BR112012014721A2 - composição de hormônio do crescimento - Google Patents

composição de hormônio do crescimento

Info

Publication number
BR112012014721A2
BR112012014721A2 BR112012014721A BR112012014721A BR112012014721A2 BR 112012014721 A2 BR112012014721 A2 BR 112012014721A2 BR 112012014721 A BR112012014721 A BR 112012014721A BR 112012014721 A BR112012014721 A BR 112012014721A BR 112012014721 A2 BR112012014721 A2 BR 112012014721A2
Authority
BR
Brazil
Prior art keywords
growth hormone
hormone composition
composition
compositions
relates
Prior art date
Application number
BR112012014721A
Other languages
English (en)
Other versions
BR112012014721B1 (pt
Inventor
Norskov Rasmussen Grethe
Rau Harald
Kindermann Susanne
Wegge Thomas
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 BR112012014721A2 publication Critical patent/BR112012014721A2/pt
Publication of BR112012014721B1 publication Critical patent/BR112012014721B1/pt

Links

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
    • A61K38/22—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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/08—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
    • 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
    • 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
    • A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 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
    • A61K47/60—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 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
    • 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
    • A61K9/08—Solutions
    • 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
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes 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)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Anesthesiology (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

patente de invenção: composição de hormônio do crescimento. a presente invenção refere-se a composições anidras de profármaco polimérico de rhgh, contendo um lioprotetor e, opcionalmente, um ou mais excipientes. tais composições são estáveis por pelo menos 1 ano, quando estocadas a 2-8° c. a invenção refere-se ainda a métodos para fabricar as ditas composições, recipientes que compreendem essa composição, bem como um kit de partes.
BR112012014721-8A 2009-12-15 2010-12-15 Composições de hormônio do crescimento, seus métodos de fabricação, recipiente e kit BR112012014721B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09179335 2009-12-15
EP09179335.6 2009-12-15
PCT/EP2010/069710 WO2011073234A2 (en) 2009-12-15 2010-12-15 Growth hormone composition

Publications (2)

Publication Number Publication Date
BR112012014721A2 true BR112012014721A2 (pt) 2017-03-14
BR112012014721B1 BR112012014721B1 (pt) 2022-06-28

Family

ID=41682273

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012014721-8A BR112012014721B1 (pt) 2009-12-15 2010-12-15 Composições de hormônio do crescimento, seus métodos de fabricação, recipiente e kit

Country Status (19)

Country Link
US (4) US9511122B2 (pt)
EP (1) EP2512450B1 (pt)
JP (1) JP2013513647A (pt)
CN (2) CN105125508A (pt)
AU (1) AU2010332958B2 (pt)
BR (1) BR112012014721B1 (pt)
CA (1) CA2783296C (pt)
DK (1) DK2512450T3 (pt)
ES (1) ES2667025T3 (pt)
HK (1) HK1214948A1 (pt)
HU (1) HUE038405T2 (pt)
IL (1) IL219981A (pt)
LT (1) LT2512450T (pt)
MX (1) MX337432B (pt)
RU (1) RU2012129674A (pt)
SG (1) SG181648A1 (pt)
SI (1) SI2512450T1 (pt)
WO (1) WO2011073234A2 (pt)
ZA (1) ZA201204334B (pt)

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CA2925416A1 (en) * 2013-09-27 2015-04-02 Hanmi Pharm. Co., Ltd. Sustained type human growth hormone preparation
IL307773A (en) * 2014-11-18 2023-12-01 Ascendis Pharma Endocrinology Div A/S Novel polymeric human growth hormone drug matrices
WO2016079302A1 (en) * 2014-11-21 2016-05-26 Ascendis Pharma Growth Disorders Division A/S Long-acting growth hormone dosage forms
KR20180100624A (ko) 2016-01-08 2018-09-11 아센디스 파마 그로우쓰 디스오더스 에이/에스 증가된 nep 안정성을 갖는 제어 방출성 cnp 작용제
CN115025239A (zh) * 2016-03-01 2022-09-09 阿森迪斯药物骨疾病股份有限公司 Pth前药
WO2018060310A1 (en) 2016-09-29 2018-04-05 Ascendis Pharma Bone Diseases A/S Dosage regimen for a controlled-release pth compound
ES2943720T3 (es) 2016-09-29 2023-06-15 Ascendis Pharma Bone Diseases As Compuestos de PTH con bajas relaciones de pico a valle
MX2020009857A (es) * 2018-03-28 2021-01-08 Ascendis Pharma Oncology Div A/S Conjugados de interleucina-2 (il-2).
TWI840360B (zh) * 2018-05-21 2024-05-01 日商中外製藥股份有限公司 密封於玻璃容器之凍結乾燥的製劑、套組、製造凍結乾燥製劑的方法、防止或減低凍結乾燥製劑的玻璃容器成霧的方法、及容器內面經過硫酸銨處理或ｖｉｓｔ處理之玻璃容器
BR112022022826A2 (pt) 2020-06-03 2022-12-13 Ascendis Pharma Oncology Div A/S Sequências de il-2 e usos das mesmas

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Also Published As

Publication number Publication date
CA2783296C (en) 2019-01-15
AU2010332958A1 (en) 2012-06-14
US20200261544A1 (en) 2020-08-20
LT2512450T (lt) 2018-04-25
WO2011073234A2 (en) 2011-06-23
DK2512450T3 (en) 2018-04-23
IL219981A (en) 2017-04-30
US9919033B2 (en) 2018-03-20
BR112012014721B1 (pt) 2022-06-28
IL219981A0 (en) 2012-07-31
HK1214948A1 (zh) 2016-08-12
MX337432B (es) 2016-03-04
AU2010332958B2 (en) 2014-09-18
WO2011073234A3 (en) 2012-04-19
JP2013513647A (ja) 2013-04-22
US20170056477A1 (en) 2017-03-02
ZA201204334B (en) 2013-02-27
CN105125508A (zh) 2015-12-09
US20120322721A1 (en) 2012-12-20
US20180185452A1 (en) 2018-07-05
ES2667025T3 (es) 2018-05-09
SI2512450T1 (en) 2018-05-31
US9511122B2 (en) 2016-12-06
MX2012006541A (es) 2012-07-10
SG181648A1 (en) 2012-07-30
HUE038405T2 (hu) 2018-10-29
CA2783296A1 (en) 2011-06-23
US10682395B2 (en) 2020-06-16
CN102711733A (zh) 2012-10-03
EP2512450B1 (en) 2018-02-07
EP2512450A2 (en) 2012-10-24
RU2012129674A (ru) 2014-01-27
WO2011073234A9 (en) 2012-06-07

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Owner name: ASCENDIS PHARMA GROWTH DISORDERS DIVISION A/S (DK)

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Ipc: A61K 38/27 (2006.01), A61K 9/00 (2006.01), A61K 9/

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Ipc: A61K 9/14 (2006.01), A61K 9/19 (2006.01), A61K 38/

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B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
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