ES2181723T3 - Formulaciones farmaceuticas de factor de crecimiento nervioso. - Google Patents

Formulaciones farmaceuticas de factor de crecimiento nervioso.

Info

Publication number
ES2181723T3
ES2181723T3 ES94925903T ES94925903T ES2181723T3 ES 2181723 T3 ES2181723 T3 ES 2181723T3 ES 94925903 T ES94925903 T ES 94925903T ES 94925903 T ES94925903 T ES 94925903T ES 2181723 T3 ES2181723 T3 ES 2181723T3
Authority
ES
Spain
Prior art keywords
growth factor
pharmaceutical formulations
formulations
ngf
nervous growth
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 - Lifetime
Application number
ES94925903T
Other languages
English (en)
Inventor
Victoria M Knepp
Deborah M Lidgate
Richard Maskiewicz
Leo Gu
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.)
Syntex USA LLC
Original Assignee
Syntex USA LLC
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 Syntex USA LLC filed Critical Syntex USA LLC
Application granted granted Critical
Publication of ES2181723T3 publication Critical patent/ES2181723T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • A61K38/18—Growth factors; Growth regulators
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/185—Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61K47/12—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
    • A61K47/26—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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/827—Proteins from mammals or birds
    • Y10S530/839—Nerves; brain

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Psychology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

FORMULACIONES FARMACEUTICAS ACUOSAS ESTABLES DEL FACTOR DE CRECIMIENTO NERVIOSO HUMANO (NGF) EN SOLUCIONES ISOTONICAS ACUOSAS, SEPARADAS PARA MANTENER EL PH DE APROXIMADAMENTE 4.5 A 6.0, Y QUE CONTIENEN OPCIONALMENTE UN PORTADOR COMO UNA ALBUMINA DE SUERO HUMANO. TAMBIEN SE PROPORCIONAN FORMULACIONES NGF ACUOSAS UTILES PARA LA LIOFILIZACION Y RECONSTITUCION SUBSECUENTE EN LA QUE RHNGF ES MEZCLADO CON AZUCARES, OPCIONALMENTE HSA, Y UN SEPARADOR. LAS FORMULACIONES SON UTILES PARA EL TRATAMIENTO DE LA ENFERMEDAD DE ALZHEIMER Y OTROS TRASTORNOS NEUROLOGICOS.
ES94925903T 1993-08-20 1994-08-16 Formulaciones farmaceuticas de factor de crecimiento nervioso. Expired - Lifetime ES2181723T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US08/109,798 US6277828B1 (en) 1993-08-20 1993-08-20 Pharmaceutical formulations of nerve growth factor

Publications (1)

Publication Number Publication Date
ES2181723T3 true ES2181723T3 (es) 2003-03-01

Family

ID=22329623

Family Applications (1)

Application Number Title Priority Date Filing Date
ES94925903T Expired - Lifetime ES2181723T3 (es) 1993-08-20 1994-08-16 Formulaciones farmaceuticas de factor de crecimiento nervioso.

Country Status (32)

Country Link
US (2) US6277828B1 (es)
EP (1) EP0721343B1 (es)
JP (2) JP4592830B2 (es)
KR (1) KR100341193B1 (es)
CN (1) CN1163265C (es)
AT (1) ATE226085T1 (es)
AU (1) AU677699B2 (es)
BG (1) BG62951B1 (es)
BR (1) BR9407278A (es)
CA (1) CA2169834C (es)
CZ (1) CZ292422B6 (es)
DE (1) DE69431562T2 (es)
DK (1) DK0721343T3 (es)
ES (1) ES2181723T3 (es)
FI (1) FI113241B (es)
HK (1) HK1012990A1 (es)
HU (1) HU228152B1 (es)
IL (3) IL110725A (es)
LT (1) LT4051B (es)
LV (1) LV11279B (es)
NO (1) NO317627B1 (es)
NZ (1) NZ271873A (es)
PL (1) PL176387B1 (es)
PT (1) PT721343E (es)
RO (1) RO114742B1 (es)
RU (1) RU2126265C1 (es)
SI (1) SI9420048B (es)
SK (1) SK284064B6 (es)
TW (1) TW427905B (es)
UA (1) UA43348C2 (es)
WO (1) WO1995005845A1 (es)
ZA (1) ZA946333B (es)

