IL102775A - Human protein-containing preserved pharmaceutical preparations in multidosage form for infusion or injection purposes and the production thereof - Google Patents

Human protein-containing preserved pharmaceutical preparations in multidosage form for infusion or injection purposes and the production thereof

Info

Publication number: IL102775A
Authority: IL; Israel
Prior art keywords: preparation; solution; preservative; concentration; present
Prior art date: 1991-08-15

Application number

IL10277592A

Other languages

English (en)

Other versions

IL102775A0 (en

Original Assignee

Roche Diagnostics 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.)

1991-08-15

Filing date

1992-08-10

Publication date

1999-12-22

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=6438353&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=IL102775(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

1992-08-10 Application filed by Roche Diagnostics Gmbh filed Critical Roche Diagnostics Gmbh

1993-01-31 Publication of IL102775A0 publication Critical patent/IL102775A0/xx

1999-12-22 Publication of IL102775A publication Critical patent/IL102775A/en

Links

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OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 claims description 43
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125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
238000001704 evaporation Methods 0.000 description 1
230000002349 favourable effect Effects 0.000 description 1
239000012467 final product Substances 0.000 description 1
238000007710 freezing Methods 0.000 description 1
230000008014 freezing Effects 0.000 description 1
ZDXPYRJPNDTMRX-UHFFFAOYSA-N glutamine Natural products OC(=O)C(N)CCC(N)=O ZDXPYRJPNDTMRX-UHFFFAOYSA-N 0.000 description 1
229960002743 glutamine Drugs 0.000 description 1
230000013595 glycosylation Effects 0.000 description 1
238000006206 glycosylation reaction Methods 0.000 description 1
238000010438 heat treatment Methods 0.000 description 1
XLYOFNOQVPJJNP-UHFFFAOYSA-M hydroxide Chemical compound [OH-] XLYOFNOQVPJJNP-UHFFFAOYSA-M 0.000 description 1
230000000415 inactivating effect Effects 0.000 description 1
238000003780 insertion Methods 0.000 description 1
230000037431 insertion Effects 0.000 description 1
229940079322 interferon Drugs 0.000 description 1
238000011835 investigation Methods 0.000 description 1
210000003734 kidney Anatomy 0.000 description 1
239000008101 lactose Substances 0.000 description 1
239000001630 malic acid Substances 0.000 description 1
235000011090 malic acid Nutrition 0.000 description 1
239000000594 mannitol Substances 0.000 description 1
235000010355 mannitol Nutrition 0.000 description 1
239000011159 matrix material Substances 0.000 description 1
125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
150000007522 mineralic acids Chemical class 0.000 description 1
238000002156 mixing Methods 0.000 description 1
229910000403 monosodium phosphate Inorganic materials 0.000 description 1
235000019799 monosodium phosphate Nutrition 0.000 description 1
230000008693 nausea Effects 0.000 description 1
230000007935 neutral effect Effects 0.000 description 1
229910052757 nitrogen Inorganic materials 0.000 description 1
229920001542 oligosaccharide Polymers 0.000 description 1
150000002482 oligosaccharides Chemical class 0.000 description 1
150000007524 organic acids Chemical class 0.000 description 1
229960003104 ornithine Drugs 0.000 description 1
230000036407 pain Effects 0.000 description 1
229940021222 peritoneal dialysis isotonic solution Drugs 0.000 description 1
230000000144 pharmacologic effect Effects 0.000 description 1
239000013612 plasmid Substances 0.000 description 1
229920001223 polyethylene glycol Polymers 0.000 description 1
239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
229920000136 polysorbate Polymers 0.000 description 1
229950008882 polysorbate Drugs 0.000 description 1
229940068977 polysorbate 20 Drugs 0.000 description 1
229920000053 polysorbate 80 Polymers 0.000 description 1
229940068968 polysorbate 80 Drugs 0.000 description 1
239000001267 polyvinylpyrrolidone Substances 0.000 description 1
229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
159000000001 potassium salts Chemical class 0.000 description 1
238000004321 preservation Methods 0.000 description 1
125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
150000003856 quaternary ammonium compounds Chemical class 0.000 description 1
239000002994 raw material Substances 0.000 description 1
230000009257 reactivity Effects 0.000 description 1
230000009467 reduction Effects 0.000 description 1
210000002966 serum Anatomy 0.000 description 1
230000035939 shock Effects 0.000 description 1
238000004904 shortening Methods 0.000 description 1
AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
229940074545 sodium dihydrogen phosphate dihydrate Drugs 0.000 description 1
239000001488 sodium phosphate Substances 0.000 description 1
229910000162 sodium phosphate Inorganic materials 0.000 description 1
238000001694 spray drying Methods 0.000 description 1
230000003019 stabilising effect Effects 0.000 description 1
238000011146 sterile filtration Methods 0.000 description 1
238000004659 sterilization and disinfection Methods 0.000 description 1
229960005202 streptokinase Drugs 0.000 description 1
238000000859 sublimation Methods 0.000 description 1
230000008022 sublimation Effects 0.000 description 1
239000005720 sucrose Substances 0.000 description 1
229960000187 tissue plasminogen activator Drugs 0.000 description 1
230000009466 transformation Effects 0.000 description 1
210000002700 urine Anatomy 0.000 description 1
229960005356 urokinase Drugs 0.000 description 1
238000001262 western blot Methods 0.000 description 1
238000009736 wetting Methods 0.000 description 1
239000000080 wetting agent Substances 0.000 description 1

