SK285668B6 - Spôsob výroby jednodávkovej striekačky obsahujúcej lyofilizovaný proteín na podávanie objemu menšieho ako 0,5 ml - Google Patents

Spôsob výroby jednodávkovej striekačky obsahujúcej lyofilizovaný proteín na podávanie objemu menšieho ako 0,5 ml Download PDF

Info

Publication number: SK285668B6
Authority: SK; Slovakia
Prior art keywords: chamber; protein; cake; volume; weight
Prior art date: 1997-11-28

Application number

SK720-2000A

Other languages

English (en)

Slovak (sk)

Other versions

SK7202000A3 (en

Inventor

Karin Limrell

Ebba Florin-Robertsson

Elvy H�Kby

Ulf Nilsson

Anders Str�M

Original Assignee

Pharmacia & Upjohn Ab

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.)

1997-11-28

Filing date

1998-11-19

Publication date

2007-06-07

1998-11-19 Application filed by Pharmacia & Upjohn Ab filed Critical Pharmacia & Upjohn Ab

2001-05-10 Publication of SK7202000A3 publication Critical patent/SK7202000A3/sk

2007-06-07 Publication of SK285668B6 publication Critical patent/SK285668B6/sk

Links

102000004169 proteins and genes Human genes 0.000 title claims abstract description 27
108090000623 proteins and genes Proteins 0.000 title claims abstract description 27
238000004519 manufacturing process Methods 0.000 title claims abstract description 7
238000000034 method Methods 0.000 title claims abstract 10
150000001413 amino acids Chemical class 0.000 claims abstract description 13
239000000203 mixture Substances 0.000 claims abstract description 10
239000003381 stabilizer Substances 0.000 claims abstract description 10
DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 30
FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 21
229930195725 Mannitol Natural products 0.000 claims description 21
239000000594 mannitol Substances 0.000 claims description 21
235000010355 mannitol Nutrition 0.000 claims description 21
239000004471 Glycine Substances 0.000 claims description 15
108010000521 Human Growth Hormone Proteins 0.000 claims description 10
102000002265 Human Growth Hormone Human genes 0.000 claims description 10
239000000854 Human Growth Hormone Substances 0.000 claims description 10
239000000872 buffer Substances 0.000 claims description 9
102000018997 Growth Hormone Human genes 0.000 claims description 7
108010051696 Growth Hormone Proteins 0.000 claims description 7
239000000122 growth hormone Substances 0.000 claims description 6
229910000162 sodium phosphate Inorganic materials 0.000 claims description 6
239000001488 sodium phosphate Substances 0.000 claims description 6
RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 6
239000003795 chemical substances by application Substances 0.000 claims description 3
239000000243 solution Substances 0.000 abstract description 14
239000007864 aqueous solution Substances 0.000 abstract 1
238000001035 drying Methods 0.000 abstract 1
235000018102 proteins Nutrition 0.000 description 19
235000001014 amino acid Nutrition 0.000 description 8
238000009472 formulation Methods 0.000 description 6
238000002347 injection Methods 0.000 description 6
239000007924 injection Substances 0.000 description 6
235000011008 sodium phosphates Nutrition 0.000 description 4
BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 3
229910000397 disodium phosphate Inorganic materials 0.000 description 3
235000019800 disodium phosphate Nutrition 0.000 description 3
108010006025 bovine growth hormone Proteins 0.000 description 2
230000009172 bursting Effects 0.000 description 2
238000005336 cracking Methods 0.000 description 2
238000004108 freeze drying Methods 0.000 description 2
