NO311168B1 - Lyosf¶rer omfattende gonadotropin, fremgangsmåte ved fremstilling derav og farmasöytisk preparat omfattende sådanne - Google Patents

Lyosf¶rer omfattende gonadotropin, fremgangsmåte ved fremstilling derav og farmasöytisk preparat omfattende sådanne Download PDF

Info

Publication number: NO311168B1
Authority: NO; Norway
Prior art keywords: gonadotropin; lyospheres; lyosphere; freeze; fsh
Prior art date: 1993-04-28

Application number

NO19954320A

Other languages

English (en)

Norwegian (no)

Other versions

NO954320D0 (no

NO954320L (no

Inventor

Arnold Titus Philip Skrabanja

Herman Vromans

Original Assignee

Akzo Nobel Nv

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.)

1993-04-28

Filing date

1995-10-27

Publication date

2001-10-22

1995-10-27 Application filed by Akzo Nobel Nv filed Critical Akzo Nobel Nv

1995-10-27 Publication of NO954320D0 publication Critical patent/NO954320D0/no

1995-10-27 Publication of NO954320L publication Critical patent/NO954320L/no

2001-10-22 Publication of NO311168B1 publication Critical patent/NO311168B1/no

Links

102000006771 Gonadotropins Human genes 0.000 title claims description 20
108010086677 Gonadotropins Proteins 0.000 title claims description 20
239000002622 gonadotropin Substances 0.000 title claims description 20
238000000034 method Methods 0.000 title description 5
239000008194 pharmaceutical composition Substances 0.000 title 1
239000000825 pharmaceutical preparation Substances 0.000 claims description 8
239000000546 pharmaceutical excipient Substances 0.000 claims description 4
238000004519 manufacturing process Methods 0.000 claims description 2
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 description 10
229930006000 Sucrose Natural products 0.000 description 10
239000001509 sodium citrate Substances 0.000 description 10
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 10
239000005720 sucrose Substances 0.000 description 10
229920001213 Polysorbate 20 Polymers 0.000 description 9
239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 9
235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 9
238000004108 freeze drying Methods 0.000 description 8
239000000243 solution Substances 0.000 description 8
229940068977 polysorbate 20 Drugs 0.000 description 7
230000000694 effects Effects 0.000 description 6
102000011022 Chorionic Gonadotropin Human genes 0.000 description 5
108010062540 Chorionic Gonadotropin Proteins 0.000 description 5
102000012673 Follicle Stimulating Hormone Human genes 0.000 description 5
108010079345 Follicle Stimulating Hormone Proteins 0.000 description 5
IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 4
229940028334 follicle stimulating hormone Drugs 0.000 description 4
229940084986 human chorionic gonadotropin Drugs 0.000 description 4
HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
229940094892 gonadotropins Drugs 0.000 description 3
238000011084 recovery Methods 0.000 description 3
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 2
VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
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 2
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 2
239000003708 ampul Substances 0.000 description 2
238000009472 formulation Methods 0.000 description 2
238000000338 in vitro Methods 0.000 description 2
239000007788 liquid Substances 0.000 description 2
239000000203 mixture Substances 0.000 description 2
229910052757 nitrogen Inorganic materials 0.000 description 2
239000002245 particle Substances 0.000 description 2
230000002485 urinary effect Effects 0.000 description 2
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 description 1
229920002307 Dextran Polymers 0.000 description 1
102000004190 Enzymes Human genes 0.000 description 1
108090000790 Enzymes Proteins 0.000 description 1
102000009151 Luteinizing Hormone Human genes 0.000 description 1
108010073521 Luteinizing Hormone Proteins 0.000 description 1
239000011149 active material Substances 0.000 description 1
239000013011 aqueous formulation Substances 0.000 description 1
239000011324 bead Substances 0.000 description 1
230000015556 catabolic process Effects 0.000 description 1
238000006731 degradation reaction Methods 0.000 description 1
238000004090 dissolution Methods 0.000 description 1
239000003814 drug Substances 0.000 description 1
230000004720 fertilization Effects 0.000 description 1
239000000945 filler Substances 0.000 description 1
238000001914 filtration Methods 0.000 description 1
230000008105 immune reaction Effects 0.000 description 1
238000003018 immunoassay Methods 0.000 description 1
239000004615 ingredient Substances 0.000 description 1
238000002955 isolation Methods 0.000 description 1
FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 description 1
239000000463 material Substances 0.000 description 1
239000012528 membrane Substances 0.000 description 1
229920000136 polysorbate Polymers 0.000 description 1
229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
239000001267 polyvinylpyrrolidone Substances 0.000 description 1
235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
238000010188 recombinant method Methods 0.000 description 1
239000003381 stabilizer Substances 0.000 description 1
239000004094 surface-active agent Substances 0.000 description 1
-1 their production Substances 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
- 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
- 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
- A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Bioinformatics & Cheminformatics (AREA)
Engineering & Computer Science (AREA)
Public Health (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Medicinal Chemistry (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Veterinary Medicine (AREA)
Endocrinology (AREA)
Reproductive Health (AREA)
Zoology (AREA)
Gastroenterology & Hepatology (AREA)
Immunology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
Nitrogen Condensed Heterocyclic Rings (AREA)

