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 prolongadaInfo
- 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
Links
- 239000012669 liquid formulation Substances 0.000 title abstract 2
- 230000002035 prolonged effect Effects 0.000 title 1
- 102000002265 Human Growth Hormone Human genes 0.000 abstract 6
- 108010000521 Human Growth Hormone Proteins 0.000 abstract 6
- 239000000854 Human Growth Hormone Substances 0.000 abstract 6
- 108060003951 Immunoglobulin Proteins 0.000 abstract 2
- 102000018358 immunoglobulin Human genes 0.000 abstract 2
- 239000002736 nonionic surfactant Substances 0.000 abstract 2
- 239000003755 preservative agent Substances 0.000 abstract 2
- 230000002335 preservative effect Effects 0.000 abstract 2
- 150000005846 sugar alcohols Chemical class 0.000 abstract 2
- 239000000872 buffer Substances 0.000 abstract 1
- 239000007853 buffer solution Substances 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000007951 isotonicity adjuster Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
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)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Peptides Or Proteins (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.
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)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2020055123A1 (ko) * | 2018-09-10 | 2020-03-19 | 삼성바이오에피스 주식회사 | 단백질을 포함하는 액상 조성물 |
US20220378882A1 (en) * | 2019-10-30 | 2022-12-01 | Jcr Pharmaceuticals Co., Ltd. | Aqueous pharmaceutical composition containing fusion protein of serum albumin and growth hormone |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1180368B1 (en) * | 1999-05-31 | 2007-04-18 | Mitsubishi Chemical Corporation | Freeze dried hgf preparations |
JP4870569B2 (ja) * | 2003-11-13 | 2012-02-08 | ハンミ ホールディングス カンパニー リミテッド | 免疫グロブリン断片を用いた蛋白質結合体およびその製造方法 |
JP5773651B2 (ja) * | 2007-12-21 | 2015-09-02 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツングMerck Patent Gesellschaft mit beschraenkter Haftung | 内部固形コア中に成長ホルモンを含有する固形脂質マイクロカプセル |
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 |
CN105848645A (zh) * | 2013-09-27 | 2016-08-10 | 韩美药品株式会社 | 持续型人生长激素制剂 |
-
2015
- 2015-12-30 KR KR1020150189919A patent/KR20170079409A/ko unknown
-
2016
- 2016-12-30 MX MX2018008026A patent/MX2018008026A/es unknown
- 2016-12-30 JP JP2018534559A patent/JP2019500390A/ja active Pending
- 2016-12-30 AR ARP160104091A patent/AR107276A1/es unknown
- 2016-12-30 BR BR112018013535-6A patent/BR112018013535A2/pt not_active Application Discontinuation
- 2016-12-30 WO PCT/KR2016/015534 patent/WO2017116191A2/ko active Application Filing
- 2016-12-30 TW TW105144163A patent/TW201735940A/zh unknown
- 2016-12-30 AU AU2016382383A patent/AU2016382383A1/en not_active Abandoned
- 2016-12-30 EP EP16882143.7A patent/EP3398586A4/en not_active Withdrawn
- 2016-12-30 RU RU2018125963A patent/RU2018125963A/ru not_active Application Discontinuation
- 2016-12-30 CA CA3009627A patent/CA3009627A1/en not_active Abandoned
- 2016-12-30 US US16/066,877 patent/US20190022183A1/en not_active Abandoned
- 2016-12-30 CN CN201680081848.9A patent/CN108697642A/zh active Pending
-
2018
- 2018-06-27 IL IL260316A patent/IL260316A/en unknown
-
2019
- 2019-01-14 HK HK19100601.0A patent/HK1258240A1/zh unknown
Also Published As
Publication number | Publication date |
---|---|
TW201735940A (zh) | 2017-10-16 |
WO2017116191A3 (ko) | 2018-03-08 |
CA3009627A1 (en) | 2017-07-06 |
KR20170079409A (ko) | 2017-07-10 |
AU2016382383A1 (en) | 2018-07-26 |
US20190022183A1 (en) | 2019-01-24 |
HK1258240A1 (zh) | 2019-11-08 |
BR112018013535A2 (pt) | 2018-12-04 |
CN108697642A (zh) | 2018-10-23 |
EP3398586A2 (en) | 2018-11-07 |
RU2018125963A (ru) | 2020-01-30 |
WO2017116191A2 (ko) | 2017-07-06 |
EP3398586A4 (en) | 2019-08-07 |
MX2018008026A (es) | 2018-11-29 |
IL260316A (en) | 2019-02-28 |
JP2019500390A (ja) | 2019-01-10 |
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