ES2185625T3 - Formulacion farmaceutica estabilizada que incluye hormona de crecimiento e histidina. - Google Patents

Formulacion farmaceutica estabilizada que incluye hormona de crecimiento e histidina.

Info

Publication number
ES2185625T3
ES2185625T3 ES93902089T ES93902089T ES2185625T3 ES 2185625 T3 ES2185625 T3 ES 2185625T3 ES 93902089 T ES93902089 T ES 93902089T ES 93902089 T ES93902089 T ES 93902089T ES 2185625 T3 ES2185625 T3 ES 2185625T3
Authority
ES
Spain
Prior art keywords
histidine
hormone
growth
pharmaceutical formulation
stabilized pharmaceutical
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
ES93902089T
Other languages
English (en)
Inventor
Hans Holmegaard Soerensen
Lars Skriver
Annie Rassing Hoelgaard
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.)
Novo Nordisk AS
Original Assignee
Novo Nordisk 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
Priority claimed from DK204691A external-priority patent/DK204691D0/da
Priority claimed from DK136492A external-priority patent/DK136492D0/da
Application filed by Novo Nordisk AS filed Critical Novo Nordisk AS
Application granted granted Critical
Publication of ES2185625T3 publication Critical patent/ES2185625T3/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
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/61—Growth hormone [GH], i.e. somatotropin
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Endocrinology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (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

UN PREPARADO FARMACEUTICO QUE COMPRENDE UNA HORMONA DE CRECIMIENTO Y HISTIDINA O UN DERIVADO DE LA HISTIDINA COMO ADITIVO O SUSTANCIA TAMPONIZADORA MUESTRA UNA MUY ALTA ESTABILIDAD CONTRA LA DESAMIDACION, OXIDACION Y DESDOBLAMIENTO DE LOS ENLACES PEPTIDO. LA ESTABILIDAD DEL PRODUCTO PERMITE EL ALMACENAMIENTO Y CARGA DE ELLO EN UN ESTADO LIOFILIZADO O EN LA FORMA DE UN PREPARADO DISUELTO O REDISUELTO A TEMPERATURA AMBIENTE. LA CRISTALIZACION DE LA HORMONA DE CRECIMIENTO EN LA PRESENCIA DE LA HISTIDINA O UN DERIVADO SUYO DA DESARROLLO A UNA MAS ALTA PRODUCCION DE CRISTALES QUE TIENEN UNA PUREZA MAS ALTA QUE LOS METODOS CONOCIDOS.
ES93902089T 1991-12-20 1992-12-16 Formulacion farmaceutica estabilizada que incluye hormona de crecimiento e histidina. Expired - Lifetime ES2185625T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DK204691A DK204691D0 (da) 1991-12-20 1991-12-20 Hidtil ukendt farmaceutisk praeparat
DK136492A DK136492D0 (da) 1992-11-10 1992-11-10 A pharmaceutical formulation

Publications (1)

Publication Number Publication Date
ES2185625T3 true ES2185625T3 (es) 2003-05-01

Family

ID=26065653

Family Applications (2)

Application Number Title Priority Date Filing Date
ES01128974T Expired - Lifetime ES2291264T3 (es) 1991-12-20 1992-12-16 Formulacion farmaceutica estabilizada comprendiendo una hormona de crecimiento e histidina.
ES93902089T Expired - Lifetime ES2185625T3 (es) 1991-12-20 1992-12-16 Formulacion farmaceutica estabilizada que incluye hormona de crecimiento e histidina.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ES01128974T Expired - Lifetime ES2291264T3 (es) 1991-12-20 1992-12-16 Formulacion farmaceutica estabilizada comprendiendo una hormona de crecimiento e histidina.

