BRPI0416980A - formulações lìquidas de interferon estabilizadas - Google Patents
formulações lìquidas de interferon estabilizadasInfo
- Publication number
- BRPI0416980A BRPI0416980A BRPI0416980-8A BRPI0416980A BRPI0416980A BR PI0416980 A BRPI0416980 A BR PI0416980A BR PI0416980 A BRPI0416980 A BR PI0416980A BR PI0416980 A BRPI0416980 A BR PI0416980A
- Authority
- BR
- Brazil
- Prior art keywords
- interferon
- formulations
- cyclodextrin
- room temperature
- stable
- Prior art date
Links
- 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
- 239000012669 liquid formulation Substances 0.000 title 1
- 238000009472 formulation Methods 0.000 abstract 4
- 239000000203 mixture Substances 0.000 abstract 4
- 229920000858 Cyclodextrin Polymers 0.000 abstract 3
- 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
- 239000007788 liquid Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 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 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)
- 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)
- Inorganic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Communicable Diseases (AREA)
- Virology (AREA)
- Oncology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
"FORMULAçõES LìQUIDAS DE INTERFERON ESTABILIZADAS". São descritos aqui composição farmacêutica líquida estabilizada compreendendo um interferon (IFN) ou uma isoforma, muteína, proteína fundida, derivado funcional, fração ativa ou sal dos mesmos, em que a referida formulação é uma solução que compreende um tampão, uma ciclodextrina, um agente de isotonicidade e um anti-oxidante. Preferencialmente o interferon é interferon beta-1a e a ciclodextrina é HPBCD. Estas formulações são estáveis em temperatura ambiente, deste modo trazendo a vantagem de menores custos para armazenamento da formulação e aumento da segurança para o paciente com respeito a possíveis 'erros' durante o manuseio. De fato, o fato de ter semelhantes formulações estáveis em temperatura ambiente reduz o risco de formação de produtos de degradação potencialmente responsáveis por eventos adversos (por exemplo, imunogenicidade).
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 |
|---|---|
| BRPI0416980A true BRPI0416980A (pt) | 2007-02-21 |
Family
ID=34702349
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0416980-8A BRPI0416980A (pt) | 2003-12-11 | 2004-12-10 | formulações lìquidas de interferon estabilizadas |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US7846427B2 (pt) |
| EP (1) | EP1691825B1 (pt) |
| JP (1) | JP4658961B2 (pt) |
| AT (1) | ATE526032T1 (pt) |
| AU (1) | AU2004298781B2 (pt) |
| BR (1) | BRPI0416980A (pt) |
| CA (1) | CA2547822A1 (pt) |
| CY (1) | CY1112193T1 (pt) |
| DK (1) | DK1691825T3 (pt) |
| ES (1) | ES2374530T3 (pt) |
| HR (1) | HRP20110699T1 (pt) |
| IL (1) | IL176021A0 (pt) |
| NO (1) | NO20063108L (pt) |
| PL (1) | PL1691825T3 (pt) |
| PT (1) | PT1691825E (pt) |
| RS (1) | RS52218B (pt) |
| SI (1) | SI1691825T1 (pt) |
| WO (1) | WO2005058346A1 (pt) |
Families Citing this family (13)
| 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 |
| WO2007130453A2 (en) | 2006-05-02 | 2007-11-15 | Allozyne, Inc. | Non-natural amino acid substituted polypeptides |
| EP2076533B1 (en) | 2007-05-02 | 2014-10-08 | Ambrx, Inc. | Modified interferon beta polypeptides and their uses |
| WO2009002521A2 (en) | 2007-06-25 | 2008-12-31 | 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 |
| ES2387236T3 (es) * | 2007-12-20 | 2012-09-18 | Merck Serono S.A. | Formulaciones de interferón beta pegilado |
| US20100203014A1 (en) * | 2009-02-04 | 2010-08-12 | Aegis Therapeutics Llc | Zwitterionic buffered acidic peptide and protein formulations |
| KR20150074167A (ko) * | 2012-10-26 | 2015-07-01 | 루핀 리미티드 | Ｐｅｇ 인터페론 알파-2ｂ의 안정한 약학 조성물 |
| GB201604124D0 (en) * | 2016-03-10 | 2016-04-27 | Ucb Biopharma Sprl | Pharmaceutical formulation |
| AU2018341136A1 (en) | 2017-09-27 | 2020-03-12 | Novartis Ag | Parenteral formulation comprising 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 |
| JP2004522803A (ja) * | 2001-06-29 | 2004-07-29 | マキシゲン・エイピーエス | インターフェロン製剤 |
| 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 |
| EP1750751B1 (en) | 2004-06-01 | 2013-04-10 | Ares Trading S.A. | Stabilized interferon liquid formulations |
-
2004
- 2004-12-10 US US10/582,027 patent/US7846427B2/en active Active
- 2004-12-10 BR BRPI0416980-8A patent/BRPI0416980A/pt not_active IP Right Cessation
- 2004-12-10 SI SI200431761T patent/SI1691825T1/sl unknown
- 2004-12-10 PL PL04820468T patent/PL1691825T3/pl unknown
- 2004-12-10 ES ES04820468T patent/ES2374530T3/es not_active Expired - Lifetime
- 2004-12-10 EP EP04820468A patent/EP1691825B1/en not_active Expired - Lifetime
- 2004-12-10 PT PT04820468T patent/PT1691825E/pt unknown
- 2004-12-10 AT AT04820468T patent/ATE526032T1/de active
- 2004-12-10 JP JP2006543556A patent/JP4658961B2/ja not_active Expired - Lifetime
- 2004-12-10 CA CA002547822A patent/CA2547822A1/en not_active Withdrawn
- 2004-12-10 WO PCT/EP2004/053407 patent/WO2005058346A1/en not_active Ceased
- 2004-12-10 HR HR20110699T patent/HRP20110699T1/hr unknown
- 2004-12-10 AU AU2004298781A patent/AU2004298781B2/en not_active Expired
- 2004-12-10 DK DK04820468.9T patent/DK1691825T3/da active
- 2004-12-10 RS RS20110581A patent/RS52218B/sr unknown
-
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
- 2011-12-06 CY CY20111101217T patent/CY1112193T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PT1691825E (pt) | 2011-10-12 |
| ATE526032T1 (de) | 2011-10-15 |
| EP1691825A1 (en) | 2006-08-23 |
| HRP20110699T1 (hr) | 2011-10-31 |
| AU2004298781A1 (en) | 2005-06-30 |
| JP4658961B2 (ja) | 2011-03-23 |
| US20070104682A1 (en) | 2007-05-10 |
| AU2004298781B2 (en) | 2010-04-01 |
| US7846427B2 (en) | 2010-12-07 |
| ES2374530T3 (es) | 2012-02-17 |
| CA2547822A1 (en) | 2005-06-30 |
| RS52218B (sr) | 2012-10-31 |
| EP1691825B1 (en) | 2011-09-28 |
| IL176021A0 (en) | 2006-10-05 |
| PL1691825T3 (pl) | 2012-02-29 |
| SI1691825T1 (sl) | 2011-12-30 |
| NO20063108L (no) | 2006-07-04 |
| DK1691825T3 (da) | 2011-12-05 |
| WO2005058346A1 (en) | 2005-06-30 |
| JP2007513925A (ja) | 2007-05-31 |
| CY1112193T1 (el) | 2015-12-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: REFERENTE A 9A ANUIDADE. |
|
| B08K | Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette] |
Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2260 DE 29/04/2014. |