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 PDFInfo
- Publication number
- NO311168B1 NO311168B1 NO19954320A NO954320A NO311168B1 NO 311168 B1 NO311168 B1 NO 311168B1 NO 19954320 A NO19954320 A NO 19954320A NO 954320 A NO954320 A NO 954320A NO 311168 B1 NO311168 B1 NO 311168B1
- Authority
- NO
- Norway
- Prior art keywords
- gonadotropin
- lyospheres
- lyosphere
- freeze
- fsh
- Prior art date
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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Endocrinology (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Reproductive Health (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
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 |
|---|---|
| NO954320L NO954320L (no) | 1995-10-27 |
| NO954320D0 NO954320D0 (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 (fi) |
| EP (1) | EP0695171B1 (fi) |
| JP (1) | JPH08509483A (fi) |
| KR (1) | KR100334856B1 (fi) |
| AT (1) | ATE146360T1 (fi) |
| AU (1) | AU679986B2 (fi) |
| CA (1) | CA2150251C (fi) |
| DE (1) | DE69401204T2 (fi) |
| DK (1) | DK0695171T3 (fi) |
| ES (1) | ES2098140T3 (fi) |
| FI (1) | FI112324B (fi) |
| GR (1) | GR3022510T3 (fi) |
| HK (1) | HK1002017A1 (fi) |
| NO (1) | NO311168B1 (fi) |
| NZ (1) | NZ265956A (fi) |
| WO (1) | WO1994025005A1 (fi) |
Families Citing this family (34)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| EP1658840A1 (en) * | 1999-04-05 | 2006-05-24 | Mannkind Corporation | Methods for fine powder formation |
| WO2000059476A1 (en) * | 1999-04-05 | 2000-10-12 | Pharmaceutical Discovery Corporation | Methods for fine powder formation |
| US9006175B2 (en) | 1999-06-29 | 2015-04-14 | Mannkind Corporation | Potentiation of glucose elimination |
| DE60318938T2 (de) | 2002-03-20 | 2009-01-22 | Mannkind Corp., Valencia | Inhalationsgerät |
| 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 |
| WO2006023849A2 (en) | 2004-08-20 | 2006-03-02 | Mannkind Corporation | Catalysis of diketopiperazine synthesis |
| JP4990142B2 (ja) | 2004-08-23 | 2012-08-01 | マンカインド コーポレイション | 薬物送達のためのジケトピペラジン塩、ジケトモルホリン塩、又はジケトジオキサン塩 |
| IN2014DN09128A (fi) | 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 |
| CN105944095B (zh) | 2008-03-05 | 2021-04-02 | 赛诺菲巴斯德有限公司 | 一种使含佐剂的疫苗组合物稳定的方法 |
| 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 |
| US8485180B2 (en) | 2008-06-13 | 2013-07-16 | Mannkind Corporation | Dry powder drug delivery system |
| EP3281663B8 (en) | 2008-06-13 | 2022-09-21 | MannKind Corporation | Breath powered dry powder inhaler for drug delivery |
| BRPI0914308B8 (pt) | 2008-06-20 | 2021-06-22 | Mannkind Corp | sistema de inalação |
| TWI614024B (zh) | 2008-08-11 | 2018-02-11 | 曼凱公司 | 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 |
| WO2010105094A1 (en) | 2009-03-11 | 2010-09-16 | Mannkind Corporation | Apparatus, system and method for measuring resistance of an inhaler |
| WO2010144789A2 (en) | 2009-06-12 | 2010-12-16 | Mannkind Corporation | Diketopiperazine microparticles with defined specific surface areas |
| WO2011056889A1 (en) | 2009-11-03 | 2011-05-12 | Mannkind Corporation | An apparatus and method for simulating inhalation efforts |
| AU2011271097B2 (en) | 2010-06-21 | 2014-11-27 | Mannkind Corporation | Dry powder drug delivery system and methods |