Country Status (24)

Country Link
EP (2) EP0618807B1 (es)
JP (2) JP2950617B2 (es)
KR (1) KR100266502B1 (es)
AT (2) ATE368472T1 (es)
AU (1) AU667503B2 (es)
BG (1) BG63075B1 (es)
CA (1) CA2125855C (es)
CZ (1) CZ283361B6 (es)
DE (3) DE10399015I1 (es)
DK (1) DK0618807T3 (es)
ES (2) ES2291264T3 (es)
FI (1) FI115116B (es)
HU (1) HUT69402A (es)
IL (1) IL104152A (es)
MX (1) MX9207374A (es)
NL (1) NL300126I1 (es)
NO (1) NO942300L (es)
NZ (1) NZ246556A (es)
PT (1) PT618807E (es)
RO (1) RO111990B1 (es)
RU (1) RU2122426C1 (es)
SK (1) SK279641B6 (es)
UA (1) UA41502C2 (es)
WO (1) WO1993012812A1 (es)

Families Citing this family (64)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5849704A (en) * 1991-12-20 1998-12-15 Novo Nordisk A/S Pharmaceutical formulation
US6022858A (en) * 1991-12-20 2000-02-08 Novo Nordisk A/S Pharmaceutical formulation of human-growth hormone pretreated with zinc salt
US5849700A (en) * 1991-12-20 1998-12-15 Novo Nordisk A/S Pharmaceutical formulation
DK204791D0 (da) * 1991-12-20 1991-12-20 Novo Nordisk As Hidtil ukendt farmaceutisk praeparat
US6288030B1 (en) * 1993-12-22 2001-09-11 Amgen Inc. Stem cell factor formulations and methods
DK0804223T3 (da) * 1994-06-17 2000-01-24 Applied Research Systems Farmaceutiske præparater indeholdende hGH
IL114030A (en) * 1994-06-27 2000-08-13 Hayashibara Biochem Lab Saccharide composition with a lesser reducibility its preparation and compositions containing it
US5654278A (en) * 1994-10-13 1997-08-05 Novo Nordisk A/S Composition and method comprising growth hormone and leucine
US5547696A (en) * 1994-10-13 1996-08-20 Novo Nordisk A/S Pharmaceutical formulation
IL115592A (en) * 1994-10-13 2000-07-26 Novo Nordisk As Stabilized pharmaceutical formulation comprising a growth hormone and leucine
US5631225A (en) * 1994-10-13 1997-05-20 Novo Nordisk A/S Pharmaceutical formulation
US5705482A (en) * 1995-01-13 1998-01-06 Novo Nordisk A/S Pharmaceutical formulation
ZA96122B (en) * 1995-01-13 1996-07-24 Novo Nordisk As A pharmaceutical formulation
KR19980701351A (ko) * 1995-01-13 1998-05-15 슈타르 피아 성장호르몬 및 Ｘ-Ｌｙｓ를 함유하는 안정화된 약제조제물(A STABILIZED PHARMACEUTICAL FORMULATION COMPRISING A GROWTH HORMONE AND X-Lys
US5552385A (en) * 1995-06-05 1996-09-03 Novo Nordisk A/S Pharmaceutical formulation
US6936289B2 (en) 1995-06-07 2005-08-30 Danisco A/S Method of improving the properties of a flour dough, a flour dough improving composition and improved food products
ZA965367B (en) * 1995-07-12 1997-01-23 Novo Nordisk As A pharmaceutical formulation
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
KR100236393B1 (ko) 1996-02-02 1999-12-15 나까니시 히로유끼 사람성장호르몬을 함유하는 의약제제
US20020077461A1 (en) * 1996-04-24 2002-06-20 Soren Bjorn Pharmaceutical formulation
US20070179096A1 (en) 1996-04-24 2007-08-02 Novo Nordisk A/S Pharmaceutical Formulation
EP1433852B1 (en) 1997-04-09 2006-06-28 Danisco A/S Use of lipase for improving doughs and baked products
WO1999024015A1 (en) * 1997-11-12 1999-05-20 Alza Corporation Buffered drug formulations for transdermal electrotransport delivery
EP2311436A1 (en) * 1998-04-27 2011-04-20 Altus Pharmaceuticals Inc. Stabilized protein crystals, formulations containing them and methods of making them
KR20080011353A (ko) 2000-02-24 2008-02-01 몬산토 테크놀로지 엘엘씨 소마토트로핀의 지속적인 방출을 위한 비수성 주사제제들
AU2001271491A1 (en) 2000-06-26 2002-01-08 Monsanto Technology Llc Non-aqueous surfactant-containing formulations for extended release of somatotropin
US6664234B1 (en) 2000-06-30 2003-12-16 Monsanto Technology Llc Non-aqueous injectable formulation preparation with pH adjusted for extended release of somatotropin
WO2002011695A2 (en) 2000-08-07 2002-02-14 Inhale Therapeutic Systems, Inc. Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation
JP5485489B2 (ja) 2000-08-11 2014-05-07 中外製薬株式会社 抗体含有安定化製剤
