DE69329367D1 - Wachstumshormon-enthaltendeproteinformulierung - Google Patents
Wachstumshormon-enthaltendeproteinformulierungInfo
- Publication number
- DE69329367D1 DE69329367D1 DE69329367T DE69329367T DE69329367D1 DE 69329367 D1 DE69329367 D1 DE 69329367D1 DE 69329367 T DE69329367 T DE 69329367T DE 69329367 T DE69329367 T DE 69329367T DE 69329367 D1 DE69329367 D1 DE 69329367D1
- Authority
- DE
- Germany
- Prior art keywords
- growth hormone
- pct
- formulation
- citrate
- buffer substance
- 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 - Fee Related
Links
- 102000018997 Growth Hormone Human genes 0.000 title abstract 5
- 108010051696 Growth Hormone Proteins 0.000 title abstract 5
- 239000000122 growth hormone Substances 0.000 title abstract 5
- 102000004169 proteins and genes Human genes 0.000 title 1
- 108090000623 proteins and genes Proteins 0.000 title 1
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 abstract 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 abstract 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 abstract 3
- 239000012928 buffer substance Substances 0.000 abstract 3
- 238000009472 formulation Methods 0.000 abstract 3
- 239000000203 mixture Substances 0.000 abstract 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 239000004471 Glycine Substances 0.000 abstract 1
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 235000004279 alanine Nutrition 0.000 abstract 1
- 235000001014 amino acid Nutrition 0.000 abstract 1
- 150000001413 amino acids Chemical class 0.000 abstract 1
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 235000019445 benzyl alcohol Nutrition 0.000 abstract 1
- 235000014633 carbohydrates Nutrition 0.000 abstract 1
- 150000001720 carbohydrates Chemical class 0.000 abstract 1
- 239000000470 constituent Substances 0.000 abstract 1
- 239000013020 final formulation Substances 0.000 abstract 1
- 239000003102 growth factor Substances 0.000 abstract 1
- 239000007972 injectable composition Substances 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
- 239000003755 preservative agent Substances 0.000 abstract 1
- 230000002335 preservative effect Effects 0.000 abstract 1
- 238000000746 purification Methods 0.000 abstract 1
- 150000005846 sugar alcohols Chemical class 0.000 abstract 1
Classifications
-
- 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
- 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
- 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)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Endocrinology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9201073A SE9201073D0 (sv) | 1992-04-03 | 1992-04-03 | Protein formulation |
SE9201073 | 1992-04-03 | ||
PCT/SE1993/000281 WO1993019776A1 (en) | 1992-04-03 | 1993-04-01 | Protein formulation comprising growth hormone |
Publications (3)
Publication Number | Publication Date |
---|---|
DE69329367D1 true DE69329367D1 (de) | 2000-10-12 |
DE69329367T2 DE69329367T2 (de) | 2001-06-21 |
DE69329367T3 DE69329367T3 (de) | 2008-06-19 |
Family
ID=20385860
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE69329367T Expired - Fee Related DE69329367T3 (de) | 1992-04-03 | 1993-04-01 | Wachstumshormon-enthaltende proteinformulierung |
Country Status (15)
Country | Link |
---|---|
US (1) | US5567677A (de) |
EP (1) | EP0587858B2 (de) |
JP (1) | JP3268557B2 (de) |
AT (1) | ATE196092T1 (de) |
AU (1) | AU666007B2 (de) |
CA (1) | CA2102693C (de) |
DE (1) | DE69329367T3 (de) |
DK (1) | DK0587858T3 (de) |
ES (1) | ES2150940T5 (de) |
GR (1) | GR3034925T3 (de) |
NO (1) | NO310804B1 (de) |
NZ (1) | NZ251498A (de) |
PT (1) | PT587858E (de) |
SE (1) | SE9201073D0 (de) |
WO (1) | WO1993019776A1 (de) |
