HRP20110699T1 - Stabilne tekuće formulacije interferona - Google Patents
Stabilne tekuće formulacije interferona Download PDFInfo
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- 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
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- Prior art keywords
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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
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- 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)
Abstract
Stabilni tekući farmaceutski pripravak koji sadrži interferon beta (IFN-beta) ili njegovu sol naznačen time da je navedena formulacija otopina koja sadrži acetatni pufer, 2-hidroksipropil-beta-ciklodekstrin (HPBCD), manitol i metionin, te pri čemu je navedeni HPBCD prisutan u molarnom omjeru u odnosu na navedeni IFN- beta u 500-strukom molarnom suvišku sve do 700-strukog molarnog suviška. Patent sadrži još 23 patentna zahtjeva.
Claims (24)
1. Stabilni tekući farmaceutski pripravak koji sadrži interferon beta (IFN-beta) ili njegovu sol naznačen time da je navedena formulacija otopina koja sadrži acetatni pufer, 2-hidroksipropil-beta-ciklodekstrin (HPBCD), manitol i metionin, te pri čemu je navedeni HPBCD prisutan u molarnom omjeru u odnosu na navedeni IFN- beta u 500-strukom molarnom suvišku sve do 700-strukog molarnog suviška.
2. Pripravak prema zahtjevu 1, naznačen time da navedeni IFN-beta je rekombinantni ljudski IFN-beta.
3. Pripravak prema zahtjevu 1 ili 2, naznačen time da je navedeni acetatni pufer prisutan u količini dovoljnoj za održavanje pH navedenog pripravka unutar plus ili minus 0.5 jedinica određenog pH, gdje je određeni pH 3 do 6.
4. Pripravak prema zahtjevu 3, naznačen time da je navedeni pH 3.8.
5. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da je navedeni acetatni pufer prisutan u koncentraciji od 5 mM do 500 mM.
6. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da je navedeni acetatni pufer prisutan u koncentraciji od 50 mM.
7. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da je navedeni manitol prisutan u koncentraciji od 0.5 mg/ml do 500 mg/ml.
8. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da je navedeni manitol prisutan u koncentraciji od 50 mg/ml.
9. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da je navedeni metionin prisutan u koncentraciji od 0.01 mg/ml do 5 mg/ml.
10. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da je navedeni metionin prisutan u koncentraciji od 0.1 mg/ml.
11. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da navedeni IFN- beta je prisutan u koncentraciji od 10 μg/ml do 800 μg/ml.
12. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da je navedeni IFN- beta prisutan u koncentraciji od 44,88 ili 276 μg/ml.
13. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da navedeni pripravak je vodena otopina.
14. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da nadalje sadrži bakteriostatsko sredstvo.
15. Pripravak prema zahtjevu 14, naznačen time da je navedeno bakteriostatsko sredstvo benzil alkohol.
16. Pripravak prema zahtjevu 14 ili 15, naznačen time da je navedeno bakteriostatsko sredstvo prisutno u koncentraciji od 0.1% do 2%.
17. Pripravak prema zahtjevu 16, naznačen time da je navedeno bakteriostatsko sredstvo prisutno u koncentraciji od 0.2 ili 0.3%.
18. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da pripravak ima slijedeću tekuću formulaciju:
[image]
19. Postupak za dobivanje stabilnog tekućeg farmaceutskog pripravka prema bilo kojem od zahtjeva 1 do 18, naznačen time da navedeni postupak sadrži dodavanje izračunatih količina 2-hidroksipropil-beta-ciklodekstrina, metionina i manitola u pufersku otopinu i tada se dodaje interferon beta (IFN- beta) ili njegova sol.
20. Hermetički zatvoren spremnik u sterilnim uvjetima i prikladan za čuvanje prije uporabe, naznačen time da sadrži tekuću farmaceutsku formulaciju prema bilo kojem od zahtjeva 1 do 18.
21. Spremnik prema zahtjevu 20, naznačen time da je navedeni spremnik prethodno napunjena injekcija za davanje u jednostrukoj-dozi.
22. Spremnik prema zahtjevu 20, naznačen time da navedeni spremnik je bočica.
23. Spremnik prema zahtjevu 20, naznačen time da je navedeni spremnik uložak za auto-injektor.
24. Spremnik prema bilo kojem od zahtjeva 20 do 23, naznačen time da je navedeni spremnik za davanje u jednostrukoj ili višestrukoj dozi.
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 (hr) |
| EP (1) | EP1691825B1 (hr) |
| JP (1) | JP4658961B2 (hr) |
| AT (1) | ATE526032T1 (hr) |
| AU (1) | AU2004298781B2 (hr) |
| BR (1) | BRPI0416980A (hr) |
| CA (1) | CA2547822A1 (hr) |
| CY (1) | CY1112193T1 (hr) |
| DK (1) | DK1691825T3 (hr) |
| ES (1) | ES2374530T3 (hr) |
| HR (1) | HRP20110699T1 (hr) |
| IL (1) | IL176021A0 (hr) |
| NO (1) | NO20063108L (hr) |
| PL (1) | PL1691825T3 (hr) |
| PT (1) | PT1691825E (hr) |
| RS (1) | RS52218B (hr) |
| SI (1) | SI1691825T1 (hr) |
| WO (1) | WO2005058346A1 (hr) |
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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