JP2018138578A5 - - Google Patents
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- Publication number
- JP2018138578A5 JP2018138578A5 JP2018079985A JP2018079985A JP2018138578A5 JP 2018138578 A5 JP2018138578 A5 JP 2018138578A5 JP 2018079985 A JP2018079985 A JP 2018079985A JP 2018079985 A JP2018079985 A JP 2018079985A JP 2018138578 A5 JP2018138578 A5 JP 2018138578A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- concentration
- composition according
- insulin
- citrate
- 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 description 56
- 239000000203 mixture Substances 0.000 claims description 22
- 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 description 18
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 9
- 102000004877 Insulin Human genes 0.000 claims description 9
- 108090001061 Insulin Proteins 0.000 claims description 9
- 229940125396 insulin Drugs 0.000 claims description 9
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 8
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims description 8
- 239000011701 zinc Substances 0.000 claims description 8
- 229910052725 zinc Inorganic materials 0.000 claims description 8
- 239000011780 sodium chloride Substances 0.000 claims description 6
- 206010012601 diabetes mellitus Diseases 0.000 claims description 4
- 239000004094 surface-active agent Substances 0.000 claims description 4
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims description 3
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 2
- 108010073961 Insulin Aspart Proteins 0.000 claims description 2
- 239000008280 blood Substances 0.000 claims description 2
- 210000004369 blood Anatomy 0.000 claims description 2
- 229960004717 insulin aspart Drugs 0.000 claims description 2
- 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 claims description 2
- 229920001542 oligosaccharide Polymers 0.000 claims description 2
- 150000002482 oligosaccharides Chemical class 0.000 claims description 2
- 229940124549 vasodilator Drugs 0.000 claims description 2
- 239000003071 vasodilator agent Substances 0.000 claims description 2
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 description 10
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical group CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 description 7
- 229920001993 poloxamer 188 Polymers 0.000 description 7
- 229940044519 poloxamer 188 Drugs 0.000 description 7
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 6
- 108010065920 Insulin Lispro Proteins 0.000 description 6
- WNRQPCUGRUFHED-DETKDSODSA-N humalog 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](CCCCN)C(=O)N1[C@@H](CCC1)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 WNRQPCUGRUFHED-DETKDSODSA-N 0.000 description 6
- 229960002068 insulin lispro Drugs 0.000 description 6
- 229910001629 magnesium chloride Inorganic materials 0.000 description 5
- 229940100630 metacresol Drugs 0.000 description 4
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerol group Chemical group OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- 239000011777 magnesium Substances 0.000 description 3
- 229910052749 magnesium Inorganic materials 0.000 description 3
- 239000003755 preservative agent Substances 0.000 description 3
- 230000002335 preservative effect Effects 0.000 description 3
- 239000003814 drug Substances 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 description 1
- 101500025353 Homo sapiens Insulin A chain Proteins 0.000 description 1
- 101500025354 Homo sapiens Insulin B chain Proteins 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000007951 isotonicity adjuster Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 239000012929 tonicity agent Substances 0.000 description 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462092407P | 2014-12-16 | 2014-12-16 | |
| US62/092,407 | 2014-12-16 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017531725A Division JP6328855B2 (ja) | 2014-12-16 | 2015-12-09 | 即効型インスリン組成物 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020214703A Division JP7159277B2 (ja) | 2014-12-16 | 2020-12-24 | 即効型インスリン組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2018138578A JP2018138578A (ja) | 2018-09-06 |
| JP2018138578A5 true JP2018138578A5 (https=) | 2019-08-15 |
