MX9304613A - Formulacion acuosa, farmaceuticamente aceptable y estable de hormona de crecimiento humana. - Google Patents
Formulacion acuosa, farmaceuticamente aceptable y estable de hormona de crecimiento humana.Info
- Publication number
- MX9304613A MX9304613A MX9304613A MX9304613A MX9304613A MX 9304613 A MX9304613 A MX 9304613A MX 9304613 A MX9304613 A MX 9304613A MX 9304613 A MX9304613 A MX 9304613A MX 9304613 A MX9304613 A MX 9304613A
- Authority
- MX
- Mexico
- Prior art keywords
- growth hormone
- human growth
- pharmaceutically
- aqueous
- stable formulation
- Prior art date
Links
- 102000002265 Human Growth Hormone Human genes 0.000 title abstract 2
- 108010000521 Human Growth Hormone Proteins 0.000 title abstract 2
- 239000000854 Human Growth Hormone Substances 0.000 title abstract 2
- 238000009472 formulation Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title 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
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 239000013011 aqueous formulation Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 230000007935 neutral effect Effects 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- 239000003755 preservative agent Substances 0.000 abstract 1
- 230000002335 preservative effect Effects 0.000 abstract 1
- 150000003839 salts 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
- A61K47/10—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
- 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
- A61K47/06—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
- 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
- A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
La presente invención describe una formulación acuosa farmacéuticamente aceptable, que contiene hormona de crecimiento humana, un amortiguador, un surfactante no iònico, y, opcionalmente, una sal neutra, manitol, o un conservador. También están descritos medios y métodos asociados para preparar, almacenar, y usar tales formulaciones.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US92340192A | 1992-07-31 | 1992-07-31 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX9304613A true MX9304613A (es) | 1994-03-31 |
Family
ID=25448638
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX9304613A MX9304613A (es) | 1992-07-31 | 1993-07-30 | Formulacion acuosa, farmaceuticamente aceptable y estable de hormona de crecimiento humana. |
Country Status (15)
| Country | Link |
|---|---|
| EP (2) | EP0955062B1 (es) |
| JP (2) | JP4018133B2 (es) |
| AT (2) | ATE197405T1 (es) |
| AU (1) | AU686567C (es) |
| CA (3) | CA2337745C (es) |
| DE (2) | DE69329651T3 (es) |
| DK (2) | DK0652766T4 (es) |
| ES (2) | ES2286868T3 (es) |
| GR (1) | GR3035144T3 (es) |
| IL (1) | IL106524A (es) |
| MD (1) | MD1699F2 (es) |
| MX (1) | MX9304613A (es) |
| NZ (1) | NZ255158A (es) |
| PT (1) | PT652766E (es) |
| WO (1) | WO1994003198A1 (es) |
Families Citing this family (56)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5763394A (en) * | 1988-04-15 | 1998-06-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| US5981485A (en) | 1997-07-14 | 1999-11-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| US6022858A (en) * | 1991-12-20 | 2000-02-08 | Novo Nordisk A/S | Pharmaceutical formulation of human-growth hormone pretreated with zinc salt |
| US5849704A (en) * | 1991-12-20 | 1998-12-15 | Novo Nordisk A/S | Pharmaceutical formulation |
| 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 |
| FR2686899B1 (fr) | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant. |
| SE9201073D0 (sv) * | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
