SK282207B6 - Stabilizovaný prípravok s rekombinantným faktorom viii bez albumínu s malým obsahom cukru - Google Patents

Stabilizovaný prípravok s rekombinantným faktorom viii bez albumínu s malým obsahom cukru Download PDF

Info

Publication number: SK282207B6
Authority: SK; Slovakia
Prior art keywords: rfviii; factor viii; formulation; albumin; histidine
Prior art date: 1996-07-12

Application number

SK921-97A

Other languages

English (en)

Slovak (sk)

Other versions

SK92197A3 (en

Inventor

Rajiv Nayar

Original Assignee

Bayer Corporation

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.)

1996-07-12

Filing date

1997-07-04

Publication date

2001-12-03

1997-07-04 Application filed by Bayer Corporation filed Critical Bayer Corporation

1998-02-04 Publication of SK92197A3 publication Critical patent/SK92197A3/sk

2001-12-03 Publication of SK282207B6 publication Critical patent/SK282207B6/sk

Links

229960000301 factor viii Drugs 0.000 title claims abstract description 22
238000002360 preparation method Methods 0.000 title claims description 17
235000000346 sugar Nutrition 0.000 title description 15
108010054218 Factor VIII Proteins 0.000 claims abstract description 21
102000001690 Factor VIII Human genes 0.000 claims abstract description 21
FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 20
DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims abstract description 18
HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims abstract description 17
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
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 abstract description 10
229930006000 Sucrose Natural products 0.000 claims abstract description 10
239000011780 sodium chloride Substances 0.000 claims abstract description 10
239000005720 sucrose Substances 0.000 claims abstract description 10
239000004471 Glycine Substances 0.000 claims abstract description 9
UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims abstract description 8
239000001110 calcium chloride Substances 0.000 claims abstract description 8
229910001628 calcium chloride Inorganic materials 0.000 claims abstract description 8
239000012931 lyophilized formulation Substances 0.000 claims abstract description 6
239000000203 mixture Substances 0.000 abstract description 49
238000009472 formulation Methods 0.000 abstract description 37
239000000047 product Substances 0.000 description 14
235000002639 sodium chloride Nutrition 0.000 description 9
102000009027 Albumins Human genes 0.000 description 8
108010088751 Albumins Proteins 0.000 description 8
238000004108 freeze drying Methods 0.000 description 8
235000018102 proteins Nutrition 0.000 description 8
102000004169 proteins and genes Human genes 0.000 description 8
108090000623 proteins and genes Proteins 0.000 description 8
102100022641 Coagulation factor IX Human genes 0.000 description 7
102100026735 Coagulation factor VIII Human genes 0.000 description 7
108010076282 Factor IX Proteins 0.000 description 7
101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 description 7
229960004222 factor ix Drugs 0.000 description 7
238000000034 method Methods 0.000 description 7
210000002381 plasma Anatomy 0.000 description 6
238000003860 storage Methods 0.000 description 6
230000000694 effects Effects 0.000 description 5
239000007788 liquid Substances 0.000 description 5
235000001014 amino acid Nutrition 0.000 description 4
150000001413 amino acids Chemical class 0.000 description 4
150000008163 sugars Chemical class 0.000 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 description 3
FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 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 description 3
229930195725 Mannitol Natural products 0.000 description 3
230000000368 destabilizing effect Effects 0.000 description 3
239000000594 mannitol Substances 0.000 description 3
235000010355 mannitol Nutrition 0.000 description 3
239000000463 material Substances 0.000 description 3
230000008569 process Effects 0.000 description 3
150000003839 salts Chemical class 0.000 description 3
239000003381 stabilizer Substances 0.000 description 3
230000000087 stabilizing effect Effects 0.000 description 3
239000004475 Arginine Substances 0.000 description 2
238000004458 analytical method Methods 0.000 description 2
ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 2
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 description 2
230000023555 blood coagulation Effects 0.000 description 2
238000004587 chromatography analysis Methods 0.000 description 2
230000015271 coagulation Effects 0.000 description 2
238000005345 coagulation Methods 0.000 description 2
238000011109 contamination Methods 0.000 description 2
238000011026 diafiltration Methods 0.000 description 2
230000003993 interaction Effects 0.000 description 2
230000008018 melting Effects 0.000 description 2
238000002844 melting Methods 0.000 description 2
230000029983 protein stabilization Effects 0.000 description 2
238000000746 purification Methods 0.000 description 2
239000000126 substance Substances 0.000 description 2
230000001225 therapeutic effect Effects 0.000 description 2
238000000108 ultra-filtration Methods 0.000 description 2
HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 1
DBTMGCOVALSLOR-UHFFFAOYSA-N 32-alpha-galactosyl-3-alpha-galactosyl-galactose Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(OC2C(C(CO)OC(O)C2O)O)OC(CO)C1O DBTMGCOVALSLOR-UHFFFAOYSA-N 0.000 description 1
102000015081 Blood Coagulation Factors Human genes 0.000 description 1
108010039209 Blood Coagulation Factors Proteins 0.000 description 1
102000004506 Blood Proteins Human genes 0.000 description 1
108010017384 Blood Proteins Proteins 0.000 description 1
RXVWSYJTUUKTEA-UHFFFAOYSA-N D-maltotriose Natural products OC1C(O)C(OC(C(O)CO)C(O)C(O)C=O)OC(CO)C1OC1C(O)C(O)C(O)C(CO)O1 RXVWSYJTUUKTEA-UHFFFAOYSA-N 0.000 description 1
108010062466 Enzyme Precursors Proteins 0.000 description 1
102000010911 Enzyme Precursors Human genes 0.000 description 1
208000031220 Hemophilia Diseases 0.000 description 1
208000009292 Hemophilia A Diseases 0.000 description 1
HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 1
102000008100 Human Serum Albumin Human genes 0.000 description 1
108091006905 Human Serum Albumin Proteins 0.000 description 1
HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 1
239000004472 Lysine Substances 0.000 description 1
KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
102000035195 Peptidases Human genes 0.000 description 1
108091005804 Peptidases Proteins 0.000 description 1
HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 1
HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 1
239000005557 antagonist Substances 0.000 description 1
230000009286 beneficial effect Effects 0.000 description 1
239000010836 blood and blood product Substances 0.000 description 1
239000003114 blood coagulation factor Substances 0.000 description 1
229940125691 blood product Drugs 0.000 description 1
238000006473 carboxylation reaction Methods 0.000 description 1
239000012141 concentrate Substances 0.000 description 1
239000002178 crystalline material Substances 0.000 description 1
239000008367 deionised water Substances 0.000 description 1
229910021641 deionized water Inorganic materials 0.000 description 1
238000011161 development Methods 0.000 description 1
238000004031 devitrification Methods 0.000 description 1
238000000113 differential scanning calorimetry Methods 0.000 description 1
238000004090 dissolution Methods 0.000 description 1
231100000673 dose–response relationship Toxicity 0.000 description 1
238000001035 drying Methods 0.000 description 1
230000005496 eutectics Effects 0.000 description 1
238000007710 freezing Methods 0.000 description 1
230000008014 freezing Effects 0.000 description 1
238000001502 gel electrophoresis Methods 0.000 description 1
239000011521 glass Substances 0.000 description 1
230000009477 glass transition Effects 0.000 description 1
125000000291 glutamic acid group Chemical group N[C@@H](CCC(O)=O)C(=O)* 0.000 description 1
229960002897 heparin Drugs 0.000 description 1
229920000669 heparin Polymers 0.000 description 1
230000002209 hydrophobic effect Effects 0.000 description 1
238000011534 incubation Methods 0.000 description 1
230000005764 inhibitory process Effects 0.000 description 1
230000000977 initiatory effect Effects 0.000 description 1
102000002467 interleukin receptors Human genes 0.000 description 1
108010093036 interleukin receptors Proteins 0.000 description 1
238000005342 ion exchange Methods 0.000 description 1
150000002500 ions Chemical class 0.000 description 1
239000012669 liquid formulation Substances 0.000 description 1
239000006193 liquid solution Substances 0.000 description 1
230000007774 longterm Effects 0.000 description 1
238000012792 lyophilization process Methods 0.000 description 1
FYGDTMLNYKFZSV-UHFFFAOYSA-N mannotriose Natural products OC1C(O)C(O)C(CO)OC1OC1C(CO)OC(OC2C(OC(O)C(O)C2O)CO)C(O)C1O FYGDTMLNYKFZSV-UHFFFAOYSA-N 0.000 description 1
238000004519 manufacturing process Methods 0.000 description 1
239000011159 matrix material Substances 0.000 description 1
238000009928 pasteurization Methods 0.000 description 1
239000008194 pharmaceutical composition Substances 0.000 description 1
238000012545 processing Methods 0.000 description 1
239000012460 protein solution Substances 0.000 description 1
230000002797 proteolythic effect Effects 0.000 description 1
239000002994 raw material Substances 0.000 description 1
238000011160 research Methods 0.000 description 1
230000004044 response Effects 0.000 description 1
230000035945 sensitivity Effects 0.000 description 1
239000007787 solid Substances 0.000 description 1
239000000243 solution Substances 0.000 description 1
238000001179 sorption measurement Methods 0.000 description 1
230000006641 stabilisation Effects 0.000 description 1
238000011105 stabilization Methods 0.000 description 1
239000007858 starting material Substances 0.000 description 1
239000013589 supplement Substances 0.000 description 1
238000010257 thawing Methods 0.000 description 1
238000013060 ultrafiltration and diafiltration Methods 0.000 description 1
FYGDTMLNYKFZSV-BYLHFPJWSA-N β-1,4-galactotrioside 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]2[C@@H](O[C@@H](O)[C@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O FYGDTMLNYKFZSV-BYLHFPJWSA-N 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
- 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
- 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
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- 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
- A61K47/02—Inorganic compounds
- 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

