JP2010525033A5 - - Google Patents
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- Publication number
- JP2010525033A5 JP2010525033A5 JP2010504743A JP2010504743A JP2010525033A5 JP 2010525033 A5 JP2010525033 A5 JP 2010525033A5 JP 2010504743 A JP2010504743 A JP 2010504743A JP 2010504743 A JP2010504743 A JP 2010504743A JP 2010525033 A5 JP2010525033 A5 JP 2010525033A5
- Authority
- JP
- Japan
- Prior art keywords
- insulin
- aqueous solution
- less
- hexamer
- zinc ions
- Prior art date
- Legal status (The legal status 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 status listed.)
- Withdrawn
Links
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 238000002360 preparation method Methods 0.000 claims description 3
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims 56
- 102000004877 Insulin Human genes 0.000 claims 28
- 108090001061 Insulin Proteins 0.000 claims 28
- 229940125396 insulin Drugs 0.000 claims 28
- 239000007864 aqueous solution Substances 0.000 claims 12
- PTFCDOFLOPIGGS-UHFFFAOYSA-N Zinc dication Chemical compound [Zn+2] PTFCDOFLOPIGGS-UHFFFAOYSA-N 0.000 claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 5
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 4
- -1 histidine compound Chemical class 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N phenol group Chemical group C1(=CC=CC=C1)O ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 4
- 239000000243 solution Substances 0.000 claims 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims 3
- 239000013078 crystal Substances 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 238000004108 freeze drying Methods 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 238000001694 spray drying Methods 0.000 claims 2
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 claims 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 1
- 239000011701 zinc Substances 0.000 claims 1
- 229910052725 zinc Inorganic materials 0.000 claims 1
- 108010073961 Insulin Aspart Proteins 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 229960004717 insulin aspart Drugs 0.000 description 3
- VOMXSOIBEJBQNF-UTTRGDHVSA-N novorapid Chemical compound C([C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CS)NC(=O)[C@H]([C@@H](C)CC)NC(=O)[C@H](CO)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CS)NC(=O)[C@H](CS)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(O)=O)C1=CC=C(O)C=C1.C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CS)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(C)C)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CS)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 VOMXSOIBEJBQNF-UTTRGDHVSA-N 0.000 description 3
- 239000012153 distilled water Substances 0.000 description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 101000976075 Homo sapiens Insulin Proteins 0.000 description 1
- 241000700159 Rattus Species 0.000 description 1
- 108700043492 SprD Proteins 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000001198 duodenum Anatomy 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- PBGKTOXHQIOBKM-FHFVDXKLSA-N insulin (human) Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H]1CSSC[C@H]2C(=O)N[C@H](C(=O)N[C@@H](CO)C(=O)N[C@H](C(=O)N[C@H](C(N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3C=CC(O)=CC=3)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3NC=NC=3)NC(=O)[C@H](CO)NC(=O)CNC1=O)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(=O)N[C@@H](CC(N)=O)C(O)=O)=O)CSSC[C@@H](C(N2)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)[C@@H](C)CC)[C@@H](C)O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 PBGKTOXHQIOBKM-FHFVDXKLSA-N 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP07107221 | 2007-04-30 | ||
| EP07109906 | 2007-06-08 | ||
| EP07117798 | 2007-10-03 | ||
| PCT/EP2008/055341 WO2008132229A2 (en) | 2007-04-30 | 2008-04-30 | Highly concentrated insulin solutions and compositions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2010525033A JP2010525033A (ja) | 2010-07-22 |
| JP2010525033A5 true JP2010525033A5 (cg-RX-API-DMAC7.html) | 2014-09-18 |
Family
ID=39495516
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2010504743A Withdrawn JP2010525033A (ja) | 2007-04-30 | 2008-04-30 | 高濃縮のインスリン溶液及び組成物 |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US20100120660A1 (cg-RX-API-DMAC7.html) |
| EP (2) | EP2514412A1 (cg-RX-API-DMAC7.html) |
| JP (1) | JP2010525033A (cg-RX-API-DMAC7.html) |
| WO (1) | WO2008132229A2 (cg-RX-API-DMAC7.html) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101729986B1 (ko) | 2006-09-22 | 2017-04-25 | 노보 노르디스크 에이/에스 | 프로테아제 내성 인슐린 유사체 |
| WO2008132224A2 (en) | 2007-04-30 | 2008-11-06 | Novo Nordisk A/S | Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein |
| WO2009112583A2 (en) * | 2008-03-14 | 2009-09-17 | Novo Nordisk A/S | Protease-stabilized insulin analogues |
| DK2910570T3 (en) | 2008-03-18 | 2017-01-30 | Novo Nordisk As | Protease-stabilized acylated insulin analogues. |
