JP6084036B2 - ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物 - Google Patents

ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物 Download PDF

Info

Publication number
JP6084036B2
JP6084036B2 JP2012539223A JP2012539223A JP6084036B2 JP 6084036 B2 JP6084036 B2 JP 6084036B2 JP 2012539223 A JP2012539223 A JP 2012539223A JP 2012539223 A JP2012539223 A JP 2012539223A JP 6084036 B2 JP6084036 B2 JP 6084036B2
Authority
JP
Japan
Prior art keywords
solution
buffer
igf
pharmaceutical composition
concentration
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
JP2012539223A
Other languages
English (en)
Japanese (ja)
Other versions
JP2013510893A (ja
Inventor
イーノナ・ゴピナス
スーザン・パーク
力 荒川
力 荒川
ジョエル・リシャール
ファビオ・ファイス
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ipsen Pharma SAS
Original Assignee
Ipsen Pharma SAS
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 Ipsen Pharma SAS filed Critical Ipsen Pharma SAS
Publication of JP2013510893A publication Critical patent/JP2013510893A/ja
Application granted granted Critical
Publication of JP6084036B2 publication Critical patent/JP6084036B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • A61K47/16—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
    • 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
    • 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
    • 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
    • A61K38/30—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2012539223A 2009-11-17 2010-11-17 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物 Expired - Fee Related JP6084036B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US26185909P 2009-11-17 2009-11-17
US61/261,859 2009-11-17
PCT/EP2010/006996 WO2011060922A1 (en) 2009-11-17 2010-11-17 Formulation for hgh and rhigf-1 combination

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2015215192A Division JP6143827B2 (ja) 2009-11-17 2015-10-30 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物

Publications (2)

Publication Number Publication Date
JP2013510893A JP2013510893A (ja) 2013-03-28
JP6084036B2 true JP6084036B2 (ja) 2017-02-22

Family

ID=43661042

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2012539223A Expired - Fee Related JP6084036B2 (ja) 2009-11-17 2010-11-17 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物
JP2015215192A Expired - Fee Related JP6143827B2 (ja) 2009-11-17 2015-10-30 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2015215192A Expired - Fee Related JP6143827B2 (ja) 2009-11-17 2015-10-30 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物

Country Status (14)

Country Link
US (2) US20120270782A1 (cg-RX-API-DMAC10.html)
EP (1) EP2501367B1 (cg-RX-API-DMAC10.html)
JP (2) JP6084036B2 (cg-RX-API-DMAC10.html)
KR (1) KR101614983B1 (cg-RX-API-DMAC10.html)
CN (1) CN102665691B (cg-RX-API-DMAC10.html)
AU (1) AU2010321225B2 (cg-RX-API-DMAC10.html)
BR (1) BR112012011539A8 (cg-RX-API-DMAC10.html)
CA (1) CA2780554C (cg-RX-API-DMAC10.html)
ES (1) ES2532007T3 (cg-RX-API-DMAC10.html)
IN (1) IN2012DN02861A (cg-RX-API-DMAC10.html)
MX (1) MX2012005195A (cg-RX-API-DMAC10.html)
RU (1) RU2558821C2 (cg-RX-API-DMAC10.html)
UA (1) UA108994C2 (cg-RX-API-DMAC10.html)
WO (1) WO2011060922A1 (cg-RX-API-DMAC10.html)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8158582B2 (en) 2005-06-02 2012-04-17 Tercica, Inc. Methods for treatment of insulin-like growth factor-1 deficiency
WO2013014196A1 (en) * 2011-07-25 2013-01-31 Sandoz Ag Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein
US9216219B2 (en) 2012-06-12 2015-12-22 Novartis Ag Anti-BAFFR antibody formulation
CN104371019B (zh) 2013-08-13 2019-09-10 鸿运华宁（杭州）生物医药有限公司 一种能与glp-1r特异性结合的抗体及其与glp-1的融合蛋白质
ES2964713T3 (es) * 2014-10-23 2024-04-09 Amgen Inc Reducción de la viscosidad de formulaciones farmacéuticas
WO2016115561A1 (en) * 2015-01-18 2016-07-21 Biogen Ma Inc. Formulations and screening of biological therapeutic agents
EP3257524B1 (en) * 2015-02-11 2020-08-26 Gmax Biopharm LLC Stabilized solution preparation of pharmaceutical glp-1r antibody fusion protein
ES2962373T3 (es) * 2016-04-13 2024-03-18 Medimmune Llc Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas
WO2018034867A1 (en) * 2016-08-15 2018-02-22 The University Of North Carolina At Chapel Hill Tardigrade disordered proteins as protein stabilizers
JP7275027B2 (ja) 2016-10-06 2023-05-17 アムジェン インコーポレイテッド 粘度低下タンパク質医薬製剤
US10953074B2 (en) * 2017-01-08 2021-03-23 Richard D. Lippman Composition and method for improving sensorineural hearing
JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
EP3681602B1 (en) 2017-09-11 2026-04-15 Oak Hill Bio Limited Compositions for reducing the incidence of bpd
CA3176341A1 (en) * 2020-04-22 2021-10-28 Zyon AYNI Pharmaceutical compositions and anti-viral uses thereof
KR20230113287A (ko) * 2020-10-19 2023-07-28 오크 힐 바이오 리미티드 신생아에 사용하기에 적합한 조성물
IL305132A (en) * 2021-02-12 2023-10-01 Neuren Pharmaceuticals Ltd Preparations for the treatment of the Prader-Willi phenomenon
MX2024006318A (es) * 2021-11-26 2024-08-14 Genexine Inc Formulacion para administracion de alta concentracion de proteina de fusion de hormona del crecimiento.