238000002523 gelfiltration Methods 0.000 description 2
239000011159 matrix material Substances 0.000 description 2
238000002360 preparation method Methods 0.000 description 2
239000000126 substance Substances 0.000 description 2
QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 description 1
241001465754 Metazoa Species 0.000 description 1
239000002253 acid Substances 0.000 description 1
150000007513 acids Chemical class 0.000 description 1
235000004279 alanine Nutrition 0.000 description 1
239000003708 ampul Substances 0.000 description 1
239000013011 aqueous formulation Substances 0.000 description 1
230000015556 catabolic process Effects 0.000 description 1
238000006731 degradation reaction Methods 0.000 description 1
CSVGEMRSDNSWRF-UHFFFAOYSA-L disodium;dihydrogen phosphate Chemical compound [Na+].[Na+].OP(O)([O-])=O.OP(O)([O-])=O CSVGEMRSDNSWRF-UHFFFAOYSA-L 0.000 description 1
239000003814 drug Substances 0.000 description 1
238000002474 experimental method Methods 0.000 description 1
229940063135 genotropin Drugs 0.000 description 1
229940102223 injectable solution Drugs 0.000 description 1
239000000644 isotonic solution Substances 0.000 description 1
239000007788 liquid Substances 0.000 description 1
239000012931 lyophilized formulation Substances 0.000 description 1
239000008176 lyophilized powder Substances 0.000 description 1
239000000463 material Substances 0.000 description 1
125000001360 methionine group Chemical group N[C@@H](CCSC)C(=O)* 0.000 description 1
239000002736 nonionic surfactant Substances 0.000 description 1
208000003068 pituitary dwarfism Diseases 0.000 description 1
239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
229920000053 polysorbate 80 Polymers 0.000 description 1
229940068968 polysorbate 80 Drugs 0.000 description 1
239000000843 powder Substances 0.000 description 1
239000003755 preservative agent Substances 0.000 description 1
230000002335 preservative effect Effects 0.000 description 1
238000000746 purification Methods 0.000 description 1
239000002904 solvent Substances 0.000 description 1
238000003860 storage Methods 0.000 description 1
239000004094 surface-active agent Substances 0.000 description 1
230000008961 swelling Effects 0.000 description 1
208000011580 syndromic disease Diseases 0.000 description 1
230000001225 therapeutic effect Effects 0.000 description 1
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
- 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
- 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
- A61K38/22—Hormones
- A61K38/27—Growth hormone [GH], i.e. somatotropin
- 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
- A61K9/14—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)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Animal Behavior & Ethology (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Endocrinology (AREA)
Oil, Petroleum & Natural Gas (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Zoology (AREA)
Molecular Biology (AREA)
Biochemistry (AREA)
Gastroenterology & Hepatology (AREA)
Bioinformatics & Cheminformatics (AREA)
Immunology (AREA)
Dermatology (AREA)
Biomedical Technology (AREA)
Anesthesiology (AREA)
Vascular Medicine (AREA)
Heart & Thoracic Surgery (AREA)
Hematology (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Medicinal Preparation (AREA)
Infusion, Injection, And Reservoir Apparatuses (AREA)
Materials For Medical Uses (AREA)
Polysaccharides And Polysaccharide Derivatives (AREA)
Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Peptides Or Proteins (AREA)
Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

