CY1112193T1 - Σταθεροποιημενα υγρα σκευασματα ιντερφερονης - Google Patents
Σταθεροποιημενα υγρα σκευασματα ιντερφερονηςInfo
- Publication number
- CY1112193T1 CY1112193T1 CY20111101217T CY111101217T CY1112193T1 CY 1112193 T1 CY1112193 T1 CY 1112193T1 CY 20111101217 T CY20111101217 T CY 20111101217T CY 111101217 T CY111101217 T CY 111101217T CY 1112193 T1 CY1112193 T1 CY 1112193T1
- Authority
- CY
- Cyprus
- Prior art keywords
- interferon
- stabilized liquid
- cyclodextrin
- room temperature
- formulations
- Prior art date
Links
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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Communicable Diseases (AREA)
- Virology (AREA)
- Oncology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
Στην παρούσα περιγράφεται σταθεροποιημένη υγρή φαρμακευτική σύνθεση η οποία περιέχει μια ιντερφερόνη (IFN) ή μια ισόμορφη, μουτεΐνη, συντηγμένη πρωτεΐνη, λειτουργικό παράγωγο, ενεργό θραύσμα ή άλας αυτής, όπου το εν λόγω σκεύασμα είναι ένα διάλυμα το οποίο περιλαμβάνει ένα ρυθμιστικό διάλυμα, μια κυκλοδεξτρίνη, έναν παράγοντα ισοτονικότητας και ένα αντιοξειδωτικό. Κατά προτίμηση, η ιντερφερόνη είναι η ιντερφερόνη-β-1α και η κυκλοδεξτρίνη είναι η HPBCD. Αυτά τα σκευάσματα είναι ευσταθή σε θερμοκρασία δωματίου, επιφέροντας έτσι το πλεονέκτημα του χαμηλότερου κόστους για την αποθήκευση του σκευάσματος και της αυξημένης ασφάλειας για τον ασθενή σε ότι αφορά σε πιθανά «λάθη» κατά το χειρισμό. Είναι γεγονός ότι εάν αυτά τα σκευάσματα είναι ευσταθή σε θερμοκρασία δωματίου μειώνεται ο κίνδυνος σχηματισμού προϊόντος αποικοδόμησης που δυνητικά ευθύνονται για δυσμενείς παρενέργειες (π.χ. ανοσογονικότητα).
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP03104646 | 2003-12-11 | ||
EP04103349 | 2004-07-13 | ||
EP04820468A EP1691825B1 (en) | 2003-12-11 | 2004-12-10 | Stabilized interferon liquid formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
CY1112193T1 true CY1112193T1 (el) | 2015-12-09 |
Family
ID=34702349
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CY20111101217T CY1112193T1 (el) | 2003-12-11 | 2011-12-06 | Σταθεροποιημενα υγρα σκευασματα ιντερφερονης |
Country Status (18)
Country | Link |
---|---|
US (1) | US7846427B2 (el) |
EP (1) | EP1691825B1 (el) |
JP (1) | JP4658961B2 (el) |
AT (1) | ATE526032T1 (el) |
AU (1) | AU2004298781B2 (el) |
BR (1) | BRPI0416980A (el) |
CA (1) | CA2547822A1 (el) |
CY (1) | CY1112193T1 (el) |
DK (1) | DK1691825T3 (el) |
ES (1) | ES2374530T3 (el) |
HR (1) | HRP20110699T1 (el) |
IL (1) | IL176021A0 (el) |
NO (1) | NO20063108L (el) |
PL (1) | PL1691825T3 (el) |
PT (1) | PT1691825E (el) |
RS (1) | RS52218B (el) |
SI (1) | SI1691825T1 (el) |
WO (1) | WO2005058346A1 (el) |
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 |
KR20070012464A (ko) * | 2004-05-17 | 2007-01-25 | 아레스 트레이딩 에스.아. | 하이드로겔 인터페론 제제 |
