HRP20110699T1 - Stabilne tekuće formulacije interferona - Google Patents
Stabilne tekuće formulacije interferona Download PDFInfo
- Publication number
- HRP20110699T1 HRP20110699T1 HR20110699T HRP20110699T HRP20110699T1 HR P20110699 T1 HRP20110699 T1 HR P20110699T1 HR 20110699 T HR20110699 T HR 20110699T HR P20110699 T HRP20110699 T HR P20110699T HR P20110699 T1 HRP20110699 T1 HR P20110699T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation according
- present
- beta
- concentration
- container
- Prior art date
Links
- 239000012669 liquid formulation Substances 0.000 title claims 2
- 108010050904 Interferons Proteins 0.000 title abstract 4
- 102000014150 Interferons Human genes 0.000 title abstract 4
- 229940079322 interferon Drugs 0.000 title abstract 4
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract 5
- 238000009472 formulation Methods 0.000 claims abstract 5
- 239000000203 mixture Substances 0.000 claims abstract 5
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims abstract 5
- 239000007788 liquid Substances 0.000 claims abstract 4
- 150000003839 salts Chemical class 0.000 claims abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract 2
- 102000003996 Interferon-beta Human genes 0.000 claims 7
- 108090000467 Interferon-beta Proteins 0.000 claims 7
- 229960001388 interferon-beta Drugs 0.000 claims 7
- 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 claims 4
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 4
- 229930195725 Mannitol Natural products 0.000 claims 4
- 239000008351 acetate buffer Substances 0.000 claims 4
- 239000000022 bacteriostatic agent Substances 0.000 claims 4
- 235000010355 mannitol Nutrition 0.000 claims 4
- 239000000594 mannitol Substances 0.000 claims 4
- 229930182817 methionine Natural products 0.000 claims 4
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical group OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims 3
- 238000000034 method Methods 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 101001054334 Homo sapiens Interferon beta Proteins 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 229940090047 auto-injector Drugs 0.000 claims 1
- 235000019445 benzyl alcohol Nutrition 0.000 claims 1
- 239000007853 buffer solution Substances 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 abstract 2
- 108010005716 Interferon beta-1a Proteins 0.000 abstract 1
- 102000001708 Protein Isoforms Human genes 0.000 abstract 1
- 108010029485 Protein Isoforms Proteins 0.000 abstract 1
- 230000002411 adverse Effects 0.000 abstract 1
- 239000003963 antioxidant agent Substances 0.000 abstract 1
- 230000003078 antioxidant effect Effects 0.000 abstract 1
- 235000006708 antioxidants Nutrition 0.000 abstract 1
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000007857 degradation product Substances 0.000 abstract 1
- 230000005847 immunogenicity Effects 0.000 abstract 1
- 229960004461 interferon beta-1a Drugs 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
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
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/215—IFN-beta
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Virology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP03104646 | 2003-12-11 | ||
EP04103349 | 2004-07-13 | ||
PCT/EP2004/053407 WO2005058346A1 (en) | 2003-12-11 | 2004-12-10 | Stabilized interferon liquid formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20110699T1 true HRP20110699T1 (hr) | 2011-10-31 |
Family
ID=34702349
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HR20110699T HRP20110699T1 (hr) | 2003-12-11 | 2011-09-30 | Stabilne tekuće formulacije interferona |
Country Status (18)
Country | Link |
---|---|
US (1) | US7846427B2 (sl) |
EP (1) | EP1691825B1 (sl) |
JP (1) | JP4658961B2 (sl) |
AT (1) | ATE526032T1 (sl) |
AU (1) | AU2004298781B2 (sl) |
BR (1) | BRPI0416980A (sl) |
CA (1) | CA2547822A1 (sl) |
CY (1) | CY1112193T1 (sl) |
DK (1) | DK1691825T3 (sl) |
ES (1) | ES2374530T3 (sl) |
HR (1) | HRP20110699T1 (sl) |
IL (1) | IL176021A0 (sl) |
NO (1) | NO20063108L (sl) |
PL (1) | PL1691825T3 (sl) |
PT (1) | PT1691825E (sl) |
RS (1) | RS52218B (sl) |
SI (1) | SI1691825T1 (sl) |
WO (1) | WO2005058346A1 (sl) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI272948B (en) * | 2003-05-01 | 2007-02-11 | Ares Trading Sa | HSA-free stabilized interferon liquid formulations |