NO19954320A 1993-04-28 1995-10-27 Lyosf¶rer omfattende gonadotropin, fremgangsmåte ved fremstilling derav og farmasöytisk preparat omfattende sådanne NO311168B1 (no)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
EP93201215		1993-04-28
PCT/EP1994/001303 WO1994025005A1 (en)	1993-04-28	1994-04-25	Lyospheres comprising gonadotropin

Publications (3)

Publication Number	Publication Date
NO954320D0 NO954320D0 (no)	1995-10-27
NO954320L NO954320L (no)	1995-10-27
NO311168B1 true NO311168B1 (no)	2001-10-22

Family

ID=8213798

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
NO19954320A NO311168B1 (no)	1993-04-28	1995-10-27	Lyosf¶rer omfattende gonadotropin, fremgangsmåte ved fremstilling derav og farmasöytisk preparat omfattende sådanne

Country Status (16)

Country	Link
US (1)	US5656597A (ja)
EP (1)	EP0695171B1 (ja)
JP (1)	JPH08509483A (ja)
KR (1)	KR100334856B1 (ja)
AT (1)	ATE146360T1 (ja)
AU (1)	AU679986B2 (ja)
CA (1)	CA2150251C (ja)
DE (1)	DE69401204T2 (ja)
DK (1)	DK0695171T3 (ja)
ES (1)	ES2098140T3 (ja)
FI (1)	FI112324B (ja)
GR (1)	GR3022510T3 (ja)
HK (1)	HK1002017A1 (ja)
NO (1)	NO311168B1 (ja)
NZ (1)	NZ265956A (ja)
WO (1)	WO1994025005A1 (ja)

