AR040529A1 - Formulaciones de hgh en alta concentracion que contienen 1,2-propilenglicol - Google Patents

Formulaciones de hgh en alta concentracion que contienen 1,2-propilenglicol

Info

Publication number
AR040529A1
AR040529A1 AR20030102461A ARP030102461A AR040529A1 AR 040529 A1 AR040529 A1 AR 040529A1 AR 20030102461 A AR20030102461 A AR 20030102461A AR P030102461 A ARP030102461 A AR P030102461A AR 040529 A1 AR040529 A1 AR 040529A1
Authority
AR
Argentina
Prior art keywords
crystallization
propylene glycol
growth hormone
human growth
formulations
Prior art date
Application number
AR20030102461A
Other languages
English (en)
Original Assignee
Grandis Biotech Gmbh
Sandoz Ag
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=30119134&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR040529(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Grandis Biotech Gmbh, Sandoz Ag filed Critical Grandis Biotech Gmbh
Publication of AR040529A1 publication Critical patent/AR040529A1/es

Links

Classifications

    • 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
    • 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
    • A61K47/02—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
    • 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
    • A61K47/06—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Neurology (AREA)
  • Urology & Nephrology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente se refiere a formulaciones líquidas de hormona de crecimiento humano (hGH, somatrofina) que son estables durante el almacenamiento, presenta una cristalización reducida o ninguna cristalización durante el almacenamiento y son adecuadas para administrar a un ser humano o animal. Con mayor particularidad, se refiere a formulaciones líquidas de hormona de crecimiento humano que es estable y presenta una cristalización mínima o ninguna cristalización cuando son almacenadas al menos durante un tiempo a temperaturas de refrigeración. Reivindicación 1: Una formulación farmacéutica líquida multidosis que contiene esencialmente hormona de crecimiento humano en una concentración de alrededor de 5 mg/ml hasta alrededor de 100 mg/ml, 1,2-propilenglicol, un buffer acuoso, un agente tensioactivo no iónico y un conservante, en donde dicha formulación presenta una tonicidad de alrededor de 100 mosm/kg a alrededor de 500 mosm/kg, tiene un pH de alrededor de 6,1 hasta alrededor de 6,3 y está esencialmente libre de un excipiente aminoácido.
AR20030102461A 2002-07-09 2003-07-08 Formulaciones de hgh en alta concentracion que contienen 1,2-propilenglicol AR040529A1 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US39461102P 2002-07-09 2002-07-09
US39469902P 2002-07-09 2002-07-09
US39461202P 2002-07-09 2002-07-09

Publications (1)

Publication Number Publication Date
AR040529A1 true AR040529A1 (es) 2005-04-13

Family

ID=30119134

Family Applications (3)

Application Number Title Priority Date Filing Date
AR20030102459A AR040527A1 (es) 2002-07-09 2003-07-08 Formulaciones de hgh en alta concentracion que contienen glicina
AR20030102461A AR040529A1 (es) 2002-07-09 2003-07-08 Formulaciones de hgh en alta concentracion que contienen 1,2-propilenglicol
AR20030102458A AR040526A1 (es) 2002-07-09 2003-07-08 Formulaciuones de hgh en alta concentracion que contienen fenol

Family Applications Before (1)

Application Number Title Priority Date Filing Date
AR20030102459A AR040527A1 (es) 2002-07-09 2003-07-08 Formulaciones de hgh en alta concentracion que contienen glicina

Family Applications After (1)

Application Number Title Priority Date Filing Date
AR20030102458A AR040526A1 (es) 2002-07-09 2003-07-08 Formulaciuones de hgh en alta concentracion que contienen fenol

Country Status (9)

Country Link
US (2) US20060165733A1 (es)
EP (3) EP1521596A1 (es)
JP (3) JP2005535651A (es)
CN (3) CN100475267C (es)
AR (3) AR040527A1 (es)
AU (2) AU2003250915A1 (es)
CA (3) CA2491478A1 (es)
MX (3) MXPA05000414A (es)
WO (3) WO2004004781A1 (es)

Families Citing this family (27)

