JP2016539921A5 - - Google Patents
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- Publication number
- JP2016539921A5 JP2016539921A5 JP2016524503A JP2016524503A JP2016539921A5 JP 2016539921 A5 JP2016539921 A5 JP 2016539921A5 JP 2016524503 A JP2016524503 A JP 2016524503A JP 2016524503 A JP2016524503 A JP 2016524503A JP 2016539921 A5 JP2016539921 A5 JP 2016539921A5
- Authority
- JP
- Japan
- Prior art keywords
- aqueous pharmaceutical
- pharmaceutical formulation
- formulation according
- diabetes mellitus
- type
- 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.)
- Granted
Links
- 239000008194 pharmaceutical composition Substances 0.000 claims 29
- 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 14
- 102000004877 Insulin Human genes 0.000 claims 7
- 108090001061 Insulin Proteins 0.000 claims 7
- 229940125396 insulin Drugs 0.000 claims 7
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 claims 4
- 238000009472 formulation Methods 0.000 claims 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerol group Chemical group OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 4
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims 4
- 239000000203 mixture Substances 0.000 claims 4
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 4
- 239000002736 nonionic surfactant Substances 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims 2
- 150000001413 amino acids Chemical class 0.000 claims 2
- 235000011187 glycerol Nutrition 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N phenol group Chemical group C1(=CC=CC=C1)O ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 2
- 239000003755 preservative agent Substances 0.000 claims 2
- 239000000126 substance Substances 0.000 claims 2
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical group OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 2
- 229960000281 trometamol Drugs 0.000 claims 2
- 239000011701 zinc Substances 0.000 claims 2
- 229910052725 zinc Inorganic materials 0.000 claims 2
- 239000004475 Arginine Substances 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 1
- 239000012928 buffer substance Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229930182817 methionine Natural products 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 229960000502 poloxamer Drugs 0.000 claims 1
- 229920001983 poloxamer Polymers 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 239000012929 tonicity agent Substances 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13306475.8 | 2013-10-25 | ||
| EP13306475 | 2013-10-25 | ||
| PCT/EP2014/072915 WO2015059302A1 (en) | 2013-10-25 | 2014-10-24 | Stable formulation of insulin glulisine |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016539921A JP2016539921A (ja) | 2016-12-22 |
| JP2016539921A5 true JP2016539921A5 (enExample) | 2017-11-30 |
| JP6525987B2 JP6525987B2 (ja) | 2019-06-05 |
Family
ID=49552301
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016524503A Expired - Fee Related JP6525987B2 (ja) | 2013-10-25 | 2014-10-24 | インスリングルリジンの安定製剤 |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US20150119323A1 (enExample) |
| EP (1) | EP3060240A1 (enExample) |
| JP (1) | JP6525987B2 (enExample) |
| KR (1) | KR20160074562A (enExample) |
| CN (1) | CN105705161A (enExample) |
| AR (1) | AR098168A1 (enExample) |
| AU (1) | AU2014338863A1 (enExample) |
| BR (1) | BR112016008736A2 (enExample) |
| CA (1) | CA2928320A1 (enExample) |
| CL (1) | CL2016000950A1 (enExample) |
| HK (1) | HK1225613A1 (enExample) |
| IL (1) | IL245109A0 (enExample) |
| MX (1) | MX2016005395A (enExample) |
| PH (1) | PH12016500720A1 (enExample) |
| RU (1) | RU2691059C2 (enExample) |
| SG (2) | SG11201602939QA (enExample) |
| TW (1) | TW201605489A (enExample) |
| WO (1) | WO2015059302A1 (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5694779B2 (ja) | 2008-01-09 | 2015-04-01 | サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | 極度に遅延した時間作用プロファイルを有する新規なインスリン誘導体 |
| LT3228320T (lt) | 2008-10-17 | 2020-03-10 | Sanofi-Aventis Deutschland Gmbh | Insulino ir glp-1 agonisto derinys |
| PL2498802T3 (pl) | 2009-11-13 | 2015-06-30 | Sanofi Aventis Deutschland | Kompozycja farmaceutyczna zawierająca agonistę GLP-1, insulinę i metioninę |
| EP2498801B1 (de) | 2009-11-13 | 2018-01-24 | Sanofi-Aventis Deutschland GmbH | HARMAZEUTISCHE ZUSAMMENSETZUNG UMFASSEND desPro36Exendin-4(1-39)-Lys6-NH2 UND METHIONIN |