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IL120202A (en)	1996-03-07	2001-03-19	Akzo Nobel Nv	Container with freeze-dried vaccine components
GB2329124B (en) *	1997-09-12	2002-05-08	Hiran Asoka Malinga Ratwatte	Method of forming dose units of active agents
AU773556B2 (en) *	1999-04-05	2004-05-27	Mannkind Corporation	Methods for fine powder formation
EP1658840A1 (en) *	1999-04-05	2006-05-24	Mannkind Corporation	Methods for fine powder formation
US9006175B2 (en)	1999-06-29	2015-04-14	Mannkind Corporation	Potentiation of glucose elimination
EP1494732B1 (en)	2002-03-20	2008-01-30	MannKind Corporation	Inhalation apparatus
US20040248784A1 (en) *	2003-06-03	2004-12-09	Marco Filicori	Unitary combinations of FSH and hCG
US20060222694A1 (en) *	2003-06-27	2006-10-05	Oh Choon K	Stabilized topotecan liposomal composition and methods
KR101273120B1 (ko)	2004-08-20	2013-06-13	맨카인드 코포레이션	다이케토피페라진 합성의 촉매 작용
KR20130066695A (ko)	2004-08-23	2013-06-20	맨카인드 코포레이션	약물 전달용 디케토피페라진염, 디케토모르포린염 또는 디케토디옥산염
IN2014DN09128A (ja)	2005-09-14	2015-07-10	Mannkind Corp
BRPI0707991B8 (pt)	2006-02-22	2021-05-25	Mannkind Corp	métodos de preparação de um medicamento em pó seco com uma propriedade farmacêutica melhorada, dito pó seco e uso de uma quantidade efetiva do pó seco
TWI436789B (zh)	2008-01-21	2014-05-11	Intervet Int Bv	含有藥學化合物的顆粒之冷凍乾燥方法及含有此顆粒的藥學包
CA2716399C (en)	2008-03-05	2020-07-21	Pierre Chouvenc	Process for stabilizing an adjuvant containing vaccine composition
CN101269215B (zh) *	2008-05-15	2011-03-23	上海天伟生物制药有限公司	一种糖蛋白激素组合物
CN109568740B (zh)	2008-06-13	2022-05-27	曼金德公司	干粉吸入器和用于药物输送的***
US8485180B2 (en)	2008-06-13	2013-07-16	Mannkind Corporation	Dry powder drug delivery system
ES2904623T3 (es)	2008-06-20	2022-04-05	Mannkind Corp	Aparato interactivo para establecer un perfil en tiempo real de esfuerzos de inhalación
TWI494123B (zh)	2008-08-11	2015-08-01	Mannkind Corp	超快起作用胰島素之用途
US8314106B2 (en)	2008-12-29	2012-11-20	Mannkind Corporation	Substituted diketopiperazine analogs for use as drug delivery agents
PL2405963T3 (pl)	2009-03-11	2014-04-30	Mannkind Corp	Urządzenie, układ i sposób pomiaru oporu inhalatora
KR101875969B1 (ko)	2009-06-12	2018-07-06	맨카인드 코포레이션	한정된 비표면적을 갖는 디케토피페라진 마이크로입자
EP2496295A1 (en)	2009-11-03	2012-09-12	MannKind Corporation	An apparatus and method for simulating inhalation efforts
KR20130117755A (ko)	2010-06-21	2013-10-28	맨카인드 코포레이션	건조 분말 약물 운반 시스템 및 방법
JP6133270B2 (ja)	2011-04-01	2017-05-24	マンカインドコーポレイション	薬剤カートリッジのためのブリスター包装
WO2012174472A1 (en)	2011-06-17	2012-12-20	Mannkind Corporation	High capacity diketopiperazine microparticles
BR112014009686A2 (pt)	2011-10-24	2018-08-07	Mannkind Corp	composição analgésica inalável, pó seco e método para tratar dor
AU2013289957B2 (en)	2012-07-12	2017-02-23	Mannkind Corporation	Dry powder drug delivery systems and methods
EP2911690A1 (en)	2012-10-26	2015-09-02	MannKind Corporation	Inhalable influenza vaccine compositions and methods
ES2754388T3 (es)	2013-03-15	2020-04-17	Mannkind Corp	Composiciones y métodos de dicetopiperazina microcristalina
WO2015021064A1 (en)	2013-08-05	2015-02-12	Mannkind Corporation	Insufflation apparatus and methods
US10307464B2 (en)	2014-03-28	2019-06-04	Mannkind Corporation	Use of ultrarapid acting insulin
US10561806B2 (en)	2014-10-02	2020-02-18	Mannkind Corporation	Mouthpiece cover for an inhaler
US10617650B2 (en) *	2015-10-16	2020-04-14	Merck Sharp & Dohme Corp.	Process for preparing formulations for gastrointestinal-targeted therapies

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US3932943A (en) *	1970-08-14	1976-01-20	E. I. Du Pont De Nemours And Company	Method of preparation of lyophilized biological products
ATE14047T1 (de) *	1981-12-11	1985-07-15	Wyeth John & Brother Ltd	Verfahren und vorrichtung zum gefrieren einer fluessigkeit.
JPS60258125A (ja) *	1984-06-06	1985-12-20	Hayashibara Biochem Lab Inc	蛋白性生理活性物質を含有する水溶性乾燥物
CA2030551C (en) *	1989-05-01	1998-08-25	Wayne Gombotz	Process for producing small particles of biologically active molecules
IE64738B1 (en) *	1990-03-20	1995-09-06	Akzo Nv	Stabilized gonadotropin containing preparations