SK720-2000A 1997-11-28 1998-11-19 Spôsob výroby jednodávkovej striekačky obsahujúcej lyofilizovaný proteín na podávanie objemu menšieho ako 0,5 ml SK285668B6 (sk)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
SE9704405A SE9704405D0 (sv)	1997-11-28	1997-11-28	New syringe
PCT/SE1998/002096 WO1999027983A1 (en)	1997-11-28	1998-11-19	A ONE DOSE SYRINGE, COMPRISING A FREEZE-DRIED PROTEIN COMPOSITION, FOR ADMINISTERING OF A VOLUME LESS THAN 0.5 ml

Publications (2)

Publication Number	Publication Date
SK7202000A3 SK7202000A3 (en)	2001-05-10
SK285668B6 true SK285668B6 (sk)	2007-06-07

Family

ID=20409182

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
SK720-2000A SK285668B6 (sk)	1997-11-28	1998-11-19	Spôsob výroby jednodávkovej striekačky obsahujúcej lyofilizovaný proteín na podávanie objemu menšieho ako 0,5 ml

Country Status (24)

Country	Link
US (1)	US6152897A (ko)
EP (1)	EP1034007B1 (ko)
JP (1)	JP4564652B2 (ko)
KR (1)	KR100567358B1 (ko)
CN (1)	CN1156315C (ko)
AT (1)	ATE354390T1 (ko)
AU (1)	AU742494B2 (ko)
CA (1)	CA2311754C (ko)
CY (1)	CY1106403T1 (ko)
CZ (1)	CZ300255B6 (ko)
DE (1)	DE69837159T2 (ko)
DK (1)	DK1034007T3 (ko)
ES (1)	ES2281142T3 (ko)
HK (1)	HK1032920A1 (ko)
HU (1)	HUP0004410A3 (ko)
MX (1)	MXPA00005214A (ko)
NO (1)	NO324692B1 (ko)
NZ (1)	NZ505150A (ko)
PL (1)	PL193243B1 (ko)
PT (1)	PT1034007E (ko)
RU (1)	RU2214285C2 (ko)
SE (1)	SE9704405D0 (ko)
SK (1)	SK285668B6 (ko)
WO (1)	WO1999027983A1 (ko)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US20060157507A1 (en) *	2004-12-30	2006-07-20	Chang Byeong S	Multi-functional container closure delivery system
US7959600B2 (en)	2004-12-30	2011-06-14	Byeong S. Chang	Container closure delivery system
US20060144869A1 (en) *	2004-12-30	2006-07-06	Chang Byeong S	Container closure delivery system
US8062254B2 (en) *	2008-01-08	2011-11-22	MacLean, LLC	Spring driven adjustable oral syringe
CA2824390C (en)	2011-01-10	2016-03-08	Byeong Seon Chang	Compact medication reconstitution device and method
GB2498774A (en)	2012-01-27	2013-07-31	Bruce Roser	Glass-stabilised biological materials and syringe
KR102276304B1 (ko)	2013-09-27	2021-07-14	한미약품 주식회사	지속형 인간 성장 호르몬 제제
CN106999349A (zh)	2014-09-09	2017-08-01	拜昂·塞翁·常	溶液输送设备和方法
WO2018101358A1 (ja) *	2016-11-29	2018-06-07	Ｓｐｉｂｅｒ株式会社	タンパク質組成物、その製造方法及び熱安定性向上方法
CN108498467B (zh) *	2018-05-21	2019-03-05	中山未名海济生物医药有限公司	注射用重组人生长激素无菌粉末及其制备方法
IL272145A (en) *	2020-01-20	2021-07-29	Stem Cell Medicine Ltd	Cosmetic preparations with protein concentrate from a conditioned growth medium of stem cells from adipose tissue

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
IL86799A (en) *	1987-07-02	1993-03-15	Kabi Pharmacia Ab	Method and device for injection
US5096885A (en) *	1988-04-15	1992-03-17	Genentech, Inc.	Human growth hormone formulation
JP3108077B2 (ja) *	1989-06-08	2000-11-13	住友製薬株式会社	製剤投与器
US5126324A (en) *	1990-06-07	1992-06-30	Genentech, Inc.	Method of enhancing growth in patients using combination therapy
US5158546A (en) *	1991-08-07	1992-10-27	Habley Medical Technology Corp.	Controlled action self-mixing vial
US5281198A (en) *	1992-05-04	1994-01-25	Habley Medical Technology Corporation	Pharmaceutical component-mixing delivery assembly
SE9202108D0 (sv) *	1992-07-07	1992-07-07	Kabi Pharmacia Ab	Dual-chamber injection cartridge
CA2337745C (en) *	1992-07-31	2005-04-12	Genentech, Inc.	Human growth hormone aqueous formulation
US5334162A (en) *	1993-03-15	1994-08-02	Eli Lilly And Company	Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same
FR2752733B1 (fr) *	1996-09-05	1998-11-06	Inst Nat Sante Rech Med	Dispositif permeable a base d'hydrogel contenant des cellules vivantes, et ses applications