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Epidemiology (AREA)
Hematology (AREA)
Zoology (AREA)
Gastroenterology & Hepatology (AREA)
Immunology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Diabetes (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Medicinal Preparation (AREA)

SK921-97A 1996-07-12 1997-07-04 Stabilizovaný prípravok s rekombinantným faktorom viii bez albumínu s malým obsahom cukru SK282207B6 (sk)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
US08/678,492 US5763401A (en)	1996-07-12	1996-07-12	Stabilized albumin-free recombinant factor VIII preparation having a low sugar content

Publications (2)

Publication Number	Publication Date
SK92197A3 SK92197A3 (en)	1998-02-04
SK282207B6 true SK282207B6 (sk)	2001-12-03

Family

ID=24723010

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
SK921-97A SK282207B6 (sk)	1996-07-12	1997-07-04	Stabilizovaný prípravok s rekombinantným faktorom viii bez albumínu s malým obsahom cukru

Country Status (30)

Country	Link
US (2)	US5763401A (de)
EP (1)	EP0818204B1 (de)
JP (1)	JP4077055B2 (de)
KR (1)	KR100491281B1 (de)
CN (1)	CN1130224C (de)
AR (1)	AR007845A1 (de)
AT (1)	ATE191146T1 (de)
AU (1)	AU718901B2 (de)
BR (1)	BR9704407B1 (de)
CA (1)	CA2210038C (de)
CO (1)	CO4700302A1 (de)
CZ (1)	CZ292183B6 (de)
DE (1)	DE69701548T2 (de)
DK (1)	DK0818204T3 (de)
ES (1)	ES2144293T3 (de)
GR (1)	GR3033669T3 (de)
HU (1)	HU221415B1 (de)
ID (1)	ID19074A (de)
IL (1)	IL121273A (de)
MY (1)	MY125544A (de)
NZ (1)	NZ328297A (de)
PL (1)	PL186950B1 (de)
PT (1)	PT818204E (de)
RU (1)	RU2201252C2 (de)
SG (1)	SG50864A1 (de)
SK (1)	SK282207B6 (de)
TR (1)	TR199700628A2 (de)
TW (1)	TW381027B (de)
UA (1)	UA43882C2 (de)
ZA (1)	ZA976167B (de)