| SI2611458T1 (sl) | 2010-08-30 | 2017-01-31 | Sanofi-Aventis Deutschland Gmbh | Uporaba AVE0010 za izdelavo zdravila za zdravljenje sladkorne bolezni tipa 2 |
| US9821032B2 (en) | 2011-05-13 | 2017-11-21 | Sanofi-Aventis Deutschland Gmbh | Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin |
| AR087744A1 (es) | 2011-09-01 | 2014-04-16 | Sanofi Aventis Deutschland | Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa |
| CA2970200A1 (en) | 2014-12-12 | 2016-06-16 | Sanofi-Aventis Deutschland Gmbh | Insulin glargine/lixisenatide fixed ratio formulation |
| TWI748945B (zh) | 2015-03-13 | 2021-12-11 | 德商賽諾菲阿凡提斯德意志有限公司 | 第２型糖尿病病患治療 |
| TW201705975A (zh) | 2015-03-18 | 2017-02-16 | 賽諾菲阿凡提斯德意志有限公司 | 第２型糖尿病病患之治療 |
| GB201607918D0 (en) * | 2016-05-06 | 2016-06-22 | Arecor Ltd | Novel formulations |
| IL277721B2 (en) | 2018-04-04 | 2024-03-01 | Arecor Ltd | Medical infusion pump system for the delivery of an insulin compound |
| FR3083700B1 (fr) * | 2018-07-13 | 2021-03-12 | Adocia | Formulation thermostable d'insuline humaine a21g |
| AR131148A1 (es) * | 2022-11-26 | 2025-02-19 | Obshchestvo S Ogranichennoy Otvetstvennostyu «Geropharm» | Composiciones de insulina de acción rápida (variantes de las mismas) |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5474978A (en) | 1994-06-16 | 1995-12-12 | Eli Lilly And Company | Insulin analog formulations |
| US5866538A (en) | 1996-06-20 | 1999-02-02 | Novo Nordisk A/S | Insulin preparations containing NaCl |
| US5948751A (en) | 1996-06-20 | 1999-09-07 | Novo Nordisk A/S | X14-mannitol |
| AR012894A1 (es) | 1997-06-13 | 2000-11-22 | Lilly Co Eli | Formulacion de insulina en solucion estable, su uso para preparar un medicamento y proceso para la preparacion de la misma. |
| DE10114178A1 (de) * | 2001-03-23 | 2002-10-10 | Aventis Pharma Gmbh | Zinkfreie und zinkarme Insulinzubereitungen mit verbesserter Stabilität |
| TWI394580B (zh) * | 2008-04-28 | 2013-05-01 | Halozyme Inc | 超快起作用胰島素組成物 |
| EP2308473A4 (en) * | 2008-07-01 | 2013-01-09 | Nitto Denko Corp | PHARMACEUTICAL COMPOSITION CONTAINING MICROPARTICLES WITH SURFACE COATING |
| EP3202394A1 (de) * | 2009-07-06 | 2017-08-09 | Sanofi-Aventis Deutschland GmbH | Wässrige insulinzubereitungen enthaltend methionin |
| MA33467B1 (fr) * | 2009-07-31 | 2012-07-03 | Sanofi Aventis Deutschland | Promédicaments comprenant un conjugué insuline-lieur |
| PL2498802T3 (pl) * | 2009-11-13 | 2015-06-30 | Sanofi Aventis Deutschland | Kompozycja farmaceutyczna zawierająca agonistę GLP-1, insulinę i metioninę |
| CN101912600B (zh) * | 2010-01-11 | 2014-01-29 | 杨国汉 | 改善胰岛素在溶液中稳定性的方法 |
| CA2839511C (en) * | 2011-06-17 | 2018-07-31 | Halozyme, Inc. | Stable formulations of a hyaluronan-degrading enzyme |
| US20130011378A1 (en) * | 2011-06-17 | 2013-01-10 | Tzung-Horng Yang | Stable formulations of a hyaluronan-degrading enzyme |
| CN104902922B (zh) * | 2012-11-13 | 2017-12-12 | 阿道恰公司 | 包含经取代阴离子化合物的速效胰岛素制剂 |
| AU2015205620A1 (en) * | 2014-01-09 | 2016-07-14 | Sanofi | Stabilized pharmaceutical formulations of insulin aspart |
-
2014
- 2014-10-23 AR ARP140103985A patent/AR098168A1/es unknown
- 2014-10-23 TW TW103136573A patent/TW201605489A/zh unknown
- 2014-10-24 RU RU2016119746A patent/RU2691059C2/ru not_active IP Right Cessation
- 2014-10-24 US US14/523,842 patent/US20150119323A1/en not_active Abandoned
- 2014-10-24 SG SG11201602939QA patent/SG11201602939QA/en unknown
- 2014-10-24 AU AU2014338863A patent/AU2014338863A1/en not_active Abandoned
- 2014-10-24 KR KR1020167012895A patent/KR20160074562A/ko not_active Withdrawn
- 2014-10-24 HK HK16113873.7A patent/HK1225613A1/zh unknown
- 2014-10-24 CA CA2928320A patent/CA2928320A1/en not_active Abandoned
- 2014-10-24 CN CN201480058603.5A patent/CN105705161A/zh active Pending
- 2014-10-24 MX MX2016005395A patent/MX2016005395A/es unknown
- 2014-10-24 BR BR112016008736A patent/BR112016008736A2/pt not_active Application Discontinuation
- 2014-10-24 SG SG10201803430SA patent/SG10201803430SA/en unknown
- 2014-10-24 WO PCT/EP2014/072915 patent/WO2015059302A1/en not_active Ceased
- 2014-10-24 EP EP14789560.1A patent/EP3060240A1/en not_active Withdrawn
- 2014-10-24 JP JP2016524503A patent/JP6525987B2/ja not_active Expired - Fee Related
-
2016
- 2016-04-14 IL IL245109A patent/IL245109A0/en unknown
- 2016-04-18 PH PH12016500720A patent/PH12016500720A1/en unknown
- 2016-04-21 CL CL2016000950A patent/CL2016000950A1/es unknown
-
2017
- 2017-10-27 US US15/656,839 patent/US20180036411A1/en not_active Abandoned
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