CA1066189A - Preparation d'un produit contenant le facteur antihemophilique, qui passe rapidement en solution - Google Patents

Preparation d'un produit contenant le facteur antihemophilique, qui passe rapidement en solution

Info

Publication number: CA1066189A
Authority: CA; Canada
Prior art keywords: composition; ahf; carbohydrate; amount; weight
Prior art date: 1975-12-22
Legal status (The legal status 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 status listed.): Expired

Application number

CA268,228A

Other languages

English (en)

Inventor

William R. Thomas

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Baxter International Inc

Original Assignee

Baxter Travenol Laboratories Inc

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.)

1975-12-22

Filing date

1976-12-20

Publication date

1979-11-13

1976-10-05 Priority claimed from US05/729,758 external-priority patent/US4089944A/en

1976-12-20 Application filed by Baxter Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc

1979-11-13 Application granted granted Critical

1979-11-13 Publication of CA1066189A publication Critical patent/CA1066189A/fr

Status Expired legal-status Critical Current

Links

239000000203 mixture Substances 0.000 title claims abstract description 50
238000004519 manufacturing process Methods 0.000 title description 2
150000001720 carbohydrates Chemical class 0.000 claims abstract description 50
239000008247 solid mixture Substances 0.000 claims abstract description 23
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 22
238000005063 solubilization Methods 0.000 claims abstract description 12
230000007928 solubilization Effects 0.000 claims abstract description 12
WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 26
239000008121 dextrose Substances 0.000 claims description 25
239000000243 solution Substances 0.000 claims description 23
102000004169 proteins and genes Human genes 0.000 claims description 16
108090000623 proteins and genes Proteins 0.000 claims description 16
238000000034 method Methods 0.000 claims description 15
102000008946 Fibrinogen Human genes 0.000 claims description 14
108010049003 Fibrinogen Proteins 0.000 claims description 14
229940012952 fibrinogen Drugs 0.000 claims description 14
210000002381 plasma Anatomy 0.000 claims description 12
239000012736 aqueous medium Substances 0.000 claims description 7
239000007787 solid Substances 0.000 claims description 7
239000007788 liquid Substances 0.000 claims description 6
230000000694 effects Effects 0.000 claims description 5
238000004108 freeze drying Methods 0.000 claims description 5
GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
239000008101 lactose Substances 0.000 claims description 4
OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 3
GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 3
GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 3
CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 3
229930006000 Sucrose Natural products 0.000 claims description 3
GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims description 3
150000002772 monosaccharides Chemical class 0.000 claims description 3
150000003839 salts Chemical class 0.000 claims description 3
239000005720 sucrose Substances 0.000 claims description 3
WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 claims description 2
229930091371 Fructose Natural products 0.000 claims description 2
239000005715 Fructose Substances 0.000 claims description 2
RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 2
WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 claims description 2
239000007864 aqueous solution Substances 0.000 claims description 2
150000002016 disaccharides Chemical class 0.000 claims description 2
229930182830 galactose Natural products 0.000 claims description 2
239000000463 material Substances 0.000 claims description 2
230000003381 solubilizing effect Effects 0.000 claims description 2
WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 2
102100026735 Coagulation factor VIII Human genes 0.000 abstract description 36
101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 abstract description 36
125000000837 carbohydrate group Chemical group 0.000 abstract 1