Families Citing this family (71)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US7560107B2 (en)	1996-06-26	2009-07-14	Emory University	Modified factor VIII
US5763401A (en) *	1996-07-12	1998-06-09	Bayer Corporation	Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
DK1820516T3 (da)	1999-02-22	2013-10-28	Univ Connecticut	Nye albuminfrie faktor VIII-præparater
US20040266673A1 (en) *	2002-07-31	2004-12-30	Peter Bakis	Long lasting natriuretic peptide derivatives
US6887470B1 (en)	1999-09-10	2005-05-03	Conjuchem, Inc.	Protection of endogenous therapeutic peptides from peptidase activity through conjugation to blood components
US7601691B2 (en) *	1999-05-17	2009-10-13	Conjuchem Biotechnologies Inc.	Anti-obesity agents
HK1052876B (en) *	1999-12-30	2006-06-16	Intermune, Inc.	Gamma-ifn liquid-droplet aerosol and method
US6689353B1 (en)	2000-06-28	2004-02-10	Bayer Pharmaceuticals Corporation	Stabilized interleukin 2
EP1458408B1 (de)	2001-12-21	2009-04-15	Novo Nordisk Health Care AG	Flüssige zusammensetzung aus faktor vii polypeptiden
DE10211227A1 (de) *	2002-03-13	2003-10-02	Aventis Behring Gmbh	Verfahren zur Rekonstitution von Iyophilisierten Proteinen
GB0207092D0 (en)	2002-03-26	2002-05-08	Sod Conseils Rech Applic	Stable pharmaceutical composition containing factor VIII
CN1671410B (zh) *	2002-06-21	2010-05-12	诺和诺德医疗保健公司	因子ⅶ多肽的稳定化固体组合物
RU2329823C2 (ru) *	2002-10-29	2008-07-27	Алза Корпорейшн	Стабилизированные твердые полипептидные частицы
AU2003293543A1 (en) *	2002-12-13	2004-07-09	Abgenix, Inc.	System and method for stabilizing antibodies with histidine
GB0304636D0 (en) *	2003-02-28	2003-04-02	Britannia Pharmaceuticals Ltd	Pharmaceutical composition for nasal delivery
WO2005002615A1 (en) *	2003-07-01	2005-01-13	Novo Nordisk Health Care Ag	Liquid, aqueous pharmaceutical composition of factor vii polypeptides
CA2531988C (en)	2003-08-05	2016-06-28	Novo Nordisk A/S	Novel insulin derivatives
CA2538794C (en)	2003-09-12	2016-04-19	Antigenics, Inc.	Vaccine for treatment and prevention of herpes simplex virus infection
EP1685160A1 (de) *	2003-11-10	2006-08-02	Arriva-Prometic Inc.	Trockene rekombinante humane alpha 1-antitrypsin-zusammensetzung
CN1917861B (zh) *	2003-12-19	2012-03-21	诺和诺德医疗保健公司	因子vii多肽的稳定化固体组合物
GB0404586D0 (en) *	2004-03-01	2004-04-07	Britannia Pharmaceuticals Ltd	Improvements in or relating to organic materials
BRPI0509117A (pt) *	2004-03-04	2007-08-28	Wyeth Corp	método de liofilização para melhorar a cristalização de excipientes
HRP20060362A2 (en) *	2004-04-23	2007-03-31	Conjuchem Biotechnologies Inc.	Method for the purification of albumin conjugates
DK1750733T3 (da) *	2004-05-03	2014-01-20	Univ Emory	FREMGANGSMÅDE TIL INDGIVELSE AF SVINE-B-DOMÆNELØS fVIII
KR100624013B1 (ko) *	2004-06-25	2006-09-19	주식회사 녹십자홀딩스	동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
CA2576519C (en) *	2004-08-17	2013-05-21	Regeneron Pharmaceuticals, Inc.	Il-1 antagonist formulations
CN101163506B (zh)	2004-12-27	2012-09-26	巴克斯特国际公司	聚合物-von Willebrand因子偶联物
CN101171033A (zh)	2005-03-04	2008-04-30	戴纳瓦克斯技术公司	包含具免疫刺激序列iss之寡核苷酸的疫苗：其中iss与抗原缀合并通过缓冲条件和其他赋形剂稳定
ES2633574T3 (es)	2005-03-25	2017-09-22	Regeneron Pharmaceuticals, Inc.	Formulaciones de antagonistas de VEGF
US8039432B2 (en) *	2005-11-09	2011-10-18	Conjuchem, Llc	Method of treatment of diabetes and/or obesity with reduced nausea side effect
AU2006318583A1 (en) *	2005-11-22	2007-05-31	Wyeth	Immunoglobulin fusion protein formulations
CN101384623B (zh) *	2005-12-22	2013-07-24	常山凯捷健生物药物研发（河北）有限公司	白蛋白与治疗剂的预成型偶联物的制备方法
ES2371361T3 (es)	2005-12-28	2011-12-30	Novo Nordisk A/S	Composiciones que comprenden una insulina acilada y zinc y método de producción de dichas composiciones.
CA2654510C (en)	2006-06-16	2015-03-17	Regeneron Pharmaceuticals, Inc.	Vegf antagonist formulations suitable for intravitreal administration
RU2324495C1 (ru) *	2006-08-31	2008-05-20	Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации	Способ получения препарата фактора свертывания viii крови человека