| US5877016A (en) | 1994-03-18 | 1999-03-02 | Genentech, Inc. | Human trk receptors and neurotrophic factor inhibitors |
| WO1995035116A1 (en) * | 1994-06-17 | 1995-12-28 | Applied Research Systems | Hgh containing pharmaceutical compositions |
| 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 |
| 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 |
| US6790439B1 (en) * | 1995-06-07 | 2004-09-14 | Zymogenetics, Inc. | Thrombopoietin compositions |
| US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| SE9502927D0 (sv) * | 1995-08-24 | 1995-08-24 | Pharmacia Ab | Solution containing IGF-I |
| 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 |
| US20020077461A1 (en) * | 1996-04-24 | 2002-06-20 | Soren Bjorn | Pharmaceutical formulation |
| SE9704405D0 (sv) * | 1997-11-28 | 1997-11-28 | Pharmacia & Upjohn Ab | New syringe |
| 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 |
| CN1309567A (zh) * | 1998-07-23 | 2001-08-22 | 伊莱利利公司 | Fsh和fsh变体制剂,产品和方法 |
| US20030166525A1 (en) | 1998-07-23 | 2003-09-04 | Hoffmann James Arthur | FSH Formulation |
| SK252002A3 (en) * | 1999-07-12 | 2002-06-04 | Grandis Biotech Gmbh | Growth hormone formulations |
| EP1276856A4 (en) | 2000-04-12 | 2004-06-09 | Human Genome Sciences Inc | ALBUMIN FUSION PROTEINS |
| CA2380423A1 (en) * | 2000-05-17 | 2001-11-22 | Bionebraska, Inc. | Peptide pharmaceutical formulations |
| GB2371227A (en) * | 2001-01-10 | 2002-07-24 | Grandis Biotech Gmbh | Crystallisation - resistant aqueous growth hormone formulations |
| US7507413B2 (en) | 2001-04-12 | 2009-03-24 | Human Genome Sciences, Inc. | Albumin fusion proteins |
| US20080194481A1 (en) | 2001-12-21 | 2008-08-14 | Human Genome Sciences, Inc. | Albumin Fusion Proteins |
| WO2005003296A2 (en) | 2003-01-22 | 2005-01-13 | Human Genome Sciences, Inc. | Albumin fusion proteins |
| JP5424521B2 (ja) | 2001-12-21 | 2014-02-26 | ヒューマン ジノーム サイエンシーズ, インコーポレイテッド | アルブミン融合タンパク質 |
| 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 |
| KR20050090430A (ko) | 2002-12-31 | 2005-09-13 | 알투스 파마슈티컬스 인코포레이티드 | 인간 성장 호르몬 결정 및 이것의 제조 방법 |
| ATE492292T2 (de) | 2003-04-02 | 2011-01-15 | Ares Trading Sa | Flüssige oder gefriergetrocknete pharmazeutische zusammensetzung enthaltend fsh und/oder lh, das nichtionische tensid poloxamer 188 und ein antibakterielles mittel |
| JP4871124B2 (ja) | 2003-06-20 | 2012-02-08 | アレス トレーディング ソシエテ アノニム | 凍結乾燥fsh/lh製剤 |
| CA2551510C (en) | 2003-12-23 | 2013-07-30 | Pharmacia Corporation | Stable growth hormone liquid formulation |
| ES2567634T3 (es) | 2004-02-09 | 2016-04-25 | Human Genome Sciences, Inc. | Proteínas de fusión de albúmina |
| AU2005237775B2 (en) * | 2004-04-07 | 2010-03-04 | Ares Trading S.A. | Liquid growth hormone formulation |
| US8334365B2 (en) | 2006-06-07 | 2012-12-18 | Human Genome Sciences, Inc. | Albumin fusion proteins |
| LT2049148T (lt) * | 2006-07-06 | 2016-11-25 | Daewoong Co., Ltd. | Žmogaus augimo hormono skysta stabili kompozicija |
| EP2120869A2 (en) * | 2006-12-18 | 2009-11-25 | Altus Pharmaceuticals Inc. | Human growth hormone formulations |
| JP5766188B2 (ja) | 2009-07-01 | 2015-08-19 | プロチバ バイオセラピューティクス インコーポレイティッド | 固形腫瘍に治療剤を送達するための脂質製剤 |
| BR112012011539A8 (pt) * | 2009-11-17 | 2017-12-26 | Ipsen Pharma Sas | formulação para a combinação de hgh e rhigf-1 |
| WO2011089250A2 (en) | 2010-01-22 | 2011-07-28 | Novo Nordisk Health Care Ag | Stable growth hormone compounds |
| RU2605627C2 (ru) | 2010-01-22 | 2016-12-27 | Ново Нордиск Хелс Кеа Аг | Гормоны роста с пролонгированной эффективностью in vivo |
| WO2012000104A1 (en) | 2010-06-30 | 2012-01-05 | Protiva Biotherapeutics, Inc. | Non-liposomal systems for nucleic acid delivery |
| KR101337797B1 (ko) * | 2010-07-14 | 2013-12-06 | 한미사이언스 주식회사 | 지속형 인간 성장 호르몬 결합체 액상 제제 |