Classifications

- 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
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
- 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
- A61K38/18—Growth factors; Growth regulators
- A61K38/1816—Erythropoietin [EPO]
- 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
- A61K38/193—Colony stimulating factors [CSF]
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- 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
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/827—Proteins from mammals or birds
- Y10S530/829—Blood

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Chemical & Material Sciences (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Oil, Petroleum & Natural Gas (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Zoology (AREA)
Gastroenterology & Hepatology (AREA)
Bioinformatics & Cheminformatics (AREA)
Immunology (AREA)
Dermatology (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Medicinal Preparation (AREA)
Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Peptides Or Proteins (AREA)

IL10277592A 1991-08-15 1992-08-10 Human protein-containing preserved pharmaceutical preparations in multidosage form for infusion or injection purposes and the production thereof IL102775A (en)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
DE4126983A DE4126983A1 (de)	1991-08-15	1991-08-15	Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke

Publications (2)

Publication Number	Publication Date
IL102775A0 IL102775A0 (en)	1993-01-31
IL102775A true IL102775A (en)	1999-12-22

Family

ID=6438353

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
IL10277592A IL102775A (en)	1991-08-15	1992-08-10	Human protein-containing preserved pharmaceutical preparations in multidosage form for infusion or injection purposes and the production thereof

Country Status (25)

Country	Link
US (2)	US5503827A (ja)
EP (2)	EP0528313A1 (ja)
JP (1)	JP3670660B2 (ja)
KR (1)	KR100263282B1 (ja)
AT (1)	ATE145138T1 (ja)
AU (2)	AU678756B2 (ja)
CA (1)	CA2115348C (ja)
CZ (1)	CZ284853B6 (ja)
DE (2)	DE4126983A1 (ja)
DK (1)	DK0607156T3 (ja)
ES (1)	ES2094923T3 (ja)
FI (1)	FI112169B (ja)
GE (1)	GEP19981289B (ja)
GR (1)	GR3022037T3 (ja)
HU (1)	HU227421B1 (ja)
IL (1)	IL102775A (ja)
MX (1)	MX9204636A (ja)
NO (1)	NO309844B1 (ja)
RU (1)	RU2091068C1 (ja)
SG (1)	SG66226A1 (ja)
SK (1)	SK281910B6 (ja)
TW (1)	TW351677B (ja)
UA (1)	UA26343C2 (ja)
WO (1)	WO1993003744A1 (ja)
ZA (1)	ZA926122B (ja)