PT2101821E (pt) *	2006-12-15	2014-10-03	Baxter Int	Fator conjugado viia-ácido (poli)siálico com prolongamento do tempo de meia vida in vivo
US20090099074A1 (en) *	2007-01-10	2009-04-16	Conjuchem Biotechnologies Inc.	Modulating food intake
CA2683317C (en) *	2007-04-26	2014-12-16	Bayer Healthcare Llc	Stabilization of liquid solutions of recombinant protein for frozen storage
US7879805B2 (en) *	2007-06-01	2011-02-01	Acologix, Inc.	High temperature stable peptide formulation
JP5552046B2 (ja)	2007-06-13	2014-07-16	ノボ・ノルデイスク・エー／エス	インスリン誘導体を含有する薬学的製剤
EP2170268A2 (de) *	2007-06-25	2010-04-07	Amgen, Inc.	Zusammensetzungen von spezifischen bindungsmitteln für den hepatozyten-wachstumsfaktor
GB0715285D0 (en) *	2007-08-06	2007-09-12	Britannia Pharmaceuticals Ltd	Improvements in or relating to powdered medicaments for nasal delivery
MX2011001624A (es)	2008-08-21	2011-03-28	Octapharma Ag	Factor viii y ix humano producido en forma recombinante.
WO2010026186A1 (en) *	2008-09-03	2010-03-11	Octapharma Ag	New protecting compositions for recombinantly produced factor viii
JP4959005B2 (ja)	2008-10-30	2012-06-20	ノボ・ノルデイスク・エー／エス	毎日の注射頻度より少ないインスリン注射での真性糖尿病の治療
MX339060B (es)	2008-11-07	2016-05-09	Baxter Int	Formulaciones del factor viii.
NO2440239T3 (de)	2009-06-09	2018-02-10
US10172949B2 (en)	2009-06-09	2019-01-08	Prolong Pharmaceuticals, LLC	Hemoglobin compositions
US10172950B2 (en)	2009-06-09	2019-01-08	Prolong Pharmaceuticals, LLC	Hemoglobin compositions
EP2359812A1 (de)	2010-01-18	2011-08-24	Cephalon France	Lyophilisierte orale Zusammensetzungen
DK2632478T3 (da)	2010-10-27	2019-10-07	Novo Nordisk As	Behandling af diabetes melitus under anvendelse af insulinindsprøjtninger indgivet med varierende indsprøjtningsintervaller
DK2635297T3 (da)	2010-11-05	2019-05-06	Baxalta GmbH	En ny variant af antihæmofil faktor viii, der har en øget specifik aktivitet
JP5943939B2 (ja) *	2010-12-28	2016-07-05	イー・アイ・デュポン・ドウ・ヌムール・アンド・カンパニーＥ．Ｉ．ＤｕＰｏｎｔＤｅＮｅｍｏｕｒｓＡｎｄＣｏｍｐａｎｙ	フッ素化ポリエステルブレンド糸から製造される布帛
JO3283B1 (ar)	2011-04-26	2018-09-16	Sanofi Sa	تركيب يتضمن أفليبيرسيبت, حمض فولينيك, 5- فلورويوراسيل (5- Fu) وإرينوسيتان (FOLFIRI)
CN102430116A (zh) *	2011-08-19	2012-05-02	上海新兴医药股份有限公司	用于人凝血因子ⅷ制剂的干热处理方法及其稳定剂
EP4122487A1 (de)	2013-03-15	2023-01-25	Bioverativ Therapeutics Inc.	Faktor-viii-polypeptidformulierungen
SG10201803999UA (en) *	2013-03-15	2018-06-28	Bayer Healthcare Llc	Recombinant factor viii formulations
CA2906602A1 (en)	2013-03-15	2014-09-25	Bayer Healthcare Llc	Variant factor viii polypeptides and methods of their production and use
EP2991672A1 (de)	2013-04-30	2016-03-09	Novo Nordisk A/S	Neuartiges verabreichungsschema
US9855319B2 (en)	2014-04-01	2018-01-02	Advantech Bioscience Farmacêutica Ltda	Stabilization of factor VIII without calcium as an excipient
JP2017509659A (ja) *	2014-04-01	2017-04-06	アドヴァンテック・バイオサイエンス・ファルマスーティカ・リミターダ	低糖−低グリシンの安定な第ｖｉｉｉ因子製剤
EA035674B1 (ru)	2014-07-18	2020-07-24	Санофи	Способ определения того, является ли пациент, предположительно страдающий от рака, кандидатом для терапии афлиберцептом
CN106687126B (zh)	2014-08-04	2020-07-28	杰特有限公司	因子viii制剂
EA201792501A1 (ru)	2015-05-13	2018-10-31	Эйдженус Инк.	Вакцины для лечения и профилактики рака
WO2017076967A1 (en) *	2015-11-05	2017-05-11	Novo Nordisk A/S	Fviii formulation
CN106139127B (zh) *	2016-08-05	2020-04-07	无锡药明生物技术股份有限公司	重组凝血因子ⅷ冻干制剂
MA52363A (fr)	2018-04-26	2021-03-03	Agenus Inc	Compositions peptidiques de liaison à une protéine de choc thermique (hsp) et leurs méthodes d'utilisation
US10335464B1 (en)	2018-06-26	2019-07-02	Novo Nordisk A/S	Device for titrating basal insulin
WO2021001522A1 (en)	2019-07-04	2021-01-07	CSL Behring Lengnau AG	A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii
US12343383B2 (en)	2019-07-12	2025-07-01	Novo Nordisk A/S	High concentration insulin formulation
JP2025512143A (ja)	2020-11-09	2025-04-17	武田薬品工業株式会社	酸化ケイ素吸着を使用する血漿からのｆｖｉｉｉの精製

