NO305585B1 - FremgangsmÕte for fremstillig av et farmas°ytisk preparat av et ikke-glykosylert t-PA-derivat - Google Patents

FremgangsmÕte for fremstillig av et farmas°ytisk preparat av et ikke-glykosylert t-PA-derivat Download PDF

Info

Publication number: NO305585B1
Authority: NO; Norway
Prior art keywords: mmol; acid; pharmaceutical preparation; citrate; preparation according
Prior art date: 1989-12-20

Application number

NO913238A

Other languages

English (en)

Norwegian (no)

Other versions

NO913238L (no

NO913238D0 (no

Inventor

Ulrich Kohnert

Rainer Rudolph

Original Assignee

Boehringer Mannheim Gmbh

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

1989-12-20

Filing date

1991-08-19

Publication date

1999-06-28

1991-08-19 Application filed by Boehringer Mannheim Gmbh filed Critical Boehringer Mannheim Gmbh

1991-08-19 Publication of NO913238L publication Critical patent/NO913238L/no

1991-08-19 Publication of NO913238D0 publication Critical patent/NO913238D0/no

1999-06-28 Publication of NO305585B1 publication Critical patent/NO305585B1/no

Links

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238000004519 manufacturing process Methods 0.000 title claims description 14
KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims abstract description 42
150000001875 compounds Chemical class 0.000 claims abstract description 18
230000002255 enzymatic effect Effects 0.000 claims abstract description 7
XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 claims description 18
CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 16
238000000034 method Methods 0.000 claims description 16
ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 14
239000004475 Arginine Substances 0.000 claims description 13
KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 13
239000000243 solution Substances 0.000 claims description 13
SLXKOJJOQWFEFD-UHFFFAOYSA-N 6-aminohexanoic acid Chemical compound NCCCCCC(O)=O SLXKOJJOQWFEFD-UHFFFAOYSA-N 0.000 claims description 12
ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 12
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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
- A61K38/43—Enzymes; Proenzymes; Derivatives 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- 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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/49—Urokinase; Tissue plasminogen activator
- 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
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino 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
- A61K47/16—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
- 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
- A61K9/0012—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

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Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
Engineering & Computer Science (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
General Health & Medical Sciences (AREA)
Epidemiology (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Oil, Petroleum & Natural Gas (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Bioinformatics & Cheminformatics (AREA)
Immunology (AREA)
Gastroenterology & Hepatology (AREA)
Biomedical Technology (AREA)
Dermatology (AREA)
Biochemistry (AREA)
Molecular Biology (AREA)
Organic Chemistry (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Diabetes (AREA)
Hematology (AREA)
Medicinal Preparation (AREA)
Saccharide Compounds (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Steroid Compounds (AREA)
Finger-Pressure Massage (AREA)
Enzymes And Modification Thereof (AREA)
Soil Conditioners And Soil-Stabilizing Materials (AREA)
Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)

NO913238A 1989-12-20 1991-08-19 FremgangsmÕte for fremstillig av et farmas°ytisk preparat av et ikke-glykosylert t-PA-derivat NO305585B1 (no)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
DE3942141A DE3942141A1 (de)	1989-12-20	1989-12-20	K2p pro-stabilisierung
PCT/EP1990/002250 WO1991008765A1 (de)	1989-12-20	1990-12-19	K2p pro-stabilisierung

Publications (3)

Publication Number	Publication Date
NO913238L NO913238L (no)	1991-08-19
NO913238D0 NO913238D0 (no)	1991-08-19
NO305585B1 true NO305585B1 (no)	1999-06-28

Family

ID=6395924

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
NO913238A NO305585B1 (no)	1989-12-20	1991-08-19	FremgangsmÕte for fremstillig av et farmas°ytisk preparat av et ikke-glykosylert t-PA-derivat

Country Status (14)