| EP2694402B1 (en) | 2011-04-01 | 2017-03-22 | MannKind Corporation | Blister package for pharmaceutical cartridges |
| WO2012174472A1 (en) | 2011-06-17 | 2012-12-20 | Mannkind Corporation | High capacity diketopiperazine microparticles |
| CA2852536A1 (en) | 2011-10-24 | 2013-05-02 | Mannkind Corporation | Methods and compositions for treating pain |
| WO2014012069A2 (en) | 2012-07-12 | 2014-01-16 | 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 |
| KR102499439B1 (ko) | 2013-03-15 | 2023-02-13 | 맨카인드 코포레이션 | 미세결정성 디케토피페라진 조성물 및 방법 |
| CA2920488C (en) | 2013-08-05 | 2022-04-26 | 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 |
| JP6855469B2 (ja) * | 2015-10-16 | 2021-04-07 | メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． | 消化器標的療法のための処方物を調製するための工程 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3932943A (en) * | 1970-08-14 | 1976-01-20 | E. I. Du Pont De Nemours And Company | Method of preparation of lyophilized biological products |
| DE3264450D1 (en) * | 1981-12-11 | 1985-08-01 | Wyeth John & Brother Ltd | Process and apparatus for freezing a liquid medium |
| 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 |
| JPH0739339B2 (ja) * | 1989-05-01 | 1995-05-01 | アルカーメス コントロールド セラピューティクス，インコーポレイテッド | 生物活性を有する分子の小粒子の製造方法 |
| IE64738B1 (en) * | 1990-03-20 | 1995-09-06 | Akzo Nv | Stabilized gonadotropin containing preparations |
-
1994
- 1994-04-25 AT AT94915121T patent/ATE146360T1/de active
- 1994-04-25 DE DE69401204T patent/DE69401204T2/de not_active Expired - Lifetime
- 1994-04-25 CA CA002150251A patent/CA2150251C/en not_active Expired - Fee Related
- 1994-04-25 EP EP94915121A patent/EP0695171B1/en not_active Expired - Lifetime
- 1994-04-25 NZ NZ265956A patent/NZ265956A/en not_active IP Right Cessation
- 1994-04-25 US US08/454,333 patent/US5656597A/en not_active Expired - Lifetime
- 1994-04-25 AU AU66488/94A patent/AU679986B2/en not_active Ceased
- 1994-04-25 DK DK94915121.1T patent/DK0695171T3/da active
- 1994-04-25 WO PCT/EP1994/001303 patent/WO1994025005A1/en active IP Right Grant
- 1994-04-25 JP JP6523868A patent/JPH08509483A/ja active Pending
- 1994-04-25 KR KR1019950702180A patent/KR100334856B1/ko not_active IP Right Cessation
- 1994-04-25 ES ES94915121T patent/ES2098140T3/es 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 |
|---|---|
| GR3022510T3 (en) | 1997-05-31 |
| NO954320L (no) | 1995-10-27 |
| ATE146360T1 (de) | 1997-01-15 |
| AU6648894A (en) | 1994-11-21 |
| FI953442A (fi) | 1995-07-14 |
| ES2098140T3 (es) | 1997-04-16 |
| DE69401204D1 (de) | 1997-01-30 |
| NO954320D0 (no) | 1995-10-27 |
| HK1002017A1 (en) | 1998-07-24 |
| JPH08509483A (ja) | 1996-10-08 |
| AU679986B2 (en) | 1997-07-17 |
| DK0695171T3 (da) | 1997-06-02 |
| EP0695171A1 (en) | 1996-02-07 |
| CA2150251C (en) | 2005-02-22 |
| FI953442A0 (fi) | 1995-07-14 |
| NZ265956A (en) | 1996-09-25 |
| EP0695171B1 (en) | 1996-12-18 |
| CA2150251A1 (en) | 1994-11-10 |
| KR100334856B1 (ko) | 2002-11-07 |
| WO1994025005A1 (en) | 1994-11-10 |
| KR950703934A (ko) | 1995-11-17 |
| US5656597A (en) | 1997-08-12 |
| FI112324B (fi) | 2003-11-28 |
| DE69401204T2 (de) | 1997-06-05 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM1K | Lapsed by not paying the annual fees |