CA2672284C - Human growth hormone formulations - Google Patents
Human growth hormone formulations Download PDFInfo
- Publication number
- CA2672284C CA2672284C CA2672284A CA2672284A CA2672284C CA 2672284 C CA2672284 C CA 2672284C CA 2672284 A CA2672284 A CA 2672284A CA 2672284 A CA2672284 A CA 2672284A CA 2672284 C CA2672284 C CA 2672284C
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- hgh
- crystals
- poly
- suspension
- buffer
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
- A61K47/645—Polycationic or polyanionic oligopeptides, polypeptides or polyamino acids, e.g. polylysine, polyarginine, polyglutamic acid or peptide TAT
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6921—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere
-
- 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
-
- 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
- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Toxicology (AREA)
- Biophysics (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US87060506P | 2006-12-18 | 2006-12-18 | |
| US60/870,605 | 2006-12-18 | ||
| PCT/US2007/087417 WO2008076819A2 (en) | 2006-12-18 | 2007-12-13 | Human growth hormone formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2672284A1 CA2672284A1 (en) | 2008-06-26 |
| CA2672284C true CA2672284C (en) | 2014-08-26 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2672284A Expired - Fee Related CA2672284C (en) | 2006-12-18 | 2007-12-13 | Human growth hormone formulations |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US8071544B2 (enExample) |
| EP (2) | EP2120869A2 (enExample) |
| JP (2) | JP2010513309A (enExample) |
| AU (1) | AU2007333959A1 (enExample) |
| CA (1) | CA2672284C (enExample) |
| DK (1) | DK2486916T3 (enExample) |
| WO (1) | WO2008076819A2 (enExample) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG10201604530SA (en) | 2008-01-22 | 2016-07-28 | Araim Pharmaceuticals Inc | Tissue protective peptides and peptide analogs for preventing and treating diseases and disorders associated with tissue damage |
| TW201023912A (en) | 2008-12-05 | 2010-07-01 | Alcon Res Ltd | Pharmaceutical suspension |
| WO2010101989A1 (en) | 2009-03-03 | 2010-09-10 | Alcon Research, Ltd. | PHARMACEUTICAL COMPOSITION FOR DELIVERY OF RECEPTOR TYROSINE KINASE INHIBITING (RTKi) COMPOUNDS TO THE EYE |
| WO2010115728A2 (en) * | 2009-03-30 | 2010-10-14 | F. Hoffmann-La Roche Ag | A method for avoiding glass fogging |
| EP2453874A2 (en) * | 2009-07-14 | 2012-05-23 | Biogen Idec MA Inc. | Methods for inhibiting yellow color and peroxide formation in a composition |
| EP2473191B1 (en) * | 2009-09-04 | 2017-08-23 | XOMA Technology Ltd. | Antibody coformulations |
| FR2966044B1 (fr) | 2010-10-18 | 2012-11-02 | Sanofi Pasteur | Procede de conditionnement d'un vaccin contenant un adjuvant d'aluminium |
| WO2012125809A1 (en) * | 2011-03-15 | 2012-09-20 | Biogen Idec Inc. | Method for reducing flu-like symptoms associated with intramuscular administration of interferon using a fast titration escalating dosing regimen |
| WO2013014196A1 (en) | 2011-07-25 | 2013-01-31 | Sandoz Ag | Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein |
| EP2782590A4 (en) * | 2011-11-23 | 2016-08-03 | Durect Corp | BIODEGRADABLE AND MEDIUM-RADIATED STERILIZED MEDICAMENTAL COMPOSITIONS |
| EP2949336B1 (en) | 2013-01-28 | 2018-09-05 | National University Corporation Kumamoto University | Stabilized protein gel preparation |
| EP3064213A4 (en) * | 2013-10-28 | 2017-04-26 | Terumo Kabushiki Kaisha | Protein aqueous suspension |
| CN105764491A (zh) | 2013-12-09 | 2016-07-13 | 度瑞公司 | 药物活性剂复合物、聚合物复合物，以及包括其的组合物和方法 |
| 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 (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4342832A (en) | 1979-07-05 | 1982-08-03 | Genentech, Inc. | Method of constructing a replicable cloning vehicle having quasi-synthetic genes |