Families Citing this family (56)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5981485A (en) * | 1997-07-14 | 1999-11-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
US5763394A (en) * | 1988-04-15 | 1998-06-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
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 |
DK204791D0 (da) * | 1991-12-20 | 1991-12-20 | Novo Nordisk As | Hidtil ukendt farmaceutisk praeparat |
US5849700A (en) * | 1991-12-20 | 1998-12-15 | Novo Nordisk A/S | Pharmaceutical formulation |
FR2686899B1 (fr) | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant. |
FR2719479B1 (fr) * | 1994-05-04 | 1996-07-26 | Sanofi Elf | Formulation stable lyophilisée comprenant une protéine: kit de dosage. |
US5631225A (en) * | 1994-10-13 | 1997-05-20 | Novo Nordisk A/S | Pharmaceutical formulation |
US5654278A (en) * | 1994-10-13 | 1997-08-05 | Novo Nordisk A/S | Composition and method comprising growth hormone and leucine |
IL115592A (en) * | 1994-10-13 | 2000-07-26 | Novo Nordisk As | Stabilized pharmaceutical formulation comprising a growth hormone and leucine |
US5547696A (en) * | 1994-10-13 | 1996-08-20 | Novo Nordisk A/S | Pharmaceutical formulation |
US5705482A (en) * | 1995-01-13 | 1998-01-06 | Novo Nordisk A/S | Pharmaceutical formulation |
US5552385A (en) * | 1995-06-05 | 1996-09-03 | Novo Nordisk A/S | Pharmaceutical formulation |
DE19539574A1 (de) | 1995-10-25 | 1997-04-30 | Boehringer Mannheim Gmbh | Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren |
GB9526733D0 (en) * | 1995-12-30 | 1996-02-28 | Delta Biotechnology Ltd | Fusion proteins |
AUPN801296A0 (en) | 1996-02-12 | 1996-03-07 | Csl Limited | Stabilised growth hormone formulation and method of preparation thereof |
US20070179096A1 (en) | 1996-04-24 | 2007-08-02 | Novo Nordisk A/S | Pharmaceutical Formulation |
ZA9711733B (en) | 1996-12-31 | 1998-07-01 | Monsanto Co | Method for solubilization and naturation of somatotropins |
ZA9711731B (en) * | 1996-12-31 | 1998-07-01 | Monsanto Co | Aqueous glycerol formulations of somatotropin |
JP3723857B2 (ja) * | 1998-02-04 | 2005-12-07 | 日本ケミカルリサーチ株式会社 | ヒト成長ホルモン含有水性医薬組成物 |
US6979442B1 (en) | 1998-08-17 | 2005-12-27 | Pfizer Inc. | Stabilized protein compositions |
BR0013162A (pt) * | 1999-07-12 | 2002-05-28 | Grandis Biotech Gmbh | Formulações de hormÈnio de crescimento |
JP2004515467A (ja) | 2000-08-07 | 2004-05-27 | ネクター セラピューティックス | 吸入可能な、噴霧乾燥した、最少の凝集物を有する4−ヘリックスバンドルタンパク質粉末 |
GB2371227A (en) * | 2001-01-10 | 2002-07-24 | Grandis Biotech Gmbh | Crystallisation - resistant aqueous growth hormone formulations |
AU2002342653A1 (en) | 2001-05-14 | 2002-11-25 | The Gouvernment Of The United States Of America, Represented By The Secretary, Department Of Health | Modified growth hormone |
WO2003059934A2 (en) | 2001-12-21 | 2003-07-24 | Human Genome Sciences, Inc. | Albumin fusion proteins |
US7375073B2 (en) * | 2002-02-27 | 2008-05-20 | Wake Forest University Health Sciences | Angiotensin-(1-7) and angiotensin-(1-7) agonists for inhibition of cancer cell growth |
US20070065469A1 (en) * | 2002-07-09 | 2007-03-22 | Michael Betz | Liquid formulations with high concentration of human growth hormone (high) comprising glycine |
CN1665540A (zh) * | 2002-07-09 | 2005-09-07 | 桑多斯股份公司 | 含1,2-丙二醇的高浓度人生长激素液体制剂 |
JP4949828B2 (ja) * | 2003-03-18 | 2012-06-13 | アレス トレーディング ソシエテ アノニム | 溶液中での成長ホルモンの安定化 |
ATE554792T1 (de) | 2003-12-23 | 2012-05-15 | Pharmacia Corp | Stabiles wachstumshormon-flüssigformulierung |
SI1740213T1 (sl) * | 2004-04-07 | 2012-04-30 | Ares Trading Sa | Tekoäśa formulacija rastnega hormona |
WO2006017647A1 (en) * | 2004-08-03 | 2006-02-16 | Transtech Pharma, Inc. | Rage fusion proteins and methods of use |