230000001225 therapeutic effect Effects 0.000 abstract 1
235000014633 carbohydrates Nutrition 0.000 description 31
235000018102 proteins Nutrition 0.000 description 8
FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 7
238000002360 preparation method Methods 0.000 description 7
239000000047 product Substances 0.000 description 7
239000011780 sodium chloride Substances 0.000 description 5
DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 4
210000004369 blood Anatomy 0.000 description 4
239000008280 blood Substances 0.000 description 4
238000002347 injection Methods 0.000 description 4
239000007924 injection Substances 0.000 description 4
239000002202 Polyethylene glycol Substances 0.000 description 3
229920001223 polyethylene glycol Polymers 0.000 description 3
239000002244 precipitate Substances 0.000 description 3
239000006228 supernatant Substances 0.000 description 3
JOOXCMJARBKPKM-UHFFFAOYSA-N 4-oxopentanoic acid Chemical compound CC(=O)CCC(O)=O JOOXCMJARBKPKM-UHFFFAOYSA-N 0.000 description 2
239000004375 Dextrin Substances 0.000 description 2
229920001353 Dextrin Polymers 0.000 description 2
108010054218 Factor VIII Proteins 0.000 description 2
102000001690 Factor VIII Human genes 0.000 description 2
239000004471 Glycine Substances 0.000 description 2
238000004587 chromatography analysis Methods 0.000 description 2
235000019425 dextrin Nutrition 0.000 description 2
238000004090 dissolution Methods 0.000 description 2
229960000301 factor viii Drugs 0.000 description 2
238000005194 fractionation Methods 0.000 description 2
239000001509 sodium citrate Substances 0.000 description 2
NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 2
239000002904 solvent Substances 0.000 description 2
241000283690 Bos taurus Species 0.000 description 1
PVNIIMVLHYAWGP-UHFFFAOYSA-N Niacin Chemical compound OC(=O)C1=CC=CN=C1 PVNIIMVLHYAWGP-UHFFFAOYSA-N 0.000 description 1
MUPFEKGTMRGPLJ-RMMQSMQOSA-N Raffinose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 MUPFEKGTMRGPLJ-RMMQSMQOSA-N 0.000 description 1
208000037656 Respiratory Sounds Diseases 0.000 description 1
241000220317 Rosa Species 0.000 description 1
208000007536 Thrombosis Diseases 0.000 description 1
MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 description 1
208000027418 Wounds and injury Diseases 0.000 description 1
239000002253 acid Substances 0.000 description 1
238000005349 anion exchange Methods 0.000 description 1
238000003556 assay Methods 0.000 description 1
210000001772 blood platelet Anatomy 0.000 description 1
210000004027 cell Anatomy 0.000 description 1
238000005119 centrifugation Methods 0.000 description 1
150000001875 compounds Chemical class 0.000 description 1
239000012141 concentrate Substances 0.000 description 1
230000006378 damage Effects 0.000 description 1
-1 dextrose Chemical class 0.000 description 1
239000003085 diluting agent Substances 0.000 description 1
239000008103 glucose Substances 0.000 description 1
150000002402 hexoses Chemical class 0.000 description 1
230000000887 hydrating effect Effects 0.000 description 1
208000014674 injury Diseases 0.000 description 1
229960004903 invert sugar Drugs 0.000 description 1
229940040102 levulinic acid Drugs 0.000 description 1
239000012528 membrane Substances 0.000 description 1
QMHLJNFGMZBHIP-UHFFFAOYSA-N oxirane;propane-1,2-diol Chemical compound C1CO1.CC(O)CO QMHLJNFGMZBHIP-UHFFFAOYSA-N 0.000 description 1
239000011148 porous material Substances 0.000 description 1
229940070376 protein Drugs 0.000 description 1
MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 description 1
206010037833 rales Diseases 0.000 description 1
230000000717 retained effect Effects 0.000 description 1
230000000087 stabilizing effect Effects 0.000 description 1
239000008223 sterile water Substances 0.000 description 1
239000000725 suspension Substances 0.000 description 1
150000004043 trisaccharides Chemical class 0.000 description 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
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
- 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
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
- 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