NZ528260A (en) 2001-05-18 2005-09-30 Danisco Method of improving dough and bread quality with the addition of an enzyme that hydrolyses a glycolipid and a phospholipid and incapable of hydrolysing a triglyceride or monoglyceride
CA2512052C (en) 2002-12-31 2016-06-21 Altus Pharmaceuticals Inc. Human growth hormone crystals and methods for preparing them
JP2006523609A (ja) * 2002-12-31 2006-10-19 アルタス ファーマシューティカルズ インコーポレイテッド タンパク質結晶およびイオン性ポリマーの複合体
MXPA05007654A (es) 2003-01-17 2005-09-30 Danisco Metodo.
EP2107069B1 (en) 2003-08-05 2013-01-16 Novo Nordisk A/S Novel insulin derivatives
GB0405637D0 (en) 2004-03-12 2004-04-21 Danisco Protein
EA014985B1 (ru) 2004-07-16 2011-04-29 Даниско А/С Способ ферментативного рафинирования пищевых масел гидратацией и применение липидацилтрансферазы для осуществления способа
CA2589889C (en) * 2004-12-15 2013-07-30 Amgen Inc. Therapeutic formulations of keratinocyte growth factor
KR101224781B1 (ko) * 2004-12-22 2013-01-21 암브룩스, 인코포레이티드 비천연적으로 코딩된 아미노산을 포함하는 인간 성장호르몬의 조제물
CN101268098A (zh) * 2005-08-30 2008-09-17 诺沃-诺迪斯克保健股份有限公司 聚乙二醇化生长激素的液体制剂
WO2007033427A1 (en) * 2005-09-23 2007-03-29 Metabolic Pharmaceuticals Limited Stabilisation of peptides with basic amino acids
US20090074882A1 (en) 2005-12-28 2009-03-19 Novo Nordisk A/S Insulin compositions and method of making a composition
WO2008003750A2 (en) 2006-07-07 2008-01-10 Novo Nordisk Health Care Ag New protein conjugates and methods for their preparation
EP2120869A2 (en) * 2006-12-18 2009-11-25 Altus Pharmaceuticals Inc. Human growth hormone formulations
JP5552046B2 (ja) 2007-06-13 2014-07-16 ノボ・ノルデイスク・エー／エス インスリン誘導体を含有する薬学的製剤
KR20110085985A (ko) 2008-10-30 2011-07-27 노보 노르디스크 에이/에스 하루 한번 주사 빈도보다 적은 인슐린 주사를 사용한 진성 당뇨병의 치료
PL2889043T3 (pl) * 2008-12-16 2019-09-30 Genzyme Corporation Syntetyczne związki pośrednie do wytwarzania koniugatów oligosacharyd-białko
US9238878B2 (en) 2009-02-17 2016-01-19 Redwood Bioscience, Inc. Aldehyde-tagged protein-based drug carriers and methods of use
NZ600361A (en) 2009-12-21 2014-06-27 Ambrx Inc Modified bovine somatotropin polypeptides and their uses
EP2516455A4 (en) 2009-12-21 2013-05-22 Ambrx Inc MODIFIED SWINE SOMATOTROPIN POLYPEPTIDES AND THEIR USES
JP5924343B2 (ja) * 2010-09-21 2016-05-25 フェリング ベスローテン フェンノートシャップ 組換えヒト成長ホルモン産生の改善された方法
BR112013010345A2 (pt) 2010-10-27 2017-07-25 Novo Nordisk As tratamento de diabetes melitus usando as injeções de insulina administradas com intervalos de variação da injeção
JP6162606B2 (ja) 2011-01-14 2017-07-12 レッドウッド バイオサイエンス， インコーポレイテッド アルデヒド−タグ付き免疫グロブリンポリペプチド及びその使用方法
WO2013183055A1 (en) 2012-06-05 2013-12-12 Neuroderm Ltd Compositions comprising apomorphine and organic acids and uses thereof
ITBO20120368A1 (it) 2012-07-06 2014-01-07 Alfa Wassermann Spa Composizioni comprendenti rifaximina e amminoacidi, cristalli di rifaximina derivanti da tali composizioni e loro uso.
JP2016519127A (ja) 2013-04-30 2016-06-30 ノヴォ ノルディスク アー／エス 新規投与レジメン
US11559580B1 (en) * 2013-09-17 2023-01-24 Blaze Bioscience, Inc. Tissue-homing peptide conjugates and methods of use thereof
AU2015416589B2 (en) * 2015-12-10 2021-04-01 Menicon Co., Ltd. Peptide composition
CN109071634A (zh) 2016-04-26 2018-12-21 R.P.谢勒技术有限责任公司 抗体偶联物及其制备和使用方法
AU2019274826A1 (en) * 2018-05-25 2021-01-07 Dr. Reddy's Laboratories Ltd. Stable fusion protein formulation
US11738068B2 (en) * 2018-06-25 2023-08-29 Jcr Pharmaceuticals Co., Ltd. Protein-containing aqueous liquid formulation
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
IL281938B2 (en) 2018-10-26 2024-04-01 Novo Nordisk As Stable semaglutide compositions and uses thereof
US12343383B2 (en) 2019-07-12 2025-07-01 Novo Nordisk A/S High concentration insulin formulation
WO2022197963A1 (en) * 2021-03-19 2022-09-22 Pfizer Inc. Long-acting growth hormone compositions