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL71991A (en) 1983-06-06 1994-05-30 Genentech Inc Preparation of human FGI and FGE in their processed form through recombinant AND tranology in prokaryotes
US5763394A (en) * 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
US5374620A (en) * 1990-06-07 1994-12-20 Genentech, Inc. Growth-promoting composition and its use
US5126324A (en) 1990-06-07 1992-06-30 Genentech, Inc. Method of enhancing growth in patients using combination therapy
US5681814A (en) * 1990-06-07 1997-10-28 Genentech, Inc. Formulated IGF-I Composition
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
DK0955062T3 (da) * 1992-07-31 2007-09-17 Genentech Inc Vandig formulering indeholdende humant væksthormon
US6207640B1 (en) * 1994-04-07 2001-03-27 Genentech, Inc. Treatment of partial growth hormone insensitivity syndrome
JPH10511964A (ja) * 1995-01-13 1998-11-17 ノボ ノルディスク アクティーゼルスカブ 成長ホルモン及びＸ−Ｌｙｓを含む安定化医薬製剤
US6767892B1 (en) * 1997-11-07 2004-07-27 Chrion Corporation Compositions providing for increased IGF-I solubility
JP2001522813A (ja) * 1997-11-07 2001-11-20 カイロン コーポレイション 新規のｉｇｆ−ｉ組成物およびその使用
CN1360506A (zh) * 1999-07-12 2002-07-24 格兰迪斯生物技术有限公司 生长激素配方
CZ305123B6 (cs) * 1999-10-04 2015-05-13 Novartis Vaccines And Diagnostics, Inc. Způsob výroby kapalného farmaceutického prostředku
CA2476934C (en) * 2002-02-27 2009-06-16 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
AU2003249992A1 (en) * 2002-07-09 2004-01-23 Sandoz Ag Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
US8158582B2 (en) * 2005-06-02 2012-04-17 Tercica, Inc. Methods for treatment of insulin-like growth factor-1 deficiency
US20070135343A1 (en) * 2005-11-01 2007-06-14 Wyeth Sodium chloride solution for drug reconstitution or dilution
LT2049148T (lt) * 2006-07-06 2016-11-25 Daewoong Co., Ltd. Žmogaus augimo hormono skysta stabili kompozicija
CN102089319B (zh) * 2008-05-08 2013-11-13 味之素株式会社 蛋白质的重折叠方法

Also Published As

Publication number Publication date
CN102665691A (zh) 2012-09-12
UA108994C2 (uk) 2015-07-10
IN2012DN02861A (cg-RX-API-DMAC10.html) 2015-07-24
US20120270782A1 (en) 2012-10-25
BR112012011539A2 (pt) 2016-06-28
CA2780554C (en) 2017-08-15
HK1175711A1 (en) 2013-07-12
KR101614983B1 (ko) 2016-04-22
US20170143834A1 (en) 2017-05-25
JP2016020395A (ja) 2016-02-04
MX2012005195A (es) 2012-06-12
EP2501367B1 (en) 2015-01-21
EP2501367A1 (en) 2012-09-26
CA2780554A1 (en) 2011-05-26
RU2558821C2 (ru) 2015-08-10
JP2013510893A (ja) 2013-03-28
CN102665691B (zh) 2015-05-27
KR20120104251A (ko) 2012-09-20
AU2010321225B2 (en) 2015-12-03
WO2011060922A1 (en) 2011-05-26
JP6143827B2 (ja) 2017-06-07
AU2010321225A1 (en) 2012-06-07
BR112012011539A8 (pt) 2017-12-26
ES2532007T3 (es) 2015-03-23
RU2012124985A (ru) 2013-12-27

Similar Documents

Publication Publication Date Title
JP6143827B2 (ja) ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物
CN1273187C (zh) 稳定性提高的无锌或低锌胰岛素制剂
CN104994864B (zh) 包含人胰岛素或其类似物或衍生物的稳定水性组合物
RU2467762C2 (ru) Составы паратиреоидного гормона и их применение
JP4255515B2 (ja) 安定化された成長ホルモン処方物およびその製造方法
JP7738046B2 (ja) 組換えヒト副甲状腺ホルモンの安定性を向上させるための製剤
AU2013368990B2 (en) Pharmaceutical composition
US10052361B2 (en) Liquid pharmaceutical composition of conjugated erythropoietin
HK1175711B (en) Formulation for hgh and rhigf-1 combination
JP2001522814A (ja) 増大されたｉｇｆ−ｉ溶解性を提供する組成物
HK1061521B (en) Insulin preparations, which do not contain any zinc or only a small quantity of zinc and which have an improved stability
BR112015011179B1 (pt) Composições farmacêuticas aquosas estáveis compreendendo insulina humana ou um análogo ou derivado das mesmas, seu uso e processos para sua preparação

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20131003

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20140916

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20141215

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20150630

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20151030

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20151111

A912 Re-examination (zenchi) completed and case transferred to appeal board

Free format text: JAPANESE INTERMEDIATE CODE: A912

Effective date: 20151211

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20161208

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20170124

R150 Certificate of patent or registration of utility model

Ref document number: 6084036

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

LAPS Cancellation because of no payment of annual fees