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Animal Behavior & Ethology (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Chemical Kinetics & Catalysis (AREA)
Oil, Petroleum & Natural Gas (AREA)
General Chemical & Material Sciences (AREA)
Molecular Biology (AREA)
Hematology (AREA)
Zoology (AREA)
Gastroenterology & Hepatology (AREA)
Immunology (AREA)
Biochemistry (AREA)
Inorganic Chemistry (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

CA268,228A 1975-12-22 1976-12-20 Preparation d'un produit contenant le facteur antihemophilique, qui passe rapidement en solution Expired CA1066189A (fr)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US64317875A	1975-12-22	1975-12-22
US05/729,758 US4089944A (en)	1975-12-22	1976-10-05	Rapidly solubilized AHF composition and process for preparing same

Publications (1)

Publication Number	Publication Date
CA1066189A true CA1066189A (fr)	1979-11-13

Family

ID=27094202

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
CA268,228A Expired CA1066189A (fr)	1975-12-22	1976-12-20	Preparation d'un produit contenant le facteur antihemophilique, qui passe rapidement en solution

Country Status (7)

Country	Link
JP (1)	JPS5282716A (fr)
AT (1)	AT351158B (fr)
CA (1)	CA1066189A (fr)
DE (1)	DE2653534C2 (fr)
ES (1)	ES454453A1 (fr)
GB (1)	GB1540610A (fr)
MX (1)	MX4730E (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US4186192A (en) *	1978-12-18	1980-01-29	Cutter Laboratories, Inc.	Stabilized immune serum globulin
DE2916711A1 (de) *	1979-04-25	1980-11-06	Behringwerke Ag	Blutgerinnungsfaktoren und verfahren zu ihrer herstellung
DE3432083A1 (de) *	1984-08-31	1986-03-06	Behringwerke Ag, 3550 Marburg	Pasteurisierte, isoagglutininfreie faktor viii-praeparation und verfahren zu ihrer herstellung
HUP9701554D0 (en) *	1997-09-18	1997-11-28	Human Oltoanyagtermeloe Gyogys	Pharmaceutical composition containing plazma proteins

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US2826533A (en) *	1954-03-15	1958-03-11	Cutter Lab	Stable fibrinogen solutions and method for producing same

1976
- 1976-11-25 DE DE19762653534 patent/DE2653534C2/de not_active Expired
- 1976-12-07 MX MX519176U patent/MX4730E/es unknown
- 1976-12-09 GB GB5145376A patent/GB1540610A/en not_active Expired
- 1976-12-20 CA CA268,228A patent/CA1066189A/fr not_active Expired
- 1976-12-21 ES ES454453A patent/ES454453A1/es not_active Expired
- 1976-12-21 JP JP15299476A patent/JPS5282716A/ja active Pending
- 1976-12-22 AT AT956676A patent/AT351158B/de not_active IP Right Cessation

Also Published As

Publication number	Publication date
GB1540610A (en)	1979-02-14
MX4730E (es)	1982-08-24
ATA956676A (de)	1978-12-15
DE2653534A1 (de)	1977-06-30
ES454453A1 (es)	1978-04-01
AT351158B (de)	1979-07-10
JPS5282716A (en)	1977-07-11
DE2653534C2 (de)	1986-08-28

Publication	Publication Date	Title
US4089944A (en)	1978-05-16	Rapidly solubilized AHF composition and process for preparing same
US4478829A (en)	1984-10-23	Pharmaceutical preparation containing purified fibronectin
DE69329795T2 (de)	2001-07-05	Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator
DE3400413C2 (fr)	1992-07-09
DE69432179T3 (de)	2012-01-19	Eine formulierung des gerinnungsfaktors viii
DE69531204T2 (de)	2004-04-22	Formulierungen fuer faktor ix
DE69333928T2 (de)	2006-08-17	Verbesserte solubilisierung und stabilisierung des faktor viii-komplexes
EP0796623B1 (fr)	2005-05-25	Préparation pharmaceutique pour le traitement des maladies de la coagulation sanguine
DE69430745T2 (de)	2002-10-17	Sauerstoff reduzierte wässerige faktor viii-enthaltene lösung
DE69729786T2 (de)	2005-07-14	Hochkonzentrierte, lyophilisierte und flüssige faktor-ix formulierungen
CA1248453A (fr)	1989-01-10	Composes pharmaceutiques contenant des glycosides de l'anthracycline
EP0302754B1 (fr)	1993-11-03	Solution aqueuse stable de thrombine
DE69527966T2 (de)	2003-05-28	Pharmazeutische zubereitung für die subkutane, intramuskuläre oder intradermale verabreichung von faktor viii
US3631018A (en)	1971-12-28	Production of stable high-potency human ahf using polyethylene glycol and glycine to fractionate a cryoprecipitate of ahf concentrate
JP2818898B2 (ja)	1998-10-30	活性に鋭敏な人のプロテインから成る装薬を作用物質として備えている双室注射器
JPS597693B2 (ja)	1984-02-20	抗トロンビン製剤及びその製法
DE69029765T2 (de)	1997-05-15	Stabilisierung von hochgereinigten Proteinen
DE69630291T2 (de)	2004-05-06	Proteinformulierung, die koajulationsfehler viii oder ix in einer saccharose wässriger lösung enthält
EP2258402A2 (fr)	2010-12-08	Composition sèche
US4168303A (en)	1979-09-18	Lyophilized native gamma globulin preparation for intravenous administration
US4085095A (en)	1978-04-18	Clottable fibrinogen free Factor VIII product and process
JPH08245418A (ja)	1996-09-24	安定なトランスグルタミナーゼ製剤およびそれらを製造する方法
US3933996A (en)	1976-01-20	Composition comprising radioactive labeled-fibrinogen and albumin
CH665356A5 (de)	1988-05-13	Pharmazeutische formulierung.
AT405485B (de)	1999-08-25	Eine das vwf-propeptid enthaltende pharmazeutische präparation