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8504099D0 (en) 1985-02-18 1985-03-20 Wellcome Found Physiologically active substances
US4816568A (en) * 1986-05-16 1989-03-28 International Minerals & Chemical Corp. Stabilization of growth hormones
US4917685A (en) * 1986-05-16 1990-04-17 International Minerals & Chem. Corp. Delivery device for the administration of stabilized growth promoting hormones
EP0374120A3 (en) * 1988-12-13 1991-07-31 Monsanto Company Comosition for controlled release of polypeptides
DK168790D0 (es) * 1990-07-13 1990-07-13 Novo Nordisk As

Also Published As

Publication number Publication date
HUT69402A (en) 1995-09-28
SK279641B6 (sk) 1999-01-11
IL104152A0 (en) 1993-05-13
WO1993012812A1 (en) 1993-07-08
NO942300L (no) 1994-08-19
MX9207374A (es) 1993-07-01
NL300126I1 (nl) 2003-07-01
CZ150794A3 (en) 1995-01-18
CA2125855A1 (en) 1993-07-08
EP1197222A3 (en) 2004-02-04
FI942906A0 (fi) 1994-06-17
DE10399015I2 (de) 2008-08-07
HU9401832D0 (en) 1994-09-28
ATE227583T1 (de) 2002-11-15
DE69233704T2 (de) 2008-05-21
CZ283361B6 (cs) 1998-03-18
FI942906L (fi) 1994-06-17
RU94045932A (ru) 1997-04-20
CA2125855C (en) 2008-05-13
JPH11315031A (ja) 1999-11-16
UA41502C2 (uk) 2001-09-17
SK75494A3 (en) 1995-03-08
DK0618807T3 (da) 2003-03-03
JPH07502516A (ja) 1995-03-16
PT618807E (pt) 2003-03-31
RU2122426C1 (ru) 1998-11-27
JP2950617B2 (ja) 1999-09-20
EP1197222A2 (en) 2002-04-17
DE10399015I1 (de) 2012-05-03
DE69232847T2 (de) 2003-09-11
FI115116B (fi) 2005-03-15
BG98806A (bg) 1995-02-28
EP0618807B1 (en) 2002-11-13
NZ246556A (en) 1996-03-26
AU3344693A (en) 1993-07-28
KR100266502B1 (ko) 2000-09-15
NO942300D0 (no) 1994-06-17
BG63075B1 (bg) 2001-03-30
EP0618807A1 (en) 1994-10-12
ES2291264T3 (es) 2008-03-01
DE69233704D1 (de) 2007-09-13
EP1197222B1 (en) 2007-08-01
IL104152A (en) 1998-06-15
RO111990B1 (ro) 1997-04-30
DE69232847D1 (de) 2002-12-19
AU667503B2 (en) 1996-03-28
ATE368472T1 (de) 2007-08-15

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