MX2012006541A - Composicion de la hormona del crecimiento seca enlazada transitoriamente a un portador del polimero. - Google Patents

Composicion de la hormona del crecimiento seca enlazada transitoriamente a un portador del polimero.

Info

Publication number
MX2012006541A
MX2012006541A MX2012006541A MX2012006541A MX2012006541A MX 2012006541 A MX2012006541 A MX 2012006541A MX 2012006541 A MX2012006541 A MX 2012006541A MX 2012006541 A MX2012006541 A MX 2012006541A MX 2012006541 A MX2012006541 A MX 2012006541A
Authority
MX
Mexico
Prior art keywords
growth hormone
polymer carrier
hormone composition
dry growth
transiently linked
Prior art date
Application number
MX2012006541A
Other languages
English (en)
Other versions
MX337432B (es
Inventor
Harald Rau
Thomas Wegge
Grethe Noerskov Rasmussen
Susanne Kindermann
Original Assignee
Ascendis Pharma As
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 Ascendis Pharma As filed Critical Ascendis Pharma As
Publication of MX2012006541A publication Critical patent/MX2012006541A/es
Publication of MX337432B publication Critical patent/MX337432B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/56Medicinal 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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal 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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal 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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/19Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La presente invención se refiere a composiciones secas del profármaco del polímero de rhGH que contienen un lioprotector y, opcionalmente, uno o más de un excipiente. Tales composiciones son estables durante al menos 1 año, cuando se almacenan a 2-8 °C. La invención se refiere además a los métodos de fabricación de las composiciones, a los recipientes que comprenden tal composición así como a un kit de partes.
MX2012006541A 2009-12-15 2010-12-15 Composicion de la hormona del crecimiento seca enlazada transitoriamente a un portador del polimero. MX337432B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09179335 2009-12-15
PCT/EP2010/069710 WO2011073234A2 (en) 2009-12-15 2010-12-15 Growth hormone composition

Publications (2)

Publication Number Publication Date
MX2012006541A true MX2012006541A (es) 2012-07-10
MX337432B MX337432B (es) 2016-03-04

Family

ID=41682273

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2012006541A MX337432B (es) 2009-12-15 2010-12-15 Composicion de la hormona del crecimiento seca enlazada transitoriamente a un portador del polimero.

Country Status (19)

Country Link
US (4) US9511122B2 (es)
EP (1) EP2512450B1 (es)
JP (1) JP2013513647A (es)
CN (2) CN102711733A (es)
AU (1) AU2010332958B2 (es)
BR (1) BR112012014721B1 (es)
CA (1) CA2783296C (es)
DK (1) DK2512450T3 (es)
ES (1) ES2667025T3 (es)
HK (1) HK1214948A1 (es)
HU (1) HUE038405T2 (es)
IL (1) IL219981A (es)
LT (1) LT2512450T (es)
MX (1) MX337432B (es)
RU (1) RU2012129674A (es)
SG (1) SG181648A1 (es)
SI (1) SI2512450T1 (es)
WO (1) WO2011073234A2 (es)
ZA (1) ZA201204334B (es)

Families Citing this family (11)

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ES2587400T3 (es) * 2008-04-29 2016-10-24 Ascendis Pharma Growth Disorders Division A/S Compuestos de hormona de crecimiento humana recombinante pegilada
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
TW201605468A (zh) 2013-09-27 2016-02-16 韓美藥品股份有限公司 長效人類生長激素接合物之製劑
KR102608645B1 (ko) * 2014-11-18 2023-12-01 아센디스 파마 엔도크리놀로지 디비전 에이/에스 신규한 중합체성 hGH 프로드러그
EP3220892B1 (en) 2014-11-21 2021-10-13 Ascendis Pharma Endocrinology Division A/S Long-acting growth hormone dosage forms
JP7059195B2 (ja) * 2016-03-01 2022-04-25 アセンディス ファーマ ボーン ディジージズ エー/エス Pthプロドラッグ
KR20230170810A (ko) 2016-09-29 2023-12-19 아센디스 파마 본 디지즈 에이/에스 낮은 피크 대 트로프 비를 가진 pth 화합물
KR20240013849A (ko) 2016-09-29 2024-01-30 아센디스 파마 본 디지즈 에이/에스 조절 방출 pth 화합물을 위한 투여 용법
SG11202007524QA (en) * 2018-03-28 2020-09-29 Ascendis Pharma Oncology Div A/S Il-2 conjugates
US20210196568A1 (en) * 2018-05-21 2021-07-01 Chugai Seiyaku Kabushiki Kaisha Lyophilized formulation sealed in glass container
AU2021286177A1 (en) 2020-06-03 2022-12-01 Ascendis Pharma Oncology Division A/S IL-2 sequences and uses thereof

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Also Published As

Publication number Publication date
BR112012014721B1 (pt) 2022-06-28
US20180185452A1 (en) 2018-07-05
EP2512450A2 (en) 2012-10-24
ZA201204334B (en) 2013-02-27
CN102711733A (zh) 2012-10-03
AU2010332958A1 (en) 2012-06-14
IL219981A0 (en) 2012-07-31
SG181648A1 (en) 2012-07-30
AU2010332958B2 (en) 2014-09-18
LT2512450T (lt) 2018-04-25
US20170056477A1 (en) 2017-03-02
DK2512450T3 (en) 2018-04-23
US10682395B2 (en) 2020-06-16
US20200261544A1 (en) 2020-08-20
US9919033B2 (en) 2018-03-20
US9511122B2 (en) 2016-12-06
SI2512450T1 (en) 2018-05-31
ES2667025T3 (es) 2018-05-09
WO2011073234A9 (en) 2012-06-07
US20120322721A1 (en) 2012-12-20
CN105125508A (zh) 2015-12-09
WO2011073234A3 (en) 2012-04-19
WO2011073234A2 (en) 2011-06-23
IL219981A (en) 2017-04-30
RU2012129674A (ru) 2014-01-27
MX337432B (es) 2016-03-04
CA2783296A1 (en) 2011-06-23
BR112012014721A2 (pt) 2017-03-14
HK1214948A1 (zh) 2016-08-12
EP2512450B1 (en) 2018-02-07
CA2783296C (en) 2019-01-15
JP2013513647A (ja) 2013-04-22
HUE038405T2 (hu) 2018-10-29

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