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US4623717A (en) *	1980-03-05	1986-11-18	Miles Laboratories, Inc.	Pasteurized therapeutically active protein compositions
US4440679A (en) *	1980-03-05	1984-04-03	Cutter Laboratories, Inc.	Pasteurized therapeutically active protein compositions
US4847362A (en) *	1985-02-01	1989-07-11	New York University	Method for purifying antihemophilic factor
US4758657A (en) *	1985-07-11	1988-07-19	Armour Pharmaceutical Company	Method of purifying Factor VIII:C
CA1329760C (en) *	1987-10-29	1994-05-24	Ted C. K. Lee	Plasma and recombinant protein formulations in high ionic strength media
US4877608A (en) *	1987-11-09	1989-10-31	Rorer Pharmaceutical Corporation	Pharmaceutical plasma protein formulations in low ionic strength media
DE4001451A1 (de) *	1990-01-19	1991-08-01	Octapharma Ag	Stabile injizierbare loesungen von faktor viii und faktor ix
DE4111393A1 (de) *	1991-04-09	1992-10-15	Behringwerke Ag	Stabilisierte faktor viii-praeparationen
WO1993022336A1 (en) *	1992-04-30	1993-11-11	Alpha Therapeutic Corporation	Improved solubilization and stabilization of factor viii complex
US5288853A (en) *	1992-04-30	1994-02-22	Alpha Therapeutic Corporation	Factor viii purification process
CA2124690C (en) *	1992-10-02	2007-09-11	Thomas Osterberg	Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
SE9301581D0 (sv) *	1993-05-07	1993-05-07	Kabi Pharmacia Ab	Protein formulation
SE504074C2 (sv) *	1993-07-05	1996-11-04	Pharmacia Ab	Proteinberedning för subkutan, intramuskulär eller intradermal administrering
IL113010A (en) *	1994-03-31	1999-10-28	Pharmacia & Upjohn Ab	Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration
SE9501189D0 (sv) *	1995-03-31	1995-03-31	Pharmacia Ab	Protein formulation
US5763401A (en) *	1996-07-12	1998-06-09	Bayer Corporation	Stabilized albumin-free recombinant factor VIII preparation having a low sugar content