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RU2234942C2 (ru) *	1998-07-14	2004-08-27	Корикса Корпорейшн	Выделенный опухолевый полипептид предстательной железы и кодирующий его полинуклеотид
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JP2003520777A (ja)	1999-07-22	2003-07-08	アベンティス・ファーマスーティカルズ・インコーポレイテツド	防腐医薬製剤
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EP1506786B1 (en) *	2002-05-21	2016-11-23	Daiichi Sankyo Company, Limited	Medicinal compositions containing ghrelin
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1991
- 1991-08-15 DE DE4126983A patent/DE4126983A1/de not_active Withdrawn
1992
- 1992-08-05 TW TW081106209A patent/TW351677B/zh not_active IP Right Cessation
- 1992-08-10 KR KR1019940700453A patent/KR100263282B1/ko not_active Expired - Lifetime
- 1992-08-10 AU AU24094/92A patent/AU678756B2/en not_active Expired
- 1992-08-10 DK DK92916938.1T patent/DK0607156T3/da active
- 1992-08-10 JP JP50407293A patent/JP3670660B2/ja not_active Expired - Lifetime
- 1992-08-10 WO PCT/EP1992/001822 patent/WO1993003744A1/de not_active Ceased
- 1992-08-10 HU HU9400416A patent/HU227421B1/hu unknown
- 1992-08-10 UA UA94005433A patent/UA26343C2/uk unknown
- 1992-08-10 CA CA002115348A patent/CA2115348C/en not_active Expired - Lifetime
- 1992-08-10 SG SG1996001887A patent/SG66226A1/en unknown
- 1992-08-10 EP EP92113571A patent/EP0528313A1/de active Pending
- 1992-08-10 RU RU9294016163A patent/RU2091068C1/ru active
- 1992-08-10 ES ES92916938T patent/ES2094923T3/es not_active Expired - Lifetime
- 1992-08-10 AT AT92916938T patent/ATE145138T1/de active
- 1992-08-10 DE DE59207523T patent/DE59207523C5/de not_active Expired - Lifetime
- 1992-08-10 EP EP92916938A patent/EP0607156B1/de not_active Expired - Lifetime
- 1992-08-10 CZ CZ94287A patent/CZ284853B6/cs not_active IP Right Cessation
- 1992-08-10 IL IL10277592A patent/IL102775A/en not_active IP Right Cessation
- 1992-08-10 SK SK148-94A patent/SK281910B6/sk not_active IP Right Cessation
- 1992-08-10 US US08/193,002 patent/US5503827A/en not_active Expired - Lifetime
- 1992-08-11 MX MX9204636A patent/MX9204636A/es unknown
- 1992-08-14 ZA ZA926122A patent/ZA926122B/xx unknown
- 1992-10-15 GE GEAP19923057A patent/GEP19981289B/en unknown
1994
- 1994-02-14 NO NO940499A patent/NO309844B1/no not_active IP Right Cessation
- 1994-02-14 FI FI940674A patent/FI112169B/fi not_active IP Right Cessation
1996
- 1996-01-30 US US08/593,579 patent/US6303113B1/en not_active Expired - Fee Related
- 1996-12-13 GR GR960403464T patent/GR3022037T3/el unknown
1997
- 1997-03-17 AU AU16339/97A patent/AU710768B2/en not_active Expired

Also Published As

Publication number	Publication date
CZ28794A3 (en)	1994-08-17
SK14894A3 (en)	1994-11-09
US6303113B1 (en)	2001-10-16
HUT67379A (en)	1995-04-28
GR3022037T3 (en)	1997-03-31
EP0607156B1 (de)	1996-11-13
RU94016163A (ru)	1996-08-10
AU678756B2 (en)	1997-06-12
IL102775A0 (en)	1993-01-31
AU710768B2 (en)	1999-09-30
DE59207523C5 (de)	2006-11-16
UA26343C2 (uk)	1999-08-30
FI940674L (fi)	1994-02-14
TW351677B (en)	1999-02-01
KR100263282B1 (ko)	2000-08-01
US5503827A (en)	1996-04-02
NO309844B1 (no)	2001-04-09
FI940674A0 (fi)	1994-02-14
NO940499D0 (no)	1994-02-14
EP0607156A1 (de)	1994-07-27
ATE145138T1 (de)	1996-11-15
NO940499L (no)	1994-02-14
CZ284853B6 (cs)	1999-03-17
DK0607156T3 (da)	1997-04-07
CA2115348C (en)	2007-07-17
AU1633997A (en)	1997-05-22
SG66226A1 (en)	1999-07-20
JP3670660B2 (ja)	2005-07-13
AU2409492A (en)	1993-03-16
MX9204636A (es)	1993-02-01
RU2091068C1 (ru)	1997-09-27
HU9400416D0 (en)	1994-05-30
DE59207523D1 (de)	1996-12-19
HU227421B1 (en)	2011-05-30
CA2115348A1 (en)	1993-03-04
SK281910B6 (sk)	2001-09-11
JPH06510031A (ja)	1994-11-10
WO1993003744A1 (de)	1993-03-04
ES2094923T3 (es)	1997-02-01
GEP19981289B (en)	1998-05-01
DE4126983A1 (de)	1993-02-18
ZA926122B (en)	1994-02-14
FI112169B (fi)	2003-11-14
EP0528313A1 (de)	1993-02-24

Legal Events

Date	Code	Title
2000-06-01	FF	Patent granted
2000-08-31	KB	Patent renewed
2001-06-14	KB	Patent renewed
2013-03-24	EXP	Patent expired

Publication	Publication Date	Title
IL102775A (en)	1999-12-22	Human protein-containing preserved pharmaceutical preparations in multidosage form for infusion or injection purposes and the production thereof
KR960009929B1 (ko)	1996-07-25	안정화된 에리트로포이에틴제제
EP0904099B1 (en)	2005-11-16	Pharmaceutical formulation containing human growth hormone, histidine and a non-ionic detergent
Österberg et al.	1997	Development of a freeze-dried albumin-free formulation of recombinant factor VIII SQ
EP1180368B1 (en)	2007-04-18	Freeze dried hgf preparations
US5691312A (en)	1997-11-25	Pharmaceutical for subcutaneous or intramuscular administration containing polypeptides
IL117405A (en)	2002-05-23	Stable preparations of transglutaminase and processes for their preparation
RU2191029C2 (ru)	2002-10-20	Композиция стабилизированного гормона роста и способ ее приготовления
US8841252B2 (en)	2014-09-23	Pharmaceutical formulation
JPH10507182A (ja)	1998-07-14	成長ホルモンおよびイソロイシンを含んでなる医薬製剤
JPH08333277A (ja)	1996-12-17	ヒト血液凝固第ｘｉｉｉ因子の安定化された水性液製剤
AU742494B2 (en)	2002-01-03	A one dose syringe, comprising a freeze-dried protein composition, for administering of a volume less than 0.5 ml
KR20030016426A (ko)	2003-02-26	Ｎ-[ｏ-(ｐ-피발로일옥시벤젠술포닐아미노)벤조일]글리신·모노나트륨염·4수화물의 동결 건조 제제 및 그 제조 방법
US5552385A (en)	1996-09-03	Pharmaceutical formulation
US20030162711A1 (en)	2003-08-28	Pharmaceutical formulation
WO2000051626A1 (en)	2000-09-08	Chemically modified g-csf preparations
JPWO2000051626A1 (ja)	2002-06-11	化学修飾ｇ−ｃｓｆ製剤