1994
- 1994-04-25 JP JP6523868A patent/JPH08509483A/ja active Pending
- 1994-04-25 ES ES94915121T patent/ES2098140T3/es not_active Expired - Lifetime
- 1994-04-25 NZ NZ265956A patent/NZ265956A/en not_active IP Right Cessation
- 1994-04-25 EP EP94915121A patent/EP0695171B1/en not_active Expired - Lifetime
- 1994-04-25 AT AT94915121T patent/ATE146360T1/de active
- 1994-04-25 AU AU66488/94A patent/AU679986B2/en not_active Ceased
- 1994-04-25 WO PCT/EP1994/001303 patent/WO1994025005A1/en active IP Right Grant
- 1994-04-25 KR KR1019950702180A patent/KR100334856B1/ko not_active IP Right Cessation
- 1994-04-25 CA CA002150251A patent/CA2150251C/en not_active Expired - Fee Related
- 1994-04-25 DE DE69401204T patent/DE69401204T2/de not_active Expired - Lifetime
- 1994-04-25 DK DK94915121.1T patent/DK0695171T3/da active
- 1994-04-25 US US08/454,333 patent/US5656597A/en not_active Expired - Lifetime
1995
- 1995-07-14 FI FI953442A patent/FI112324B/fi not_active IP Right Cessation
- 1995-10-27 NO NO19954320A patent/NO311168B1/no not_active IP Right Cessation
1997
- 1997-02-11 GR GR970400207T patent/GR3022510T3/el unknown
1998
- 1998-02-11 HK HK98101026A patent/HK1002017A1/xx not_active IP Right Cessation

Also Published As

Publication number	Publication date
NZ265956A (en)	1996-09-25
US5656597A (en)	1997-08-12
NO954320D0 (no)	1995-10-27
FI953442A0 (fi)	1995-07-14
GR3022510T3 (en)	1997-05-31
DK0695171T3 (da)	1997-06-02
DE69401204D1 (de)	1997-01-30
ES2098140T3 (es)	1997-04-16
FI112324B (fi)	2003-11-28
EP0695171A1 (en)	1996-02-07
EP0695171B1 (en)	1996-12-18
AU679986B2 (en)	1997-07-17
AU6648894A (en)	1994-11-21
CA2150251A1 (en)	1994-11-10
NO954320L (no)	1995-10-27
HK1002017A1 (en)	1998-07-24
KR950703934A (ko)	1995-11-17
DE69401204T2 (de)	1997-06-05
KR100334856B1 (ko)	2002-11-07
WO1994025005A1 (en)	1994-11-10
FI953442A (fi)	1995-07-14
CA2150251C (en)	2005-02-22
ATE146360T1 (de)	1997-01-15
JPH08509483A (ja)	1996-10-08

Legal Events

Date	Code	Title	Description
2012-11-26	MM1K	Lapsed by not paying the annual fees

Publication	Publication Date	Title
NO311168B1 (no)	2001-10-22	Lyosf¶rer omfattende gonadotropin, fremgangsmåte ved fremstilling derav og farmasöytisk preparat omfattende sådanne
DE69813322T2 (de)	2004-02-19	Flüssige gonadotropinhaltige Arzneimittel
US20210244669A1 (en)	2021-08-12	Formulations and methods for lyophilization and lyophilates provided thereby
DE69102465T2 (de)	1995-03-02	Stabilisierte Gonadotropin enthaltende Zubereitungen.
EP2598160B1 (en)	2017-02-22	Stabilization of fsh
DE202009009905U1 (de)	2009-10-29	Flüssig-Formulierung von FSH
JPH08507064A (ja)	1996-07-30	有機溶媒を用いて処理したポリペプチドの賦形剤安定化
JP3702313B2 (ja)	2005-10-05	ゴナドトロピン含有薬剤組成物
Deguettes et al.	2020	Controlled delivery of follicle-stimulating hormone in cattle
US5384132A (en)	1995-01-24	Stabilized gonadotropin containing preparations
Yang et al.	1995	Effects of a gonadotropin releasing hormone agonist on oocyte maturation, fertilization, and embryonal development in mice
DE69105114T2 (de)	1995-05-04	Methode zur erhöhung der fruchtbarkeit weiblicher säuger.
Wagner et al.	1973	Failure of USP tablet disintegration test to predict performance in man
Xiao et al.	1998	Human placenta and fetal membranes contain peptide YY1-36 and peptide YY3-36
Moes et al.	1993	Arginine stimulated glucagon and insulin secretion by islets of Langerhans of pregnant and lactating rats
WO1995022342A1 (en)	1995-08-24	Pharmaceutical formulations of ciliary neurotrophic factor
Howles	2019	The r-hFSH Doses: Gonadotropins Which or u-hFSH, Protocol Biosimilars, in IVF Regimens
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