FI111222B - Förfarande för att framställa en hybrid-alfa-interferonlösning - Google Patents
Förfarande för att framställa en hybrid-alfa-interferonlösning Download PDFInfo
- Publication number
- FI111222B FI111222B FI943705A FI943705A FI111222B FI 111222 B FI111222 B FI 111222B FI 943705 A FI943705 A FI 943705A FI 943705 A FI943705 A FI 943705A FI 111222 B FI111222 B FI 111222B
- Authority
- FI
- Finland
- Prior art keywords
- interferon
- hybrid
- solution
- weeks
- concentration
- 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]
-
- 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
- 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]
- A61K38/212—IFN-alpha
-
- 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
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Peptides Or Proteins (AREA)
Claims (13)
1. Förfarande för att fraraställa en stabil hybrid-α-interferonlösning, kännetecknat därav, att en hybrid-5 α-interferonlösning i ett icke-farmaceutiskt acceptabelt > buffertsystem tas och nämnda buffertsystem byts ut mot ett farmaceutiskt acceptabelt buffertsystem, som är en farmaceutiskt acceptabel buffert med pH 3,0-5,0. 10
2. Förfarande enligt patentkravet 1, kännetecknat därav, att det icke-farmaceutiskt acceptabla buffertsystemet har pH 7.
3. Förfarande enligt patentkravet 1, kännetecknat därav, att den farmaceutiskt acceptabla bufferten är en buffert, som har 15 pH 4,0-4,5.
4. Förfarande enligt nägot av patentkraven 1-3, kännetecknat därav, att bufferten i det farmaceutiskt acceptabla buffertsystemet är glycin/HCl eller natriumcitrat. 20
5. Förfarande enligt nägot av patentkraven 1-4, kännetecknat därav, att bufferten i det farmaceutiskt acceptabla buffertsystemet är i en koncentration av 20-400 mM i lösningen. 25
6. Förfarande enligt patentkravet 4 eller 5, kännetecknat därav, att glycin/HCl är i en koncentration av 50-150 mM i , lösningen. > ··· 30
7. Förfarande enligt nägot av de föregäende patentkraven, kännetecknat därav, att hybrid-a-interferonet är a-interferon BDBB (SEQ ID N0:1). 111222
8. Förfarande enligt nägot av de föregäende patentkraven, kännetecknat därav, att · hybrid-a-interferonet är i en koncentration av 0,1-1,5 mg/ml i lösningen. 5
9. Förfarande enligt nägot av de föregäende patentkraven, kännetecknat därav, att hybrid-a-interferonet är i en koncentration av 0,2-0,4 mg/ml i lösningen.
10. Förfarande enligt nägot av de föregäende patentkraven, 10 kännetecknat därav, att den stabila hybrid- α-interferonlösningen ocksä innehäller en farmaceutiskt acceptabel polyol.
11. Förfarande enligt patentkravet 10, kännetecknat därav, att 15 polyolen är mannitol, sackaros eller glukos.
12. Förfarande enligt patentkravet 10 eller 11, kännetecknat därav, att polyolen är i en koncentration av 20-500 mM i lösningen. 20
13. Förfarande enligt patentkravet 11, kännetecknat därav, att mannitolen är i en koncentration av 100-250 mM i lösningen.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB9316849 | 1993-08-13 | ||
| GB939316849A GB9316849D0 (en) | 1993-08-13 | 1993-08-13 | Pharmaceutical compositions |
| GB9405879A GB9405879D0 (en) | 1994-03-24 | 1994-03-24 | Pharmaceutical compositions |
| GB9405879 | 1994-03-24 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| FI943705A0 FI943705A0 (sv) | 1994-08-10 |
| FI943705A FI943705A (sv) | 1995-02-14 |
| FI111222B true FI111222B (sv) | 2003-06-30 |
Family
ID=26303371
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FI943705A FI111222B (sv) | 1993-08-13 | 1994-08-10 | Förfarande för att framställa en hybrid-alfa-interferonlösning |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US5609868A (sv) |
| EP (1) | EP0641567B1 (sv) |
| JP (1) | JP3745395B2 (sv) |
| KR (1) | KR100351495B1 (sv) |
| AT (1) | ATE190498T1 (sv) |
| AU (1) | AU679233B2 (sv) |
| CA (1) | CA2129921C (sv) |
| CY (1) | CY2230B1 (sv) |
| DE (1) | DE69423402T2 (sv) |
| DK (1) | DK0641567T3 (sv) |
| ES (1) | ES2144034T3 (sv) |
| FI (1) | FI111222B (sv) |
| GR (1) | GR3033239T3 (sv) |
| HU (1) | HU224613B1 (sv) |
| IL (1) | IL110566A (sv) |
| NO (1) | NO315843B1 (sv) |
| NZ (1) | NZ264218A (sv) |
| PT (1) | PT641567E (sv) |
| TW (1) | TW249202B (sv) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020102236A1 (en) * | 1994-12-08 | 2002-08-01 | Taylor Peter William | Liposomal interferon hybrid compositions |
| US20030190307A1 (en) * | 1996-12-24 | 2003-10-09 | Biogen, Inc. | Stable liquid interferon formulations |