US20060078562A1 (en) * | 2004-08-03 | 2006-04-13 | Mjalli Adnan M | RAGE fusion proteins and methods of use |
EP1800689B1 (de) * | 2004-08-24 | 2016-12-28 | Daiichi Sankyo Company, Limited | Flüssige zubereitung von physiologisch aktivem peptid |
MX2007005327A (es) * | 2004-11-09 | 2007-08-02 | Ares Trading Sa | Metodo para purificacion de la hormona foliculo estimulante (hfe). |
US20070015689A1 (en) * | 2005-06-23 | 2007-01-18 | Alza Corporation | Complexation of metal ions with polypeptides |
SI1917276T1 (en) * | 2005-08-26 | 2018-05-31 | Ares Trading S.A. | PROCEDURE FOR PREPARATION OF GLYCOSYLATED INTERFERONE BETA |
US7947304B2 (en) * | 2005-11-02 | 2011-05-24 | Transpharma Medical Ltd. | Human growth hormone patch formulations |
US8604175B2 (en) * | 2005-12-09 | 2013-12-10 | Ares Trading S.A. | Method for purifying FSH or a FSH mutant |
CN101331384B (zh) * | 2005-12-23 | 2011-11-09 | G科德***有限公司 | 定位图形 |
BRPI0707640A2 (pt) * | 2006-02-09 | 2011-05-10 | Transtech Pharma Inc | proteÍnas de fusço do rage e mÉtodos de uso |
EA017291B1 (ru) | 2006-05-05 | 2012-11-30 | Транстек Фарма, Инк. | Белки слияния на основе rage, их композиции и способы их применения |
WO2008100470A2 (en) * | 2007-02-15 | 2008-08-21 | Transtech Pharma, Inc. | Rage - immunoglobulin fusion proteins |
CA2687141C (en) | 2007-05-22 | 2014-04-01 | Amgen Inc. | Compositions and methods for producing bioactive fusion proteins |
EP2203465A1 (de) * | 2007-10-22 | 2010-07-07 | Merck Serono S.A. | Verfahren zu reinigung eines fc enthaltenden proteins |
CA2702448A1 (en) * | 2007-10-22 | 2009-04-30 | Merck Serono S.A. | Method for purifying fc-fusion proteins |
EP2421892A1 (de) | 2009-04-20 | 2012-02-29 | Pfizer Inc. | Steuerung der proteinglycosylierung und damit in zusammenhang stehende zusammensetzungen und verfahren |
WO2010128141A1 (en) * | 2009-05-07 | 2010-11-11 | Novo Nordisk Health Care Ag | Stable pharmaceutical compositions of peptide derivatized using an oxime linker |
BR112012011539A8 (pt) * | 2009-11-17 | 2017-12-26 | Ipsen Pharma Sas | formulação para a combinação de hgh e rhigf-1 |
KR101337797B1 (ko) * | 2010-07-14 | 2013-12-06 | 한미사이언스 주식회사 | 지속형 인간 성장 호르몬 결합체 액상 제제 |
US10064951B2 (en) | 2012-03-30 | 2018-09-04 | Hanmi Science Co., Ltd. | Liquid formulation of highly concentrated long-acting human growth hormone conjugate |
BR112016006455A2 (pt) * | 2013-09-27 | 2017-08-01 | Hanmi Pharm Ind Co Ltd | ?formulação de conjugado de hormônio de crescimento humano de ação prolongada? |
CA2931547A1 (en) | 2013-12-09 | 2015-06-18 | Durect Corporation | Pharmaceutically active agent complexes, polymer complexes, and compositions and methods involving the same |
WO2016011281A1 (en) * | 2014-07-17 | 2016-01-21 | Teva Pharmaceutical Industries Ltd. | FORMULATIONS OF AN ALBUMIN-hGH FUSION PROTEIN |
Family Cites Families (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4783441A (en) * | 1979-04-30 | 1988-11-08 | Hoechst Aktiengesellschaft | Aqueous protein solutions stable to denaturation |
US4774091A (en) * | 1983-10-14 | 1988-09-27 | Sumitomo Pharmaceuticals Company, Ltd. | Long-term sustained-release preparation |
DE3579911D1 (de) * | 1984-12-24 | 1990-10-31 | Sumitomo Pharma | Stabiles grf-praeparat. |
IL79552A0 (en) * | 1985-07-30 | 1986-10-31 | Int Minerals & Chem Corp | Stabilization of growth promoting hormones |
US4917685A (en) * | 1986-05-16 | 1990-04-17 | International Minerals & Chem. Corp. | Delivery device for the administration of stabilized growth promoting hormones |
US4816568A (en) * | 1986-05-16 | 1989-03-28 | International Minerals & Chemical Corp. | Stabilization of growth hormones |