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EP1603588A2 (en) * 2003-03-18 2005-12-14 Ares Trading S.A. Stabilisation of growth hormones in solution
AU2005237775B2 (en) * 2004-04-07 2010-03-04 Ares Trading S.A. Liquid growth hormone formulation
CN101027318B (zh) 2004-07-19 2016-05-25 比奥孔有限公司 胰岛素-低聚物共轭物，制剂及其用途
CN101505789A (zh) * 2006-07-06 2009-08-12 株式会社大熊 稳定的人生长激素液体制剂
WO2009050738A2 (en) 2007-10-16 2009-04-23 Biocon Limited An orally administerable solid pharmaceutical composition and a process thereof
KR101614983B1 (ko) * 2009-11-17 2016-04-22 입센 파마 에스.에이.에스 Ｈｇｈ 및 ｒｈｉｇｆ―１의 조합물을 위한 제제
US8859626B2 (en) * 2010-03-08 2014-10-14 Case Western Reserve University Anti-virulence compositions and methods
BR112014001921B1 (pt) 2011-07-25 2022-05-10 Sandoz Ag Formulação aquosa farmaceuticamente aceitável, método para aumentar a estabilidade de uma formulação aquosa farmaceuticamente aceitável e embalagem principal
UA116217C2 (uk) 2012-10-09 2018-02-26 Санофі Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
CN104870009B (zh) 2012-12-21 2021-05-18 赛诺菲 官能化的毒蜥外泌肽-4衍生物
EP3080149A1 (en) 2013-12-13 2016-10-19 Sanofi Dual glp-1/glucagon receptor agonists
EP3080152A1 (en) 2013-12-13 2016-10-19 Sanofi Non-acylated exendin-4 peptide analogues
EP3080154B1 (en) 2013-12-13 2018-02-07 Sanofi Dual glp-1/gip receptor agonists
TW201609795A (zh) 2013-12-13 2016-03-16 賽諾菲公司 作為雙重ｇｌｐ－１／ｇｉｐ受體促效劑的艾塞那肽－４（ｅｘｅｎｄｉｎ－４）胜肽類似物
TW201625668A (zh) 2014-04-07 2016-07-16 賽諾菲公司 作為胜肽性雙重ｇｌｐ－１／昇糖素受體激動劑之艾塞那肽－４衍生物
TW201625670A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自ｅｘｅｎｄｉｎ－４之雙重ｇｌｐ－１／升糖素受體促效劑
TW201625669A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自艾塞那肽－４（Ｅｘｅｎｄｉｎ－４）之肽類雙重ＧＬＰ－１／升糖素受體促效劑
US9932381B2 (en) 2014-06-18 2018-04-03 Sanofi Exendin-4 derivatives as selective glucagon receptor agonists
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TW201706291A (zh) 2015-07-10 2017-02-16 賽諾菲公司 作為選擇性肽雙重ｇｌｐ－１／升糖素受體促效劑之新毒蜥外泌肽（ｅｘｅｎｄｉｎ－４）衍生物
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WO2017184880A1 (en) 2016-04-20 2017-10-26 Coherus Biosciences, Inc. A method of filling a container with no headspace
PE20211202A1 (es) 2017-08-24 2021-07-05 Novo Nordisk As Composiciones de glp-1 y sus usos
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WO2021144476A1 (en) 2020-02-18 2021-07-22 Novo Nordisk A/S Pharmaceutical formulations
CN115400076B (zh) * 2022-08-17 2023-09-05 安徽安科生物工程（集团）股份有限公司 重组人生长激素-Fc融合蛋白注射液制剂配方

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Also Published As

Publication number Publication date
AR040527A1 (es) 2005-04-13
MXPA05000413A (es) 2005-07-22
AU2003249991A1 (en) 2004-01-23
AR040526A1 (es) 2005-04-13
CN1665541A (zh) 2005-09-07
EP1521596A1 (en) 2005-04-13
CN1665540A (zh) 2005-09-07
JP2005535651A (ja) 2005-11-24
WO2004004779A8 (en) 2005-07-07
WO2004004780A1 (en) 2004-01-15
CN100475267C (zh) 2009-04-08
EP1521597A1 (en) 2005-04-13
WO2004004781A1 (en) 2004-01-15
MXPA05000412A (es) 2005-07-22
US20060165733A1 (en) 2006-07-27
AU2003250915A1 (en) 2004-01-23
AU2003249991B2 (en) 2007-01-25
EP1536835A1 (en) 2005-06-08
JP2005535652A (ja) 2005-11-24
CA2491478A1 (en) 2004-01-15
CN1668332A (zh) 2005-09-14
WO2004004779A1 (en) 2004-01-15
MXPA05000414A (es) 2005-07-22
CA2491682A1 (en) 2004-01-15
JP2005538068A (ja) 2005-12-15
CA2491685A1 (en) 2004-01-15
AU2003249992A1 (en) 2004-01-23
US20070014818A1 (en) 2007-01-18

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