1996
- 1996-07-12 US US08/678,492 patent/US5763401A/en not_active Expired - Lifetime
1997
- 1997-06-30 DE DE69701548T patent/DE69701548T2/de not_active Expired - Lifetime
- 1997-06-30 EP EP97110631A patent/EP0818204B1/de not_active Expired - Lifetime
- 1997-06-30 ES ES97110631T patent/ES2144293T3/es not_active Expired - Lifetime
- 1997-06-30 PT PT97110631T patent/PT818204E/pt unknown
- 1997-06-30 DK DK97110631T patent/DK0818204T3/da active
- 1997-06-30 AT AT97110631T patent/ATE191146T1/de active
- 1997-07-04 SK SK921-97A patent/SK282207B6/sk not_active IP Right Cessation
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- 1997-07-07 JP JP19525697A patent/JP4077055B2/ja not_active Expired - Lifetime
- 1997-07-08 AU AU28604/97A patent/AU718901B2/en not_active Expired
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- 1997-07-10 AR ARP970103082A patent/AR007845A1/es active IP Right Grant
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- 1997-07-11 KR KR1019970032300A patent/KR100491281B1/ko not_active Expired - Lifetime
- 1997-07-11 RU RU97111733/14A patent/RU2201252C2/ru active
- 1997-07-11 CN CN97114668A patent/CN1130224C/zh not_active Expired - Lifetime
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- 1997-07-14 BR BRPI9704407-5A patent/BR9704407B1/pt not_active IP Right Cessation
1998
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Also Published As

Publication number	Publication date
AR007845A1 (es)	1999-11-24
HUP9701191A2 (hu)	1999-06-28
HUP9701191A3 (en)	2000-08-28
CZ219497A3 (cs)	1998-01-14
BR9704407B1 (pt)	2010-03-09
SG50864A1 (en)	1998-07-20
US5874408A (en)	1999-02-23
CN1130224C (zh)	2003-12-10
CZ292183B6 (cs)	2003-08-13
KR100491281B1 (ko)	2005-08-05
SK92197A3 (en)	1998-02-04
CN1181974A (zh)	1998-05-20
IL121273A0 (en)	1998-01-04
AU2860497A (en)	1998-01-22
IL121273A (en)	2000-09-28
TR199700628A2 (xx)	1998-01-21
RU2201252C2 (ru)	2003-03-27
ZA976167B (en)	1998-02-02
KR980008241A (ko)	1998-04-30
PL321058A1 (en)	1998-01-19
US5763401A (en)	1998-06-09
DK0818204T3 (da)	2000-07-17
ID19074A (id)	1998-06-11
BR9704407A (pt)	2000-06-06
DE69701548D1 (de)	2000-05-04
PT818204E (pt)	2000-08-31
DE69701548T2 (de)	2000-07-27
UA43882C2 (uk)	2002-01-15
EP0818204B1 (de)	2000-03-29
JPH1067679A (ja)	1998-03-10
GR3033669T3 (en)	2000-10-31
HU9701191D0 (en)	1997-08-28
JP4077055B2 (ja)	2008-04-16
NZ328297A (en)	1999-09-29
TW381027B (en)	2000-02-01
MY125544A (en)	2006-08-30
ES2144293T3 (es)	2000-06-01
PL186950B1 (pl)	2004-04-30
CO4700302A1 (es)	1998-12-29
CA2210038C (en)	2007-03-13
HU221415B1 (en)	2002-09-28
MX9705209A (es)	1998-05-31
AU718901B2 (en)	2000-04-20
ATE191146T1 (de)	2000-04-15
CA2210038A1 (en)	1998-01-12
EP0818204A2 (de)	1998-01-14
EP0818204A3 (de)	1998-02-04

Legal Events

Date	Code	Title	Description
2017-09-04	MK4A	Patent expired	Expiry date: 20170704

Publication	Publication Date	Title
SK282207B6 (sk)	2001-12-03	Stabilizovaný prípravok s rekombinantným faktorom viii bez albumínu s malým obsahom cukru
KR100303872B1 (ko)	2001-11-22	응고인자ⅷ제형을포함하는조성물,이것의제조방법및안정화제로서의계면활성제의사용방법
EP1308170B1 (de)	2008-11-12	Getrocknete Blutfaktorzusammensetzung mit Trehalose
US20010055617A1 (en)	2001-12-27	Method and preparations for stabilizing biological materials by drying methods without freezing
KR20110086583A (ko)	2011-07-28	제8 인자 제형
US20010051603A1 (en)	2001-12-13	Dried blood factor composition comprising trehalose
US8536125B2 (en)	2013-09-17	Stabilization of liquid solutions of recombinant protein for frozen storage
MXPA97005209A (es)	1998-10-23	Preparacion estabilizada de factor viii recombinante, libre de albumina, que tiene un bajo contenido de azucares
AU2013204652B2 (en)	2015-06-18	Stabilization of liquid solutions of recombinant protein for frozen storage
HK1117766A (en)	2009-01-23	Dried blood factor composition stabilised by trehalose