1997
- 1997-11-28 SE SE9704405A patent/SE9704405D0/xx unknown
1998
- 1998-11-19 CZ CZ20001948A patent/CZ300255B6/cs not_active IP Right Cessation
- 1998-11-19 AT AT98957272T patent/ATE354390T1/de not_active IP Right Cessation
- 1998-11-19 NZ NZ505150A patent/NZ505150A/xx unknown
- 1998-11-19 ES ES98957272T patent/ES2281142T3/es not_active Expired - Lifetime
- 1998-11-19 KR KR1020007005756A patent/KR100567358B1/ko not_active IP Right Cessation
- 1998-11-19 WO PCT/SE1998/002096 patent/WO1999027983A1/en active IP Right Grant
- 1998-11-19 HU HU0004410A patent/HUP0004410A3/hu unknown
- 1998-11-19 EP EP98957272A patent/EP1034007B1/en not_active Expired - Lifetime
- 1998-11-19 PL PL340731A patent/PL193243B1/pl not_active IP Right Cessation
- 1998-11-19 DK DK98957272T patent/DK1034007T3/da active
- 1998-11-19 RU RU2000116647/14A patent/RU2214285C2/ru not_active IP Right Cessation
- 1998-11-19 SK SK720-2000A patent/SK285668B6/sk not_active IP Right Cessation
- 1998-11-19 CA CA002311754A patent/CA2311754C/en not_active Expired - Lifetime
- 1998-11-19 CN CNB988115921A patent/CN1156315C/zh not_active Expired - Fee Related
- 1998-11-19 PT PT98957272T patent/PT1034007E/pt unknown
- 1998-11-19 AU AU13566/99A patent/AU742494B2/en not_active Ceased
- 1998-11-19 DE DE69837159T patent/DE69837159T2/de not_active Expired - Lifetime
- 1998-11-19 JP JP2000522963A patent/JP4564652B2/ja not_active Expired - Lifetime
- 1998-11-19 MX MXPA00005214A patent/MXPA00005214A/es not_active IP Right Cessation
- 1998-11-20 US US09/196,514 patent/US6152897A/en not_active Expired - Lifetime
2000
- 2000-05-29 NO NO20002754A patent/NO324692B1/no not_active IP Right Cessation
2001
- 2001-05-23 HK HK01103571A patent/HK1032920A1/xx not_active IP Right Cessation
2007
- 2007-03-20 CY CY20071100395T patent/CY1106403T1/el unknown

Also Published As

Publication number	Publication date
CA2311754A1 (en)	1999-06-10
DE69837159D1 (de)	2007-04-05
WO1999027983A1 (en)	1999-06-10
NZ505150A (en)	2002-08-28
KR20010032514A (ko)	2001-04-25
CY1106403T1 (el)	2011-10-12
NO324692B1 (no)	2007-12-03
HK1032920A1 (en)	2001-08-10
CA2311754C (en)	2007-12-18
EP1034007A1 (en)	2000-09-13
SE9704405D0 (sv)	1997-11-28
NO20002754D0 (no)	2000-05-29
JP2001524360A (ja)	2001-12-04
AU1356699A (en)	1999-06-16
EP1034007B1 (en)	2007-02-21
HUP0004410A3 (en)	2003-05-28
RU2214285C2 (ru)	2003-10-20
ATE354390T1 (de)	2007-03-15
CN1156315C (zh)	2004-07-07
AU742494B2 (en)	2002-01-03
PT1034007E (pt)	2007-04-30
KR100567358B1 (ko)	2006-04-04
CZ300255B6 (cs)	2009-04-01
DE69837159T2 (de)	2007-11-22
HUP0004410A2 (hu)	2001-04-28
PL193243B1 (pl)	2007-01-31
US6152897A (en)	2000-11-28
PL340731A1 (en)	2001-02-26
DK1034007T3 (da)	2007-05-21
SK7202000A3 (en)	2001-05-10
JP4564652B2 (ja)	2010-10-20
CN1280511A (zh)	2001-01-17
NO20002754L (no)	2000-05-29
CZ20001948A3 (cs)	2001-04-11
MXPA00005214A (es)	2002-04-24
ES2281142T3 (es)	2007-09-16

Legal Events

Date	Code	Title	Description
2010-08-09	MM4A	Patent lapsed due to non-payment of maintenance fees	Effective date: 20091119

Publication	Publication Date	Title
CA2102693C (en)	2008-06-17	Protein formulation comprising growth hormone
CA2252535C (en)	2009-06-23	A pharmaceutical formulation containing growth hormone, an amino acid and a non-ionic detergent
US20110054410A1 (en)	2011-03-03	Liquid formulation of fsh
SK285668B6 (sk)	2007-06-07	Spôsob výroby jednodávkovej striekačky obsahujúcej lyofilizovaný proteín na podávanie objemu menšieho ako 0,5 ml
JP2007532515A (ja)	2007-11-15	成長ホルモン液剤
KR101105486B1 (ko)	2012-01-13	Ｆｓｈ 및 ｌｈ과 비이온성 계면활성제의 액상 약제학적 제제
JPH10507181A (ja)	1998-07-14	成長ホルモンおよびバリンを含んでなる医薬製剤
EP0785797B1 (en)	2002-03-06	A pharmaceutical formulation comprising a growth hormone and leucine
US20030162711A1 (en)	2003-08-28	Pharmaceutical formulation
WO1995034318A1 (en)	1995-12-21	Solution comprising igf-i or any functional analogue thereof and method for its preparation