| US20140194356A1 (en) * | 2011-07-25 | 2014-07-10 | Sandoz Ag | Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein |
| US10064951B2 (en) * | 2012-03-30 | 2018-09-04 | Hanmi Science Co., Ltd. | Liquid formulation of highly concentrated long-acting human growth hormone conjugate |
| JP5487276B2 (ja) * | 2012-11-12 | 2014-05-07 | デウン カンパニー,リミテッド | ヒト成長ホルモンを含有する安定した液状製剤 |
| US11045523B2 (en) | 2013-04-05 | 2021-06-29 | Novo Nordisk Healthcare Ag | Formulation of growth hormone albumin-binder conjugate |
| CN113425835B (zh) * | 2020-03-23 | 2024-03-19 | 常州健益生物制药有限公司 | 一种生长激素原料药溶液、水针剂及其制备方法 |
| CN112494638B (zh) * | 2020-12-22 | 2023-12-19 | 深圳科兴药业有限公司 | 一种人生长激素注射剂组合物及其制备方法 |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4783441A (en) | 1979-04-30 | 1988-11-08 | Hoechst Aktiengesellschaft | Aqueous protein solutions stable to denaturation |
| DE3325223A1 (de) * | 1983-07-13 | 1985-01-24 | Hoechst Ag, 6230 Frankfurt | Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung |
| JPS6270319A (ja) | 1985-07-30 | 1987-03-31 | インタ−ナシヨナル・ミネラルズ・アンド・ケミカル・コ−ポレイシヨン | 成長促進ホルモンの安定化 |
| DE3782737T3 (de) * | 1987-08-21 | 1999-05-20 | Imcera Group Inc., Northbrook, Ill. | Stabilisierung von Wachstumshormonen. |
| US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
| US4904043A (en) * | 1988-06-15 | 1990-02-27 | American Telephone And Telegraph Company, At&T Bell Laboratories | Optical data link dual wavelength coupler |
| US5182258A (en) * | 1989-03-20 | 1993-01-26 | Orbon Corporation | Systemic delivery of polypeptides through the eye |
| GB9007052D0 (en) * | 1990-03-29 | 1990-05-30 | Skua Investments Ltd | Pharmaceutical formulations |
| US5126324A (en) * | 1990-06-07 | 1992-06-30 | Genentech, Inc. | Method of enhancing growth in patients using combination therapy |
| US5210017A (en) * | 1990-11-19 | 1993-05-11 | Genentech, Inc. | Ligand-mediated immunofunctional hormone binding protein assay method |
-
1993
- 1993-07-29 CA CA002337745A patent/CA2337745C/en not_active Expired - Lifetime
- 1993-07-29 DK DK93918499T patent/DK0652766T4/da active
- 1993-07-29 WO PCT/US1993/007149 patent/WO1994003198A1/en not_active Ceased
- 1993-07-29 NZ NZ255158A patent/NZ255158A/en not_active IP Right Cessation
- 1993-07-29 EP EP99107148A patent/EP0955062B1/en not_active Revoked
- 1993-07-29 DE DE69329651T patent/DE69329651T3/de not_active Expired - Lifetime
- 1993-07-29 AU AU47927/93A patent/AU686567C/en not_active Expired
- 1993-07-29 IL IL10652493A patent/IL106524A/xx not_active IP Right Cessation
- 1993-07-29 CA CA002489978A patent/CA2489978A1/en not_active Abandoned
- 1993-07-29 DK DK99107148T patent/DK0955062T3/da active
- 1993-07-29 CA CA002139358A patent/CA2139358C/en not_active Expired - Lifetime
- 1993-07-29 ES ES99107148T patent/ES2286868T3/es not_active Expired - Lifetime
- 1993-07-29 MD MD96-0246A patent/MD1699F2/ro unknown
- 1993-07-29 DE DE69334134T patent/DE69334134T2/de not_active Expired - Lifetime
- 1993-07-29 PT PT93918499T patent/PT652766E/pt unknown
- 1993-07-29 AT AT93918499T patent/ATE197405T1/de active
- 1993-07-29 ES ES93918499T patent/ES2153385T5/es not_active Expired - Lifetime
- 1993-07-29 EP EP93918499A patent/EP0652766B2/en not_active Expired - Lifetime
- 1993-07-29 JP JP50543994A patent/JP4018133B2/ja not_active Expired - Lifetime
- 1993-07-29 AT AT99107148T patent/ATE359824T1/de active
- 1993-07-30 MX MX9304613A patent/MX9304613A/es active IP Right Grant
-
2000
- 2000-12-27 GR GR20000402832T patent/GR3035144T3/el unknown
-
2006
- 2006-10-16 JP JP2006280928A patent/JP2007045841A/ja not_active Withdrawn
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration |