AU2010321225B2 - Formulation for hGH and rhIGF-1 combination - Google Patents
Formulation for hGH and rhIGF-1 combination Download PDFInfo
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- AU2010321225B2 AU2010321225B2 AU2010321225A AU2010321225A AU2010321225B2 AU 2010321225 B2 AU2010321225 B2 AU 2010321225B2 AU 2010321225 A AU2010321225 A AU 2010321225A AU 2010321225 A AU2010321225 A AU 2010321225A AU 2010321225 B2 AU2010321225 B2 AU 2010321225B2
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- 230000003389 potentiating effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000004850 protein–protein interaction Effects 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 239000004627 regenerated cellulose Substances 0.000 description 1
- 230000010076 replication Effects 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 238000001542 size-exclusion chromatography Methods 0.000 description 1
- 230000009645 skeletal growth Effects 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000003381 solubilizing effect Effects 0.000 description 1
- 229960004532 somatropin Drugs 0.000 description 1
- 238000004611 spectroscopical analysis Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000008362 succinate buffer Substances 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 238000011179 visual inspection Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 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
- A61K47/16—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
- 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
-
- 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
- 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
- A61K38/30—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
-
- 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
-
- 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
- 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
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Biochemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US26185909P | 2009-11-17 | 2009-11-17 | |
| US61/261,859 | 2009-11-17 | ||
| PCT/EP2010/006996 WO2011060922A1 (en) | 2009-11-17 | 2010-11-17 | Formulation for hgh and rhigf-1 combination |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2010321225A1 AU2010321225A1 (en) | 2012-06-07 |
| AU2010321225B2 true AU2010321225B2 (en) | 2015-12-03 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2010321225A Ceased AU2010321225B2 (en) | 2009-11-17 | 2010-11-17 | Formulation for hGH and rhIGF-1 combination |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US20120270782A1 (https=) |
| EP (1) | EP2501367B1 (https=) |
| JP (2) | JP6084036B2 (https=) |
| KR (1) | KR101614983B1 (https=) |
| CN (1) | CN102665691B (https=) |
| AU (1) | AU2010321225B2 (https=) |
| BR (1) | BR112012011539A8 (https=) |
| CA (1) | CA2780554C (https=) |
| ES (1) | ES2532007T3 (https=) |
| IN (1) | IN2012DN02861A (https=) |
| MX (1) | MX2012005195A (https=) |
| RU (1) | RU2558821C2 (https=) |
| UA (1) | UA108994C2 (https=) |
| WO (1) | WO2011060922A1 (https=) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008545752A (ja) | 2005-06-02 | 2008-12-18 | テルシカ インコーポレーティッド | 成長障害を処置するための方法 |
| JP6363949B2 (ja) * | 2011-07-25 | 2018-07-25 | サンド アクチェンゲゼルシャフト | 少なくとも中性塩および生物薬学的タンパク質を含む、水性製剤 |
| US9216219B2 (en) | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
| CN104371019B (zh) | 2013-08-13 | 2019-09-10 | 鸿运华宁（杭州）生物医药有限公司 | 一种能与glp-1r特异性结合的抗体及其与glp-1的融合蛋白质 |
| AU2015335743B2 (en) * | 2014-10-23 | 2020-12-24 | Amgen Inc. | Reducing viscosity of pharmaceutical formulations |
| US20190064147A1 (en) * | 2015-01-18 | 2019-02-28 | Biogen Ma Inc. | Formulations and screening of biological therapeutic agents |
| PL3257524T3 (pl) | 2015-02-11 | 2021-03-08 | Gmax Biopharm Llc | Stabilny preparat farmaceutyczny w postaci roztworu białka fuzyjnego przeciwciała przeciwko glp-1r |
| US20190060241A1 (en) * | 2016-04-13 | 2019-02-28 | Medimmune, Llc | Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents |
| US20210087236A1 (en) * | 2016-08-15 | 2021-03-25 | The University Of North Carolina At Chapel Hill | Tardigrade disordered proteins as protein stabilizers |
| EP3522918A1 (en) | 2016-10-06 | 2019-08-14 | Amgen Inc. | Reduced viscosity protein pharmaceutical formulations |
| US10953074B2 (en) * | 2017-01-08 | 2021-03-23 | Richard D. Lippman | Composition and method for improving sensorineural hearing |
| JP7377596B2 (ja) | 2017-02-22 | 2023-11-10 | アムジエン・インコーポレーテツド | 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法 |
| IL297504A (en) * | 2020-04-22 | 2022-12-01 | Code Pharma B V | Pharmaceutical compounds and their antiviral uses |
| EP4228676B1 (en) * | 2020-10-19 | 2025-01-08 | Oak Hill Bio Limited | Compositions suitable for use in neonates |
| GEAP202316350A (en) * | 2021-02-12 | 2023-10-25 | Neuren Pharmaceuticals Ltd | Treatments of prader-willi syndrome |
| WO2023096475A1 (ko) * | 2021-11-26 | 2023-06-01 | 주식회사 제넥신 | Hgh 융합단백질의 고농도 투여 제형 |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1369125A1 (en) * | 1996-05-03 | 2003-12-10 | Genentech, Inc. | Treatment of partial growth hormone insensitivity syndrome |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL71991A (en) | 1983-06-06 | 1994-05-30 | Genentech Inc | Preparation of human FGI and FGE in their processed form through recombinant AND tranology in prokaryotes |
| US5763394A (en) * | 1988-04-15 | 1998-06-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| US5374620A (en) | 1990-06-07 | 1994-12-20 | Genentech, Inc. | Growth-promoting composition and its use |
| US5126324A (en) | 1990-06-07 | 1992-06-30 | Genentech, Inc. | Method of enhancing growth in patients using combination therapy |
| US5681814A (en) * | 1990-06-07 | 1997-10-28 | Genentech, Inc. | Formulated IGF-I Composition |
| SE9201073D0 (sv) * | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
| ES2153385T5 (es) * | 1992-07-31 | 2008-09-01 | Genentech, Inc. | Composicion acuosa a base de hormona del crecimiento humana. |
| EP0805689A1 (en) * | 1995-01-13 | 1997-11-12 | Novo Nordisk A/S | A stabilized pharmaceutical formulation comprising a growth hormone and x-lys |
| US6767892B1 (en) * | 1997-11-07 | 2004-07-27 | Chrion Corporation | Compositions providing for increased IGF-I solubility |
| AU1384799A (en) | 1997-11-07 | 1999-05-31 | Chiron Corporation | Novel igf-i composition and its use |
| ES2300268T3 (es) * | 1999-07-12 | 2008-06-16 | Sandoz Ag | Formulaciones de las hormonas de crecimiento. |
| DE60031999T2 (de) * | 1999-10-04 | 2007-06-06 | Novartis Vaccines and Diagnostics, Inc., Emeryville | Stabilisierte flüssige polypeptid-haltige pharmazeutische zusammensetzungen |
| PT1946776T (pt) * | 2002-02-27 | 2017-03-17 | Immunex Corp | Composição de tnfr-fc estabilizada compreendendo arginina |
| CA2491682A1 (en) * | 2002-07-09 | 2004-01-15 | Sandoz Ag | Liquid formulations with a high concentration of human growth hormone (hgh) comprising glycine |
| JP2008545752A (ja) * | 2005-06-02 | 2008-12-18 | テルシカ インコーポレーティッド | 成長障害を処置するための方法 |
| UA97234C2 (ru) * | 2005-11-01 | 2012-01-25 | Уайєт | Раствор хлорида натрия для восстановления влагосодержания композиции лиофилизированного фактора ix |
| EP2049148B1 (en) * | 2006-07-06 | 2016-09-28 | Daewoong Co., Ltd. | A stable liquid formulation of human growth hormone |
| CN102089319B (zh) * | 2008-05-08 | 2013-11-13 | 味之素株式会社 | 蛋白质的重折叠方法 |
-
2010
- 2010-11-17 KR KR1020127015526A patent/KR101614983B1/ko not_active Expired - Fee Related
- 2010-11-17 EP EP10784450.8A patent/EP2501367B1/en not_active Not-in-force
- 2010-11-17 MX MX2012005195A patent/MX2012005195A/es active IP Right Grant
- 2010-11-17 RU RU2012124985/15A patent/RU2558821C2/ru not_active IP Right Cessation
- 2010-11-17 IN IN2861DEN2012 patent/IN2012DN02861A/en unknown
- 2010-11-17 WO PCT/EP2010/006996 patent/WO2011060922A1/en not_active Ceased
- 2010-11-17 AU AU2010321225A patent/AU2010321225B2/en not_active Ceased
- 2010-11-17 UA UAA201207340A patent/UA108994C2/uk unknown
- 2010-11-17 CN CN201080052050.4A patent/CN102665691B/zh not_active Expired - Fee Related
- 2010-11-17 BR BR112012011539A patent/BR112012011539A8/pt not_active Application Discontinuation
- 2010-11-17 US US13/513,858 patent/US20120270782A1/en not_active Abandoned
- 2010-11-17 ES ES10784450.8T patent/ES2532007T3/es active Active
- 2010-11-17 CA CA2780554A patent/CA2780554C/en not_active Expired - Fee Related
- 2010-11-17 JP JP2012539223A patent/JP6084036B2/ja not_active Expired - Fee Related
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2015
- 2015-10-30 JP JP2015215192A patent/JP6143827B2/ja not_active Expired - Fee Related
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2016
- 2016-09-30 US US15/281,361 patent/US20170143834A1/en not_active Abandoned
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1369125A1 (en) * | 1996-05-03 | 2003-12-10 | Genentech, Inc. | Treatment of partial growth hormone insensitivity syndrome |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2013510893A (ja) | 2013-03-28 |
| HK1175711A1 (en) | 2013-07-12 |
| JP6143827B2 (ja) | 2017-06-07 |
| IN2012DN02861A (https=) | 2015-07-24 |
| BR112012011539A2 (pt) | 2016-06-28 |
| KR20120104251A (ko) | 2012-09-20 |
| BR112012011539A8 (pt) | 2017-12-26 |
| CN102665691A (zh) | 2012-09-12 |
| CA2780554C (en) | 2017-08-15 |
| CN102665691B (zh) | 2015-05-27 |
| MX2012005195A (es) | 2012-06-12 |
| RU2558821C2 (ru) | 2015-08-10 |
| EP2501367A1 (en) | 2012-09-26 |
| US20170143834A1 (en) | 2017-05-25 |
| RU2012124985A (ru) | 2013-12-27 |
| ES2532007T3 (es) | 2015-03-23 |
| CA2780554A1 (en) | 2011-05-26 |
| KR101614983B1 (ko) | 2016-04-22 |
| UA108994C2 (uk) | 2015-07-10 |
| JP2016020395A (ja) | 2016-02-04 |
| AU2010321225A1 (en) | 2012-06-07 |
| US20120270782A1 (en) | 2012-10-25 |
| WO2011060922A1 (en) | 2011-05-26 |
| EP2501367B1 (en) | 2015-01-21 |
| JP6084036B2 (ja) | 2017-02-22 |
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