WO2016163764A3 - Stabilized preparation of interferon beta variant - Google Patents
Stabilized preparation of interferon beta variant Download PDFInfo
- Publication number
- WO2016163764A3 WO2016163764A3 PCT/KR2016/003632 KR2016003632W WO2016163764A3 WO 2016163764 A3 WO2016163764 A3 WO 2016163764A3 KR 2016003632 W KR2016003632 W KR 2016003632W WO 2016163764 A3 WO2016163764 A3 WO 2016163764A3
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- stabilized
- pharmaceutical preparation
- interferon beta
- beta variant
- poloxamer
- Prior art date
Links
Classifications
-
- 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
- A61K9/08—Solutions
-
- 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]
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/555—Interferons [IFN]
- C07K14/565—IFN-beta
Abstract
The present invention relates to a stabilized pharmaceutical preparation of R27T comprising a human interferon beta variant (R27T), an acetic acid buffer solution, arginine, mannitol, poloxamer 188, and methionine. The stabilized R27T pharmaceutical preparation according to the present invention comprises an acetic acid buffer solution, arginine, mannitol, poloxamer 188, and methionine, and thereby inhibits formation of an aggregate of an R27T protein and enables long-period storage because of an improvement in thermodynamic and structural stability. Thus, it is expected that the stabilized R27T pharmaceutical preparation will be useful in prevention, improvement and treatment of multiple sclerosis, cancer, autoimmune diseases, viral infectious diseases, HIV infectious diseases, hepatitis C, rheumatoid arthritis, etc.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR20150049200 | 2015-04-07 | ||
KR10-2015-0049200 | 2015-04-07 | ||
KR1020160042320A KR101781945B1 (en) | 2015-04-07 | 2016-04-06 | Stabilized Formulations of Interferon beta Mutant |
KR10-2016-0042320 | 2016-04-06 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2016163764A2 WO2016163764A2 (en) | 2016-10-13 |
WO2016163764A3 true WO2016163764A3 (en) | 2016-12-01 |
Family
ID=57072138
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/KR2016/003632 WO2016163764A2 (en) | 2015-04-07 | 2016-04-07 | Stabilized preparation of interferon beta variant |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2016163764A2 (en) |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20060009913A (en) * | 2003-05-13 | 2006-02-01 | 아레스 트레이딩 에스.에이. | Liquid stabilized protein formulations in coated pharmaceutical containers |
KR20060039132A (en) * | 2004-11-02 | 2006-05-08 | 삼성정밀화학 주식회사 | Human interferon-beta mutein |
KR20070030855A (en) * | 2004-06-01 | 2007-03-16 | 아레스 트레이딩 에스.에이. | Method of stabilizing proteins |
KR20100099298A (en) * | 2007-12-20 | 2010-09-10 | 메르크 세로노 에스. 에이. | Peg-interferon-beta formulations |
US20120269770A1 (en) * | 2010-11-22 | 2012-10-25 | Mark Brader | Stable Preserved Compositions of Interferon-Beta |
-
2016
- 2016-04-07 WO PCT/KR2016/003632 patent/WO2016163764A2/en active Application Filing
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20060009913A (en) * | 2003-05-13 | 2006-02-01 | 아레스 트레이딩 에스.에이. | Liquid stabilized protein formulations in coated pharmaceutical containers |
KR20070030855A (en) * | 2004-06-01 | 2007-03-16 | 아레스 트레이딩 에스.에이. | Method of stabilizing proteins |
KR20060039132A (en) * | 2004-11-02 | 2006-05-08 | 삼성정밀화학 주식회사 | Human interferon-beta mutein |
WO2006049423A1 (en) * | 2004-11-02 | 2006-05-11 | Samsung Fine Chemicals Co Ltd | Human interferon-beta mutein |
KR20100099298A (en) * | 2007-12-20 | 2010-09-10 | 메르크 세로노 에스. 에이. | Peg-interferon-beta formulations |
US20120269770A1 (en) * | 2010-11-22 | 2012-10-25 | Mark Brader | Stable Preserved Compositions of Interferon-Beta |
Also Published As
Publication number | Publication date |
---|---|
WO2016163764A2 (en) | 2016-10-13 |
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