NZ580686A (en) | 2007-05-02 | 2012-11-30 | Ambrx Inc | Modified interferon beta polypeptides and their uses |
US7951368B2 (en) | 2007-06-25 | 2011-05-31 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
CA2707840A1 (en) | 2007-08-20 | 2009-02-26 | Allozyne, Inc. | Amino acid substituted molecules |
EA201070773A1 (ru) * | 2007-12-20 | 2010-12-30 | Мерк Сероно С. А. | Составы пэг-интерферона-бета |
US20100203014A1 (en) * | 2009-02-04 | 2010-08-12 | Aegis Therapeutics Llc | Zwitterionic buffered acidic peptide and protein formulations |
US20150283252A1 (en) * | 2012-10-26 | 2015-10-08 | Lupin Limited | Stable pharmaceutical composition of peginterferon alpha-2b |
GB201604124D0 (en) * | 2016-03-10 | 2016-04-27 | Ucb Biopharma Sprl | Pharmaceutical formulation |
MX2020007270A (es) * | 2017-09-27 | 2020-08-17 | Novartis Ag | Formulacion parenteral que comprende 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 |
JP2001526033A (ja) * | 1997-12-08 | 2001-12-18 | ジェネンテク・インコーポレイテッド | ヒトインターフェロン−イプシロンというi型インターフェロン |
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 |
KR20070012464A (ko) | 2004-05-17 | 2007-01-25 | 아레스 트레이딩 에스.아. | 하이드로겔 인터페론 제제 |
CN1993139B (zh) | 2004-06-01 | 2011-02-16 | 阿雷斯贸易股份有限公司 | 稳定的干扰素液体制剂 |
-
2004
- 2004-12-10 PT PT04820468T patent/PT1691825E/pt unknown
- 2004-12-10 ES ES04820468T patent/ES2374530T3/es active Active
- 2004-12-10 US US10/582,027 patent/US7846427B2/en active Active
- 2004-12-10 PL PL04820468T patent/PL1691825T3/pl unknown
- 2004-12-10 BR BRPI0416980-8A patent/BRPI0416980A/pt not_active IP Right Cessation
- 2004-12-10 EP EP04820468A patent/EP1691825B1/en active Active
- 2004-12-10 DK DK04820468.9T patent/DK1691825T3/da active
- 2004-12-10 JP JP2006543556A patent/JP4658961B2/ja active Active
- 2004-12-10 SI SI200431761T patent/SI1691825T1/sl unknown
- 2004-12-10 AU AU2004298781A patent/AU2004298781B2/en active Active
- 2004-12-10 RS RS20110581A patent/RS52218B/en unknown
- 2004-12-10 CA CA002547822A patent/CA2547822A1/en not_active Withdrawn
- 2004-12-10 AT AT04820468T patent/ATE526032T1/de 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 |
---|---|
SI1691825T1 (sl) | 2011-12-30 |
PT1691825E (pt) | 2011-10-12 |
PL1691825T3 (pl) | 2012-02-29 |
DK1691825T3 (da) | 2011-12-05 |
IL176021A0 (en) | 2006-10-05 |
US20070104682A1 (en) | 2007-05-10 |
US7846427B2 (en) | 2010-12-07 |
AU2004298781B2 (en) | 2010-04-01 |
JP4658961B2 (ja) | 2011-03-23 |
HRP20110699T1 (hr) | 2011-10-31 |
RS52218B (en) | 2012-10-31 |
EP1691825A1 (en) | 2006-08-23 |
CA2547822A1 (en) | 2005-06-30 |
BRPI0416980A (pt) | 2007-02-21 |
AU2004298781A1 (en) | 2005-06-30 |
NO20063108L (no) | 2006-07-04 |
ATE526032T1 (de) | 2011-10-15 |
JP2007513925A (ja) | 2007-05-31 |
EP1691825B1 (en) | 2011-09-28 |
WO2005058346A1 (en) | 2005-06-30 |
ES2374530T3 (es) | 2012-02-17 |
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