ZA200609412B (en) * | 2004-05-17 | 2008-07-30 | Ares Trading Sa | Hydrogel interferon formulations |
BRPI0810622A2 (pt) | 2007-05-02 | 2020-10-13 | Ambrx, Inc. | polipeptídeos de interferon beta modificados e seus usos |
JP5513380B2 (ja) | 2007-06-25 | 2014-06-04 | アムジエン・インコーポレーテツド | 肝細胞増殖因子に対する特異的結合剤の組成物 |
CA2707840A1 (en) | 2007-08-20 | 2009-02-26 | Allozyne, Inc. | Amino acid substituted molecules |
SI2234645T1 (sl) * | 2007-12-20 | 2012-07-31 | Merck Serono Sa | Formulacije peg interferon beta |
US20100203014A1 (en) * | 2009-02-04 | 2010-08-12 | Aegis Therapeutics Llc | Zwitterionic buffered acidic peptide and protein formulations |
WO2014064652A2 (en) * | 2012-10-26 | 2014-05-01 | Lupin Limited | Stable pharmaceutical composition of peginterferon alpha-2b |
GB201604124D0 (en) * | 2016-03-10 | 2016-04-27 | Ucb Biopharma Sprl | Pharmaceutical formulation |
BR112020005703A2 (pt) * | 2017-09-27 | 2020-10-20 | Novartis Ag | formulação parentérica compreendendo siponimod |
CN111494611A (zh) * | 2020-06-08 | 2020-08-07 | 长春生物制品研究所有限责任公司 | 一种卡式瓶多剂量笔式注射组合包装的干扰素注射液 |
CN113797317B (zh) * | 2021-10-26 | 2024-01-09 | 科兴生物制药股份有限公司 | 一种组合物及其制备方法和应用 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5997856A (en) * | 1988-10-05 | 1999-12-07 | Chiron Corporation | Method and compositions for solubilization and stabilization of polypeptides, especially proteins |
US6582728B1 (en) * | 1992-07-08 | 2003-06-24 | Inhale Therapeutic Systems, Inc. | Spray drying of macromolecules to produce inhaleable dry powders |
US5814485A (en) * | 1995-06-06 | 1998-09-29 | Chiron Corporation | Production of interferon-β (IFN-β) in E. coli |
ZA9610374B (en) * | 1995-12-11 | 1997-06-23 | Elan Med Tech | Cartridge-based drug delivery device |
CA2311681A1 (en) * | 1997-12-08 | 1999-06-17 | Genentech, Inc. | Human interferon-epsilon: a type i interferon |
US6887462B2 (en) * | 2001-04-09 | 2005-05-03 | Chiron Corporation | HSA-free formulations of interferon-beta |
WO2003002152A2 (en) | 2001-06-29 | 2003-01-09 | Maxygen Aps | Stabilized formulations of interferons with sulfoalkyl ether cyclodextrins |
TWI272948B (en) * | 2003-05-01 | 2007-02-11 | Ares Trading Sa | HSA-free stabilized interferon liquid formulations |
ZA200609412B (en) * | 2004-05-17 | 2008-07-30 | Ares Trading Sa | Hydrogel interferon formulations |
US7731948B2 (en) | 2004-06-01 | 2010-06-08 | Ares Trading S.A. | Stabilized interferon liquid formulations |
-
2004
- 2004-12-10 JP JP2006543556A patent/JP4658961B2/ja active Active
- 2004-12-10 AT AT04820468T patent/ATE526032T1/de active
- 2004-12-10 EP EP04820468A patent/EP1691825B1/en active Active
- 2004-12-10 CA CA002547822A patent/CA2547822A1/en not_active Withdrawn
- 2004-12-10 SI SI200431761T patent/SI1691825T1/sl unknown
- 2004-12-10 ES ES04820468T patent/ES2374530T3/es active Active
- 2004-12-10 BR BRPI0416980-8A patent/BRPI0416980A/pt not_active IP Right Cessation
- 2004-12-10 PT PT04820468T patent/PT1691825E/pt unknown
- 2004-12-10 US US10/582,027 patent/US7846427B2/en active Active
- 2004-12-10 PL PL04820468T patent/PL1691825T3/pl unknown
- 2004-12-10 DK DK04820468.9T patent/DK1691825T3/da active
- 2004-12-10 RS RS20110581A patent/RS52218B/en unknown
- 2004-12-10 AU AU2004298781A patent/AU2004298781B2/en active Active
- 2004-12-10 WO PCT/EP2004/053407 patent/WO2005058346A1/en active Application Filing
-
2006
- 2006-05-30 IL IL176021A patent/IL176021A0/en active IP Right Grant
- 2006-07-04 NO NO20063108A patent/NO20063108L/no not_active Application Discontinuation
-
2011
- 2011-09-30 HR HR20110699T patent/HRP20110699T1/hr unknown
- 2011-12-06 CY CY20111101217T patent/CY1112193T1/el unknown
Also Published As
Publication number | Publication date |
---|---|
ATE526032T1 (de) | 2011-10-15 |
PT1691825E (pt) | 2011-10-12 |
EP1691825B1 (en) | 2011-09-28 |
EP1691825A1 (en) | 2006-08-23 |
WO2005058346A1 (en) | 2005-06-30 |
AU2004298781B2 (en) | 2010-04-01 |
CA2547822A1 (en) | 2005-06-30 |
CY1112193T1 (el) | 2015-12-09 |
DK1691825T3 (da) | 2011-12-05 |
SI1691825T1 (sl) | 2011-12-30 |
US20070104682A1 (en) | 2007-05-10 |
IL176021A0 (en) | 2006-10-05 |
PL1691825T3 (pl) | 2012-02-29 |
JP2007513925A (ja) | 2007-05-31 |
ES2374530T3 (es) | 2012-02-17 |
BRPI0416980A (pt) | 2007-02-21 |
NO20063108L (no) | 2006-07-04 |
RS52218B (en) | 2012-10-31 |
JP4658961B2 (ja) | 2011-03-23 |
US7846427B2 (en) | 2010-12-07 |
AU2004298781A1 (en) | 2005-06-30 |
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