| NZ597964A (en) * | 2009-07-31 | 2014-04-30 | Sanofi Aventis Deutschland | Long acting insulin composition |
| US10842951B2 (en) | 2010-01-12 | 2020-11-24 | Aerami Therapeutics, Inc. | Liquid insulin formulations and methods relating thereto |
| US9180261B2 (en) | 2010-01-12 | 2015-11-10 | Dance Biopharm Inc. | Preservative free insulin formulations and systems and methods for aerosolizing |
| CN103068400A (zh) * | 2010-06-25 | 2013-04-24 | 阿斯顿大学 | 具有脂类动员性质的糖蛋白及其治疗用途 |
| WO2012074989A2 (en) * | 2010-11-30 | 2012-06-07 | Joslin Diabetes Center, Inc. | Compositions and methods for the treatment of nervous disorders associated with diabetes |
| KR101978527B1 (ko) | 2011-03-10 | 2019-09-03 | 엑스에리스 파머수티클스, 인크. | 펩티드 약물의 비경구 주입을 위한 안정한 제형 |
| US9138479B2 (en) * | 2011-10-31 | 2015-09-22 | Xeris Pharmaceuticals, Inc. | Formulations for the treatment of diabetes |
| US9481721B2 (en) | 2012-04-11 | 2016-11-01 | Novo Nordisk A/S | Insulin formulations |
| US9125805B2 (en) | 2012-06-27 | 2015-09-08 | Xeris Pharmaceuticals, Inc. | Stable formulations for parenteral injection of small molecule drugs |
| US20140179597A1 (en) * | 2012-11-16 | 2014-06-26 | Steven Lehrer | Method for the treatment and prevention of Alzheimer's disease and central nervous system dysfunction |
| US9018162B2 (en) | 2013-02-06 | 2015-04-28 | Xeris Pharmaceuticals, Inc. | Methods for rapidly treating severe hypoglycemia |
| MX366636B (es) | 2013-10-07 | 2019-07-17 | Novo Nordisk As | Nuevo derivado de un análogo de insulina. |
| CN106573106B (zh) | 2014-08-06 | 2021-06-22 | Xeris药物公司 | 用于皮内和/或皮下注射糊剂的注射器、试剂盒和方法 |
| EP3261648B1 (en) * | 2015-02-25 | 2023-12-06 | Aerami Therapeutics, Inc. | Liquid insulin formulations and methods relating thereto |
| US9649364B2 (en) | 2015-09-25 | 2017-05-16 | Xeris Pharmaceuticals, Inc. | Methods for producing stable therapeutic formulations in aprotic polar solvents |
| US11590205B2 (en) | 2015-09-25 | 2023-02-28 | Xeris Pharmaceuticals, Inc. | Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents |
| US10821156B2 (en) * | 2016-04-12 | 2020-11-03 | Cell and Molecular Tissue Engineering, LLC | Systems, methods and products for minimizing tissue reactions and tissue injury at an infusion site |
| GB201607918D0 (en) | 2016-05-06 | 2016-06-22 | Arecor Ltd | Novel formulations |
| TWI700091B (zh) | 2016-12-16 | 2020-08-01 | 丹麥商諾佛 儂迪克股份有限公司 | 含胰島素醫藥組成物 |
| BR112019024987A2 (pt) | 2017-06-02 | 2020-06-16 | Xeris Pharmaceuticals, Inc. | Formulações de fármaco de molécula pequena resistente à precipitação |
| US20230025595A1 (en) * | 2021-07-13 | 2023-01-26 | America Great Health, a California Corporation | Formulation and Method of Preparing Divalent Cation Charged Insulin for Oral Administration |
| US11478534B1 (en) * | 2021-07-13 | 2022-10-25 | America Great Health | Formulation and method of preparing zinc-charged insulin for oral administration |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PH23446A (en) * | 1986-10-20 | 1989-08-07 | Novo Industri As | Peptide preparations |
| WO1988006599A1 (en) * | 1987-02-25 | 1988-09-07 | Novo Industri A/S | Novel insulin derivatives |
| US5506203C1 (en) * | 1993-06-24 | 2001-02-06 | Astra Ab | Systemic administration of a therapeutic preparation |
| US5474978A (en) * | 1994-06-16 | 1995-12-12 | Eli Lilly And Company | Insulin analog formulations |
| DE69826705T2 (de) * | 1997-11-12 | 2006-02-23 | Alza Corp., Palo Alto | Verfahren zur dermalen verabreichung von polypeptiden |
| PL197504B1 (pl) * | 1998-10-16 | 2008-04-30 | Novo Nordisk As | Trwałe stężone preparaty insulinowe do podawania do płuc |
| EP1131089B1 (en) * | 1998-11-18 | 2004-02-18 | Novo Nordisk A/S | Stable aqueous insulin preparations without phenol and cresol |
| US6489292B1 (en) * | 1998-11-18 | 2002-12-03 | Novo Nordisk A/S | Stable aqueous insulin preparations without phenol and cresol |
| JP3799924B2 (ja) | 2000-01-11 | 2006-07-19 | 株式会社日立製作所 | 電力用遮断器および発電所電気回路装置 |
| DE10114178A1 (de) * | 2001-03-23 | 2002-10-10 | Aventis Pharma Gmbh | Zinkfreie und zinkarme Insulinzubereitungen mit verbesserter Stabilität |
| DE10227232A1 (de) * | 2002-06-18 | 2004-01-15 | Aventis Pharma Deutschland Gmbh | Saure Insulinzubereitungen mit verbesserter Stabilität |
| US20100210506A1 (en) * | 2005-10-20 | 2010-08-19 | Mdrna, Inc. | Intranasal administration of rapid acting insulin |
| WO2008132224A2 (en) * | 2007-04-30 | 2008-11-06 | Novo Nordisk A/S | Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein |
-
2008
- 2008-04-30 US US12/598,147 patent/US20100120660A1/en not_active Abandoned
- 2008-04-30 EP EP12162963A patent/EP2514412A1/en not_active Withdrawn
- 2008-04-30 JP JP2010504743A patent/JP2010525033A/ja not_active Withdrawn
- 2008-04-30 WO PCT/EP2008/055341 patent/WO2008132229A2/en not_active Ceased
- 2008-04-30 EP EP08736644A patent/EP2152243A2/en not_active Withdrawn
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