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US5981485A (en) 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
AU721869B2 (en) * 1995-05-12 2000-07-13 Brigham And Women's Hospital Treatment of alzheimer disease by modulation of synapsins
US6964947B1 (en) 1995-11-07 2005-11-15 Genentech, Inc. Stabilizing formulation for NGF
US6090781A (en) * 1996-11-06 2000-07-18 Genentech, Inc. Stabilizing formulation for NGF
EP0862452B1 (en) * 1995-11-07 2003-12-10 Genentech, Inc. Stabilizing formulation for ngf
AU3214597A (en) * 1996-05-29 1998-01-05 Universal Preservation Technologies, Inc. Long-term shelf preservation by vitrification
CN1059597C (zh) * 1996-08-08 2000-12-20 陈素兰 神经损伤修复制剂
AU727652B2 (en) * 1997-05-01 2000-12-21 Protechtion Unlimited, Inc. Nerve growth factor as a vaccine adjuvant
US6313089B1 (en) 1997-08-20 2001-11-06 Duke University Complexes of apolipoprotein E and ciliary neurotrophic factor (CNTF) and methods of use
WO1999016460A2 (en) * 1997-09-30 1999-04-08 Duke University Apolipoprotein e/growth factor complexes and methods of use
US6979442B1 (en) 1998-08-17 2005-12-27 Pfizer Inc. Stabilized protein compositions
CN1607958A (zh) 2001-12-21 2005-04-20 诺和诺德医疗保健公司 因子ⅶ多肽的液体组合物
KR20040065278A (ko) * 2001-12-21 2004-07-21 노보 노르디스크 에이/에스 변경된 인자 ⅶ 폴리펩티드의 액체 조성물
US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
PT1517698E (pt) 2002-06-21 2014-11-19 Novo Nordisk Healthcare Ag Composições sólidas estabilizadas de polipéptidos do fator viia
JP2006524195A (ja) * 2003-03-18 2006-10-26 ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト Ｖｉｉ因子ポリペプチドの液状水性医薬組成物
US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
WO2004103398A1 (en) * 2003-05-23 2004-12-02 Novo Nordisk Health Care Ag Protein stabilization in solution
CN1318087C (zh) * 2003-06-06 2007-05-30 北京三诺佳邑生物技术有限责任公司 去白蛋白神经生长因子制剂
EP1641487B1 (en) * 2003-06-25 2012-02-29 Novo Nordisk Health Care AG Liquid composition of factor vii polypeptides
ES2335994T3 (es) * 2003-07-01 2010-04-07 Novo Nordisk Health Care Ag Composicion farmaceutica liquida, acuosa de polipeptidos factor vii.
RU2388460C2 (ru) * 2003-08-14 2010-05-10 Ново Нордиск Хелс Кеа Аг Жидкая водная фармацевтическая композиция, содержащая полипептид фактора vii
KR20130026498A (ko) * 2003-12-19 2013-03-13 노보 노르디스크 헬스 케어 악티엔게젤샤프트 인자 ｖｉｉ 폴리펩티드의 안정화된 조성물
US8168222B2 (en) 2004-09-07 2012-05-01 Board Of Regents Of The University Of Nebraska Amphiphilic polymer-protein conjugates and methods of use thereof
US8017151B2 (en) * 2004-09-07 2011-09-13 Board Of Regents Of The University Of Nebraska By And Behalf Of The University Of Nebraska Medical Center Amphiphilic polymer-protein conjugates and methods of use thereof
JPWO2008020584A1 (ja) * 2006-08-14 2010-01-07 エーザイ・アール・アンド・ディー・マネジメント株式会社 安定な凍結乾燥製剤
JP4111995B1 (ja) * 2006-11-08 2008-07-02 株式会社メディカル・アプライアンス 神経栄養因子産生促進装置
EP1958618A1 (de) * 2007-02-15 2008-08-20 Octapharma AG Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren
EP2349338A2 (fr) * 2008-09-26 2011-08-03 Adocia Complexe constitue d'un polysaccharide et d'une hpb
CN102232932B (zh) * 2010-04-27 2013-06-05 重庆莱美药业股份有限公司 果胶-阿霉素轭合物的冻干制剂及制备方法
WO2012136739A1 (en) 2011-04-07 2012-10-11 Neovacs Method for treating ifnalpha related conditions
EP2812019A1 (en) * 2012-02-08 2014-12-17 Institut National De La Recherche Agronomique Use of beta-nerve growth factor for inducing ovulation in mammals
CN107660149B (zh) * 2015-04-21 2021-04-27 舒泰神（北京）生物制药股份有限公司 一种神经生长因子组合物及注射粉剂
ES2893239T3 (es) * 2015-04-21 2022-02-08 Staidson Beijing Biopharmaceuticals Co Ltd Composición de factor de crecimiento nervioso y polvo de inyección
WO2016169455A1 (zh) * 2015-04-21 2016-10-27 舒泰神（北京）生物制药股份有限公司 神经生长因子组合物和注射粉剂
US9868828B2 (en) * 2015-06-23 2018-01-16 Amolifescience Co., Ltd. Defined three-dimensional microenvironment for stem cell
JPWO2017164349A1 (ja) 2016-03-25 2019-02-07 アステラス製薬株式会社 ＰＥＧ化抗ヒトＮＧＦ抗体Ｆａｂ’フラグメント含有医薬組成物
KR20230162139A (ko) * 2016-06-01 2023-11-28 세르비에 아이피 유케이 리미티드 폴리알킬렌 옥시드-아스파라기나제의 제형, 및 그의 제조 및 사용 방법
CN109260147B (zh) * 2018-10-15 2019-09-13 珠海亿胜生物制药有限公司 一种用于治疗或预防神经损伤的重组人碱性成纤维细胞生长因子注射剂
US11767504B2 (en) 2020-08-14 2023-09-26 Albcura Corporation Albumin compositions and methods of producing and using same
IL302317A (en) 2020-10-28 2023-06-01 Dompe Farm Spa Pharmaceutical packaging including polypropylene containers and aqueous formulations of NGF packed in them