| JP7093669B2 JP7093669B2 (ja) | 2022-06-30 |
Family
ID=55066806
Family Applications (5)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017531725A Active JP6328855B2 (ja) | 2014-12-16 | 2015-12-09 | 即効型インスリン組成物 |
| JP2018079985A Active JP7093669B2 (ja) | 2014-12-16 | 2018-04-18 | 即効型インスリン組成物 |
| JP2020214703A Active JP7159277B2 (ja) | 2014-12-16 | 2020-12-24 | 即効型インスリン組成物 |
| JP2022163910A Pending JP2023011641A (ja) | 2014-12-16 | 2022-10-12 | 即効型インスリン組成物 |
| JP2024199464A Pending JP2025032126A (ja) | 2014-12-16 | 2024-11-15 | 即効型インスリン組成物 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017531725A Active JP6328855B2 (ja) | 2014-12-16 | 2015-12-09 | 即効型インスリン組成物 |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020214703A Active JP7159277B2 (ja) | 2014-12-16 | 2020-12-24 | 即効型インスリン組成物 |
| JP2022163910A Pending JP2023011641A (ja) | 2014-12-16 | 2022-10-12 | 即効型インスリン組成物 |
| JP2024199464A Pending JP2025032126A (ja) | 2014-12-16 | 2024-11-15 | 即効型インスリン組成物 |
Country Status (18)
| Country | Link |
|---|---|
| US (4) | US9993555B2 (https=) |
| EP (2) | EP4108253A1 (https=) |
| JP (5) | JP6328855B2 (https=) |
| AR (1) | AR102869A1 (https=) |
| CY (1) | CY1125275T1 (https=) |
| DK (1) | DK3233108T3 (https=) |
| ES (1) | ES2911207T3 (https=) |
| HR (1) | HRP20220692T1 (https=) |
| HU (1) | HUE058764T2 (https=) |
| LT (1) | LT3233108T (https=) |
| MA (1) | MA41188B1 (https=) |
| MD (1) | MD3233108T2 (https=) |
| PL (1) | PL3233108T3 (https=) |
| PT (1) | PT3233108T (https=) |
| RS (1) | RS63174B1 (https=) |
| SI (1) | SI3233108T1 (https=) |
| TW (1) | TW201630622A (https=) |
| WO (1) | WO2016100042A1 (https=) |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HUE032284T2 (en) | 2008-03-18 | 2017-09-28 | Novo Nordisk As | Protease-stabilized, acylated insulin analogues |
| 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 |
| TW201630622A (zh) * | 2014-12-16 | 2016-09-01 | 美國禮來大藥廠 | 速效胰島素組合物 |
| JO3749B1 (ar) | 2015-08-27 | 2021-01-31 | Lilly Co Eli | تركيبات إنسولين سريعة المفعول |
| GB201607918D0 (en) | 2016-05-06 | 2016-06-22 | Arecor Ltd | Novel formulations |
| JP2019529506A (ja) * | 2016-09-29 | 2019-10-17 | アレコル リミテッド | 新規の製剤 |
| PE20210857A1 (es) | 2016-12-16 | 2021-05-18 | Novo Nordisk As | Composiciones farmaceuticas que contienen insulina |
| US20180236080A1 (en) * | 2017-02-22 | 2018-08-23 | Adocia | Fast-acting insulin composition comprising a citric acid salt |
| CA3056919A1 (en) * | 2017-03-26 | 2018-10-04 | Vivi Robyn Stafford | Method of treatment of skin conditions of eye lids |
| CN110662551B (zh) * | 2017-06-01 | 2023-07-18 | 伊莱利利公司 | 速效胰岛素组合物 |
| US20210113763A1 (en) * | 2018-04-04 | 2021-04-22 | Arecor Limited | Medical infusion pump system for the delivery of an insulin compound |
| US12357562B2 (en) | 2018-04-04 | 2025-07-15 | Arecor Limited | Injection pen system for the delivery of an insulin compound |
| KR102833828B1 (ko) * | 2018-04-04 | 2025-07-15 | 아레콜 리미티드 | 인슐린 화합물의 전달을 위한 의료용 주입 펌프 시스템 |
| FR3083985A1 (fr) | 2018-07-23 | 2020-01-24 | Adocia | Dispositif pour injecter une solution d'insuline(s) |
| WO2019243627A1 (fr) | 2018-06-23 | 2019-12-26 | Adocia | Dispositif pour injecter une solution d'insuline(s) |
| WO2020186154A1 (en) * | 2019-03-14 | 2020-09-17 | The Regents Of The University Of California | Methods and compositions for supporting renal health |
| US10639328B1 (en) * | 2019-03-27 | 2020-05-05 | College Of William & Mary | Compositions and methods for reducing hyperglycemia and treating diabetes |
| US10799564B1 (en) | 2019-05-06 | 2020-10-13 | Baxter International Inc. | Insulin premix formulation and product, methods of preparing same, and methods of using same |
| US20220354782A1 (en) * | 2019-09-17 | 2022-11-10 | Cass Pharmaceuticals, Inc. | Subcutaneously injectable insulin and glucagon formulations and methods of administration |
| EP4049032A1 (en) | 2019-10-25 | 2022-08-31 | Cercacor Laboratories, Inc. | Indicator compounds, devices comprising indicator compounds, and methods of making and using the same |
| IL296090A (en) * | 2020-03-02 | 2022-11-01 | Thermalin Inc | Compositions containing rapid-acting insulin analogues |
| GB202004814D0 (en) | 2020-04-01 | 2020-05-13 | Arecor Ltd | Novel formulations |
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