Country	Link
US (1)	US5352452A (da)
EP (1)	EP0458950B1 (da)
JP (1)	JPH0660108B2 (da)
KR (1)	KR920700681A (da)
AT (1)	ATE94408T1 (da)
AU (1)	AU625307B2 (da)
CA (1)	CA2046861C (da)
DE (2)	DE3942141A1 (da)
DK (1)	DK0458950T3 (da)
ES (1)	ES2060357T3 (da)
FI (1)	FI95999C (da)
HU (2)	HU216793B (da)
NO (1)	NO305585B1 (da)
WO (1)	WO1991008765A1 (da)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
DE3942141A1 (de) *	1989-12-20	1991-06-27	Boehringer Mannheim Gmbh	K2p pro-stabilisierung
DE3942143A1 (de) *	1989-12-20	1991-06-27	Boehringer Mannheim Gmbh	T-pa pro stabilisierung
JPH06506459A (ja) *	1991-04-16	1994-07-21	ロシュダイアグノスティックスゲーエムベーハー	プラスミノーゲン活性化剤を含有する多重ボーラス投与用医薬パッケージユニット
EP0639202B1 (en) *	1992-04-30	1998-11-25	Cor Therapeutics, Inc.	Stable polypeptide composition
DE4405426A1 (de) *	1994-02-21	1995-08-24	Boehringer Mannheim Gmbh	Pharmazeutisches Präparat enthaltend Plasminogenaktivator (t-PA) oder dessen Derivate
JP2001522814A (ja) *	1997-11-07	2001-11-20	カイロンコーポレイション	増大されたｉｇｆ−ｉ溶解性を提供する組成物
US6767892B1 (en) *	1997-11-07	2004-07-27	Chrion Corporation	Compositions providing for increased IGF-I solubility
US6733985B1 (en) *	1999-05-19	2004-05-11	International Technidyne Corporation	Preparation of stable liquid and dried synthetic prothrombin time reagents
US20060019234A1 (en) *	2004-07-22	2006-01-26	Shanbrom Technologies, Llc	Modern blood banking employing improved cell preservation composition
DE602006020568D1 (de) *	2005-07-02	2011-04-21	Arecor Ltd	Stabile wässrige systeme mit proteinen
GB0700523D0 (en) *	2007-01-11	2007-02-21	Insense Ltd	The Stabilisation Of Proteins

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
JPS5951220A (ja) *	1982-08-02	1984-03-24	Asahi Chem Ind Co Ltd	新規なプラスミノ−ゲン・アクチベ−タ−およびその製法ならびにこれを含有する薬剤
DE3584902D1 (de) *	1984-02-29	1992-01-30	Asahi Chemical Ind	Waessrige loesung eines darin in erhoehter konzentration aufgeloesten gewebe-plasminogen-aktivators und herstellungsverfahren.
ZW14486A1 (en) *	1985-07-29	1986-10-22	Smithkline Beckman Corp	Pharmaceutical dosage unit
DE3687255T2 (de) *	1985-09-10	1993-05-06	Eisai Co Ltd	Einen gewebe-plasminogen-aktivator enthaltende zusammensetzung.
US4777043A (en) *	1985-12-17	1988-10-11	Genentech, Inc.	Stabilized human tissue plasminogen activator compositions
JPH0678241B2 (ja) *	1986-04-02	1994-10-05	エーザイ株式会社	ｔＰＡ医薬組成物
DE3718889A1 (de) *	1987-06-05	1988-12-22	Behringwerke Ag	Verfahren zur herstellung einer loesung hoher spezifischer volumenaktivitaet von einem protein mit gewebe-plasminogenaktivator (t-pa)-aktivitaet, loesung, enthaltend protein mit t-pa-aktivitaet und verwendung der loesung in der human- und veterinaermedizin
US4898826A (en) *	1987-12-10	1990-02-06	Invitron Corporation	Method to solubilize tissue plasminogen activator
AU4187389A (en) *	1988-08-02	1990-03-05	Invitron Corporation	Method for preparing tpa compositions
US4980165A (en) *	1989-01-27	1990-12-25	Genetics Institute, Inc.	Pharmaceutical formulations of plasminogen activator proteins
DE3942143A1 (de) *	1989-12-20	1991-06-27	Boehringer Mannheim Gmbh	T-pa pro stabilisierung
DE3942142A1 (de) *	1989-12-20	1991-06-27	Boehringer Mannheim Gmbh	Stabilisierung von glykosyliertem t-pa
DE3942145A1 (de) *	1989-12-20	1991-06-27	Boehringer Mannheim Gmbh	T-pa-solubilisierung
DE3942144A1 (de) *	1989-12-20	1991-06-27	Boehringer Mannheim Gmbh	Stabilisierung von k1k2p pro
DE3942141A1 (de) *	1989-12-20	1991-06-27	Boehringer Mannheim Gmbh	K2p pro-stabilisierung
JPH0813750B2 (ja) *	1990-03-01	1996-02-14	持田製薬株式会社	経口用トロンビン製剤

