de la hormona de crecimiento humana de la actividad prolongada, procedimiento, kit

Info

Publication number
AR097840A1
AR097840A1 ARP140103607A ARP140103607A AR097840A1 AR 097840 A1 AR097840 A1 AR 097840A1 AR P140103607 A ARP140103607 A AR P140103607A AR P140103607 A ARP140103607 A AR P140103607A AR 097840 A1 AR097840 A1 AR 097840A1
Authority
AR
Argentina
Prior art keywords
growth hormone
human growth
formulation
long
conjugate
Prior art date
Application number
ARP140103607A
Other languages
English (en)
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 AR097840A1 publication Critical patent/AR097840A1/es

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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] (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

Abstract

Reivindicación 1: Una formulación de un conjugado de hormona de crecimiento humana de acción prolongada (hGH), que comprende un conjugado de hormona de crecimiento humana de acción prolongada (hGH), en que la hormona de crecimiento humana fisiológicamente activa (hGH) se une a una región Fc de inmunoglobulina, un tampón, un tensioactivo no iónico y un alcohol de azúcar. Reivindicación 2: La formulación de un conjugado de hormona de crecimiento humana de acción prolongada de acuerdo con la reivindicación 1, en la que la formulación es una formulación liofilizada de un conjugado de hormona de crecimiento humana de acción prolongada, que comprende una mezcla liofilizada de una solución acuosa que comprende un conjugado de hormona de crecimiento humana de acción prolongada (hGH) en que la hGH fisiológicamente activa se une a una región Fc de inmunoglobulina y una solución libre de albúmina que comprende un tampón, un tensioactivo no iónico y un alcohol de azúcar. Reivindicación 12: La formulación de un conjugado de hormona de crecimiento humana de acción prolongada de acuerdo con la reivindicación 2, en la que la solución libre de albúmina también comprende al menos uno seleccionado del grupo que consiste en un azúcar, un alcohol polihídrico y un aminoácido. Reivindicación 13: La formulación de un conjugado de hormona de crecimiento humana de acción prolongada de acuerdo con la reivindicación 12, en la que el aminoácido es histidina o glicina. Reivindicación 32: La formulación de un conjugado de hormona de crecimiento humana de acción prolongada de acuerdo con la reivindicación 1, 2 ó 20, en la que la región Fc de inmunoglobulina es una región Fc derivada de IgG, IgA, lgD, lgE o lgM. Reivindicación 36: La formulación de un conjugado de hormona de crecimiento humana de acción prolongada de acuerdo con la reivindicación 32, en la que la región Fc de inmunoglobulina es una región Fc de IgG4 humana aglicosilada.
ARP140103607A 2013-09-27 2014-09-29 Una formulación de un conjugado de la hormona de crecimiento humana de la actividad prolongada, procedimiento, kit AR097840A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR20130115177 2013-09-27

Publications (1)

Publication Number Publication Date
AR097840A1 true AR097840A1 (es) 2016-04-20

Family

ID=52743982

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP140103607A AR097840A1 (es) 2013-09-27 2014-09-29 Una formulación de un conjugado de la hormona de crecimiento humana de la actividad prolongada, procedimiento, kit

Country Status (15)

Country Link
US (2) US10987425B2 (es)
EP (2) EP3050559B1 (es)
JP (1) JP6549104B2 (es)
KR (1) KR102276304B1 (es)
CN (2) CN105848645A (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 (8)

* Cited by examiner, † Cited by third party
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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
EP3889185A3 (en) * 2014-03-31 2022-01-26 Hanmi Pharm. Co., Ltd. Composition for improving the solubility of a protein or 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.

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Also Published As

Publication number Publication date
CA2925416A1 (en) 2015-04-02
MX2016003705A (es) 2016-05-16
EP3050559B1 (en) 2020-06-03
CN114288254A (zh) 2022-04-08
HK1225976A1 (zh) 2017-09-22
EP3050559A1 (en) 2016-08-03
WO2015046974A1 (ko) 2015-04-02
RU2683823C2 (ru) 2019-04-02
EP3050559A4 (en) 2017-05-31
KR20150035681A (ko) 2015-04-07
BR112016006455A2 (pt) 2017-08-01
RU2016113684A3 (es) 2018-06-28
AU2014329003A1 (en) 2016-05-12
US10987425B2 (en) 2021-04-27
RU2016113684A (ru) 2017-11-01
KR102276304B1 (ko) 2021-07-14
US20160213789A1 (en) 2016-07-28
TW201605468A (zh) 2016-02-16
JP6549104B2 (ja) 2019-07-24
EP3689335A1 (en) 2020-08-05
US20210138070A1 (en) 2021-05-13
IL244769A0 (en) 2016-04-21
JP2016533345A (ja) 2016-10-27
CN105848645A (zh) 2016-08-10

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