| ATE270899T1 (de) * | 1996-12-24 | 2004-07-15 | Biogen Inc | Stabile flüssige interferon-zubereitungen |
| KR19990075253A (ko) * | 1998-03-18 | 1999-10-15 | 성재갑 | 약학적으로 안정한 인터페론 제 |
| US6685933B1 (en) | 1998-07-28 | 2004-02-03 | The United States Of America As Represented By The Department Of Health And Human Services | Interferon α hybrids |
| ES2167189B1 (es) * | 1999-12-17 | 2003-04-01 | Lipotec Sa | Formulacion farmaceutica estable para la administracion intravenosa o intramuscular, de principios activos peptidicos |
| DE60139339D1 (de) | 2000-11-07 | 2009-09-03 | Novartis Vaccines & Diagnostic | Stabilisierte interferonzusammensetzungen |
| US6887462B2 (en) * | 2001-04-09 | 2005-05-03 | Chiron Corporation | HSA-free formulations of interferon-beta |
| AR044302A1 (es) * | 2003-05-13 | 2005-09-07 | Ares Trading Sa | Formulaciones con proteinas liquidas estabilizadas en recipientes farmaceuticos |
| JP5208733B2 (ja) * | 2005-06-29 | 2013-06-12 | イエダ リサーチ アンド デベロップメント カンパニー リミテッド | 組換えインターフェロンα２（ＩＦＮα２）変異体 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS59196823A (ja) * | 1983-04-20 | 1984-11-08 | Sunstar Inc | 皮膚および粘膜の真菌症治療用外用剤 |
| US4855238A (en) * | 1983-12-16 | 1989-08-08 | Genentech, Inc. | Recombinant gamma interferons having enhanced stability and methods therefor |
| PT82249B (en) * | 1985-03-25 | 1988-01-07 | Schering Corp | Process for preparing stable gamma-interferon formulations |
| EP0205404B1 (en) * | 1985-06-11 | 1992-07-15 | Ciba-Geigy Ag | Hybrid interferons |
| US4847079A (en) * | 1985-07-29 | 1989-07-11 | Schering Corporation | Biologically stable interferon compositions comprising thimerosal |
| IL88233A (en) * | 1987-11-03 | 1993-08-18 | Genentech Inc | Gamma interferon formulation |
| EP0331635A3 (en) * | 1988-02-29 | 1990-02-28 | The Board of Regents of the University of Texas System | Preparations for treating bladder cancer |
-
1994
- 1994-07-18 TW TW083106518A patent/TW249202B/zh active
- 1994-08-04 IL IL11056694A patent/IL110566A/xx not_active IP Right Cessation
- 1994-08-05 AU AU68939/94A patent/AU679233B2/en not_active Ceased
- 1994-08-05 JP JP18465494A patent/JP3745395B2/ja not_active Expired - Fee Related
- 1994-08-10 EP EP94305930A patent/EP0641567B1/en not_active Expired - Lifetime
- 1994-08-10 ES ES94305930T patent/ES2144034T3/es not_active Expired - Lifetime
- 1994-08-10 DK DK94305930T patent/DK0641567T3/da active
- 1994-08-10 PT PT94305930T patent/PT641567E/pt unknown
- 1994-08-10 US US08/288,671 patent/US5609868A/en not_active Expired - Lifetime
- 1994-08-10 DE DE69423402T patent/DE69423402T2/de not_active Expired - Fee Related
- 1994-08-10 FI FI943705A patent/FI111222B/sv active
- 1994-08-10 AT AT94305930T patent/ATE190498T1/de not_active IP Right Cessation
- 1994-08-11 CA CA002129921A patent/CA2129921C/en not_active Expired - Fee Related
- 1994-08-11 NZ NZ264218A patent/NZ264218A/en not_active IP Right Cessation
- 1994-08-12 NO NO19942983A patent/NO315843B1/no not_active IP Right Cessation
- 1994-08-12 HU HU9402356A patent/HU224613B1/hu not_active IP Right Cessation
- 1994-08-12 KR KR1019940019883A patent/KR100351495B1/ko not_active IP Right Cessation
-
2000
- 2000-04-14 GR GR20000400921T patent/GR3033239T3/el not_active IP Right Cessation
-
2001
- 2001-07-30 CY CY0100020A patent/CY2230B1/xx unknown
Also Published As
| Publication number | Publication date |
|---|---|
| KR100351495B1 (ko) | 2003-02-19 |
| NO942983L (no) | 1995-02-14 |
| US5609868A (en) | 1997-03-11 |
| HU9402356D0 (en) | 1994-10-28 |
| DK0641567T3 (da) | 2000-08-14 |
| HU224613B1 (hu) | 2005-11-28 |
| FI943705A0 (sv) | 1994-08-10 |
| EP0641567A1 (en) | 1995-03-08 |
| AU6893994A (en) | 1995-02-23 |
| ATE190498T1 (de) | 2000-04-15 |
| PT641567E (pt) | 2000-08-31 |
| DE69423402T2 (de) | 2000-08-03 |
| GR3033239T3 (en) | 2000-09-29 |
| HUT68692A (en) | 1995-07-28 |
| JPH07145070A (ja) | 1995-06-06 |
| TW249202B (sv) | 1995-06-11 |
| FI943705A (sv) | 1995-02-14 |
| NO315843B1 (no) | 2003-11-03 |
| CA2129921A1 (en) | 1995-02-14 |
| ES2144034T3 (es) | 2000-06-01 |
| AU679233B2 (en) | 1997-06-26 |
| EP0641567B1 (en) | 2000-03-15 |
| JP3745395B2 (ja) | 2006-02-15 |
| CY2230B1 (en) | 2003-04-18 |
| DE69423402D1 (de) | 2000-04-20 |
| NZ264218A (en) | 1995-07-26 |
| CA2129921C (en) | 2006-12-05 |
| IL110566A0 (en) | 1995-01-24 |
| NO942983D0 (no) | 1994-08-12 |
| IL110566A (en) | 1999-12-22 |
| KR950005325A (ko) | 1995-03-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GB | Transfer or assigment of application |
Owner name: NOVARTIS AG |