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NZ222413A (en) 1986-11-05 1991-06-25 Ethicon Inc Compositions containing a polypeptide growth factor and a water-soluble cellulose polymer stabiliser
NZ226170A (en) * 1987-09-18 1990-07-26 Ethicon Inc Stable freeze-dried pharmaceutical composition containing epidermal growth factor
IT1219874B (it) * 1988-03-18 1990-05-24 Fidia Farmaceutici Utilizzazione del fattore di crescita nervoso umano e sue composizioni farmaceutiche
US5096885A (en) 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
JPH0418031A (ja) * 1989-02-16 1992-01-22 Hiroshi Saito 損傷治癒促進剤
JP3283288B2 (ja) * 1991-03-08 2002-05-20 電気化学工業株式会社 生理活性ペプチド製剤
JP2818834B2 (ja) * 1991-08-12 1998-10-30 大塚製薬株式会社 ＩＬ−１α安定化医薬製剤

Also Published As

Publication number Publication date
NO317627B1 (no) 2004-11-29
HU228152B1 (en) 2012-12-28
LT96011A (en) 1996-07-25
BG62951B1 (bg) 2000-12-29
JP4592830B2 (ja) 2010-12-08
IL110725A0 (en) 1994-11-11
NO960651D0 (no) 1996-02-19
IL124941A (en) 2006-12-10
IL124941A0 (en) 1999-01-26
LV11279B (en) 1996-10-20
CN1133012A (zh) 1996-10-09
LT4051B (en) 1996-10-25
SK284064B6 (sk) 2004-09-08
JPH10508000A (ja) 1998-08-04
US20010007662A1 (en) 2001-07-12
BG100371A (bg) 1996-12-31
CA2169834A1 (en) 1995-03-02
FI113241B (fi) 2004-03-31
US7074763B2 (en) 2006-07-11
HU9600371D0 (en) 1996-04-29
SI9420048A (en) 1996-10-31
TW427905B (en) 2001-04-01
SI9420048B (sl) 2003-12-31
NZ271873A (en) 1996-10-28
WO1995005845A1 (en) 1995-03-02
PL313084A1 (en) 1996-05-27
ATE226085T1 (de) 2002-11-15
UA43348C2 (uk) 2001-12-17
CZ42496A3 (en) 1996-05-15
RO114742B1 (ro) 1999-07-30
LV11279A (lv) 1996-06-20
PL176387B1 (pl) 1999-05-31
NO960651L (no) 1996-02-19
JP2007314572A (ja) 2007-12-06
KR100341193B1 (ko) 2002-06-21
US6277828B1 (en) 2001-08-21
CA2169834C (en) 2008-11-04
DE69431562D1 (de) 2002-11-21
CZ292422B6 (cs) 2003-09-17
CN1163265C (zh) 2004-08-25
EP0721343A1 (en) 1996-07-17
IL110725A (en) 2004-09-27
PT721343E (pt) 2003-01-31
ZA946333B (en) 1996-02-19
AU7566894A (en) 1995-03-21
AU677699B2 (en) 1997-05-01
DK0721343T3 (da) 2003-02-17
FI960750A (fi) 1996-02-20
RU2126265C1 (ru) 1999-02-20
FI960750A0 (fi) 1996-02-19
BR9407278A (pt) 1996-10-01
SK18396A3 (en) 1996-10-02
HUT74728A (en) 1997-02-28
HK1012990A1 (en) 1999-08-13
EP0721343B1 (en) 2002-10-16
DE69431562T2 (de) 2003-06-18

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