| US5618697A (en) | 1982-12-10 | 1997-04-08 | Novo Nordisk A/S | Process for preparing a desired protein |
| NL9000634A (nl) * | 1990-03-20 | 1991-10-16 | Catharina Ziekenhuis Stichting | Suspensie-injectiepreparaat op waterbasis, werkwijze voor de bereiding daarvan en toepassing van dit preparaat voor pijnbestrijding. |
| DK168790D0 (enExample) | 1990-07-13 | 1990-07-13 | Novo Nordisk As | |
| ATE227583T1 (de) * | 1991-12-20 | 2002-11-15 | Novo Nordisk As | Stabilisierte pharmazeutische formulierung, die wachstumshormon und histidin enthält |
| ES2153385T5 (es) * | 1992-07-31 | 2008-09-01 | Genentech, Inc. | Composicion acuosa a base de hormona del crecimiento humana. |
| CZ296649B6 (cs) * | 1993-02-23 | 2006-05-17 | Genentech, Inc. | Zpusob výroby stabilizovaného polypeptidového prostredku zahrnující stabilizování polypeptidu protidenaturaci organickými rozpoustedly, jeho príprava a prostredek pro regulované uvolnování polypeptidu |
| US5439643A (en) * | 1993-11-03 | 1995-08-08 | Liebert; Richard T. | Method and apparatus for terminal sterilization |
| JP3829991B2 (ja) * | 1994-06-17 | 2006-10-04 | アプライド リサーチ システムズ エーアールエス ホールディング ナームロゼ ベノートスハップ | Ｈｇｈ含有医薬組成物 |
| US7276251B2 (en) * | 1997-04-01 | 2007-10-02 | Lg Life Sciences, Ltd., Inc. | Sustained-release composition of drugs encapsulated in microparticles of hyaluronic acid |
| US20020077461A1 (en) * | 1996-04-24 | 2002-06-20 | Soren Bjorn | Pharmaceutical formulation |
| US6541606B2 (en) * | 1997-12-31 | 2003-04-01 | Altus Biologics Inc. | Stabilized protein crystals formulations containing them and methods of making them |
| US7582311B1 (en) * | 1999-10-15 | 2009-09-01 | Genentech, Inc. | Injection vehicle for polymer-based formulations |
| CN1606620A (zh) * | 2000-01-28 | 2005-04-13 | 因菲米德治疗有限公司 | 缓慢释放的蛋白质聚合物 |
| BR0317896A (pt) | 2002-12-31 | 2005-12-06 | Altus Pharmaceuticals Inc | Complexos de cristais de proteìna e polìmeros iÈnicos |
| BR0317888A (pt) * | 2002-12-31 | 2005-12-06 | Altus Pharmaceuticals Inc | Cristais do hormÈnio do crescimento humano e processos para preparação dos mesmos |
| US20090023629A1 (en) * | 2005-12-23 | 2009-01-22 | Altus Pharmaceuticals Inc. | Compositions comprising polycation-complexed protein crystals and methods of treatment using them |
-
2007
- 2007-12-13 JP JP2009541592A patent/JP2010513309A/ja active Pending
- 2007-12-13 DK DK11010051.8T patent/DK2486916T3/en active
- 2007-12-13 EP EP07869230A patent/EP2120869A2/en not_active Withdrawn
- 2007-12-13 CA CA2672284A patent/CA2672284C/en not_active Expired - Fee Related
- 2007-12-13 EP EP11010051.8A patent/EP2486916B1/en not_active Not-in-force
- 2007-12-13 WO PCT/US2007/087417 patent/WO2008076819A2/en not_active Ceased
- 2007-12-13 US US12/519,720 patent/US8071544B2/en not_active Expired - Fee Related
- 2007-12-13 AU AU2007333959A patent/AU2007333959A1/en not_active Abandoned
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2011
- 2011-10-10 US US13/270,136 patent/US20120088724A1/en not_active Abandoned
-
2015
- 2015-08-03 JP JP2015153650A patent/JP6106722B2/ja not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| EP2486916B1 (en) | 2015-04-01 |
| US20100216705A1 (en) | 2010-08-26 |
| AU2007333959A1 (en) | 2008-06-26 |
| CA2672284A1 (en) | 2008-06-26 |
| US8071544B2 (en) | 2011-12-06 |
| DK2486916T3 (en) | 2015-06-15 |
| JP6106722B2 (ja) | 2017-04-05 |
| EP2486916A1 (en) | 2012-08-15 |
| WO2008076819A3 (en) | 2009-03-26 |
| US20120088724A1 (en) | 2012-04-12 |
| EP2486916A8 (en) | 2013-03-27 |
| JP2010513309A (ja) | 2010-04-30 |
| WO2008076819A2 (en) | 2008-06-26 |
| EP2120869A2 (en) | 2009-11-25 |
| JP2015214573A (ja) | 2015-12-03 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20201214 |