1989
- 1989-12-20 DE DE3942141A patent/DE3942141A1/de not_active Withdrawn
1990
- 1990-12-19 DK DK91901736.8T patent/DK0458950T3/da active
- 1990-12-19 DE DE91901736T patent/DE59002760D1/de not_active Expired - Lifetime
- 1990-12-19 US US07/730,938 patent/US5352452A/en not_active Expired - Lifetime
- 1990-12-19 AT AT91901736T patent/ATE94408T1/de not_active IP Right Cessation
- 1990-12-19 HU HU912738A patent/HU216793B/hu unknown
- 1990-12-19 JP JP3502062A patent/JPH0660108B2/ja not_active Expired - Lifetime
- 1990-12-19 CA CA002046861A patent/CA2046861C/en not_active Expired - Lifetime
- 1990-12-19 WO PCT/EP1990/002250 patent/WO1991008765A1/de not_active Ceased
- 1990-12-19 ES ES91901736T patent/ES2060357T3/es not_active Expired - Lifetime
- 1990-12-19 AU AU70443/91A patent/AU625307B2/en not_active Ceased
- 1990-12-19 EP EP91901736A patent/EP0458950B1/de not_active Expired - Lifetime
- 1990-12-19 KR KR1019910700925A patent/KR920700681A/ko not_active Ceased
- 1990-12-19 HU HU912738A patent/HUT59318A/hu unknown
1991
- 1991-08-19 FI FI913908A patent/FI95999C/fi active
- 1991-08-19 NO NO913238A patent/NO305585B1/no not_active IP Right Cessation

Also Published As

Publication number	Publication date
HU216793B (hu)	1999-08-30
NO913238L (no)	1991-08-19
KR920700681A (ko)	1992-08-10
AU625307B2 (en)	1992-07-09
DK0458950T3 (da)	1993-12-27
FI95999C (fi)	1996-04-25
JPH04503683A (ja)	1992-07-02
DE3942141A1 (de)	1991-06-27
HU912738D0 (en)	1992-01-28
JPH0660108B2 (ja)	1994-08-10
DE59002760D1 (de)	1993-10-21
ATE94408T1 (de)	1993-10-15
AU7044391A (en)	1991-07-18
EP0458950A1 (de)	1991-12-04
ES2060357T3 (es)	1994-11-16
CA2046861A1 (en)	1991-06-21
HUT59318A (en)	1992-05-28
FI95999B (fi)	1996-01-15
NO913238D0 (no)	1991-08-19
WO1991008765A1 (de)	1991-06-27
CA2046861C (en)	2001-04-10
FI913908A0 (fi)	1991-08-19
US5352452A (en)	1994-10-04
EP0458950B1 (de)	1993-09-15

Legal Events

Date	Code	Title	Description
2011-01-17	MK1K	Patent expired

Publication	Publication Date	Title
NO305585B1 (no)	1999-06-28	FremgangsmÕte for fremstillig av et farmas°ytisk preparat av et ikke-glykosylert t-PA-derivat
US5747030A (en)	1998-05-05	Pharmaceutical preparation containing plasminogen activators
US5409699A (en)	1995-04-25	Compositions containing glycosylated molecules having human tissue type plasminogen activator enzymatic activity
US5352453A (en)	1994-10-04	Compositions containing non-glycosylated human tissue type plasminogen activator
US5366730A (en)	1994-11-22	Stabilized compositions having human tissue type plasminogen activator enzymatic activity
JPH0273022A (ja)	1990-03-13	組織プラスミノーゲン活性化因子を用いた薬学的製剤
CA2046930C (en)	1997-01-14	Stabilisation of k1k2p pro
NO305582B1 (no)	1999-06-28	FremgangsmÕte for fremstilling av et farmas°ytisk preparat av et protein med t-PA-aktivitet
JPH04503525A (ja)	1992-06-25	グリコシル化されていないｔ―ＰＡ誘導体Ｋ１Ｋ２Ｐｐｒｏの製薬学的製剤および医薬品ならびに該製剤の製造方法