ATE82506T1 (de) * | 1987-08-21 | 1992-12-15 | Imcera Group Inc | Stabilisierung von wachstumshormonen. |
US4837202A (en) † | 1987-09-14 | 1989-06-06 | Pitman-Moore, Inc. | Method for stimulating the immune system |
US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
JPH01308235A (ja) * | 1988-06-03 | 1989-12-12 | Yamanouchi Pharmaceut Co Ltd | ヒト成長ホルモン経鼻剤 |
US5008244A (en) * | 1989-05-15 | 1991-04-16 | Pitman-Moore, Inc. | Method for increasing fertility in animals |
CA2020654A1 (en) * | 1989-07-07 | 1991-01-08 | Yohko Akiyama | Stabilized fgf composition and production thereof |
IN172427B (de) * | 1989-11-14 | 1993-07-24 | Fidia Spa | |
US5217954A (en) * | 1990-04-04 | 1993-06-08 | Scios Nova Inc. | Formulations for stabilizing fibroblast growth factor |
US5126324A (en) * | 1990-06-07 | 1992-06-30 | Genentech, Inc. | Method of enhancing growth in patients using combination therapy |
WO1992017200A2 (en) * | 1991-03-28 | 1992-10-15 | Genentech, Inc. | Stable growth hormone metal ion formulations |
DK204791D0 (da) * | 1991-12-20 | 1991-12-20 | Novo Nordisk As | Hidtil ukendt farmaceutisk praeparat |
JP3368282B2 (ja) † | 1992-04-30 | 2003-01-20 | ミレニアム ファーマシューティカルズ,インコーポレイティド | 安定なポリペプチド組成物 |
DK0652766T4 (da) * | 1992-07-31 | 2008-06-09 | Genentech Inc | Vandigt præparat indeholdende humant væksthormon |
-
1992
- 1992-04-03 SE SE9201073A patent/SE9201073D0/xx unknown
-
1993
- 1993-04-01 CA CA002102693A patent/CA2102693C/en not_active Expired - Lifetime
- 1993-04-01 JP JP51737893A patent/JP3268557B2/ja not_active Expired - Lifetime
- 1993-04-01 NZ NZ251498A patent/NZ251498A/en not_active IP Right Cessation
- 1993-04-01 DE DE69329367T patent/DE69329367T3/de not_active Expired - Fee Related
- 1993-04-01 WO PCT/SE1993/000281 patent/WO1993019776A1/en active IP Right Grant
- 1993-04-01 US US08/162,017 patent/US5567677A/en not_active Expired - Lifetime
- 1993-04-01 AU AU39135/93A patent/AU666007B2/en not_active Ceased
- 1993-04-01 DK DK93908252T patent/DK0587858T3/da active
- 1993-04-01 AT AT93908252T patent/ATE196092T1/de not_active IP Right Cessation
- 1993-04-01 PT PT93908252T patent/PT587858E/pt unknown
- 1993-04-01 ES ES93908252T patent/ES2150940T5/es not_active Expired - Lifetime
- 1993-04-01 EP EP93908252A patent/EP0587858B2/de not_active Expired - Lifetime
- 1993-11-30 NO NO19934355A patent/NO310804B1/no unknown
-
2000
- 2000-11-28 GR GR20000402632T patent/GR3034925T3/el unknown
Also Published As
Publication number | Publication date |
---|---|
ES2150940T3 (es) | 2000-12-16 |
DE69329367T2 (de) | 2001-06-21 |
CA2102693A1 (en) | 1993-10-04 |
PT587858E (pt) | 2001-02-28 |
WO1993019776A1 (en) | 1993-10-14 |
AU3913593A (en) | 1993-11-08 |
US5567677A (en) | 1996-10-22 |
EP0587858B1 (de) | 2000-09-06 |
JP3268557B2 (ja) | 2002-03-25 |
DE69329367T3 (de) | 2008-06-19 |
ATE196092T1 (de) | 2000-09-15 |
JPH06508156A (ja) | 1994-09-14 |
DK0587858T3 (da) | 2000-12-18 |
SE9201073D0 (sv) | 1992-04-03 |
NO934355L (no) | 1993-12-01 |
EP0587858B2 (de) | 2007-11-14 |
ES2150940T5 (es) | 2008-04-16 |
AU666007B2 (en) | 1996-01-25 |
EP0587858A1 (de) | 1994-03-23 |
GR3034925T3 (en) | 2001-02-28 |
NO310804B1 (no) | 2001-09-03 |
CA2102693C (en) | 2008-06-17 |
NZ251498A (en) | 1995-07-26 |
NO934355D0 (no) | 1993-11-30 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
8327 | Change in the person/name/address of the patent owner |
Owner name: PHARMACIA AB, STOCKHOLM, SE |
|
8363 | Opposition against the patent | ||
8366 | Restricted maintained after opposition proceedings | ||
8327 | Change in the person/name/address of the patent owner |
Owner name: PFIZER HEALTH AB, STOCKHOLM, SE |
|
8339 | Ceased/non-payment of the annual fee |