RU2019118696A - Фармацевтические композиции, содержащие инсулин - Google Patents
Фармацевтические композиции, содержащие инсулин Download PDFInfo
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- 239000008194 pharmaceutical composition Substances 0.000 title claims 16
- 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 title claims 12
- 102000004877 Insulin Human genes 0.000 title 1
- 108090001061 Insulin Proteins 0.000 title 1
- 229940125396 insulin Drugs 0.000 title 1
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 10
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 10
- 239000004026 insulin derivative Substances 0.000 claims 10
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims 10
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 7
- 101000976075 Homo sapiens Insulin Proteins 0.000 claims 5
- PTFCDOFLOPIGGS-UHFFFAOYSA-N Zinc dication Chemical compound [Zn+2] PTFCDOFLOPIGGS-UHFFFAOYSA-N 0.000 claims 5
- 235000011187 glycerol Nutrition 0.000 claims 5
- 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 claims 5
- 239000011780 sodium chloride Substances 0.000 claims 5
- DLSWIYLPEUIQAV-UHFFFAOYSA-N Semaglutide Chemical compound CCC(C)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CCC(O)=O)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCC(O)=O)C(O)=O)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(O)=O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(O)=O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(O)=O)NC(=O)C(C)(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CCCNC(N)=N)C(=O)NCC(O)=O DLSWIYLPEUIQAV-UHFFFAOYSA-N 0.000 claims 2
- 229940125904 compound 1 Drugs 0.000 claims 2
- 229950011186 semaglutide Drugs 0.000 claims 2
- 108010060325 semaglutide Proteins 0.000 claims 2
- 229940125782 compound 2 Drugs 0.000 claims 1
- 229940126214 compound 3 Drugs 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 208000030159 metabolic disease Diseases 0.000 claims 1
Classifications
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- 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
- A61K38/28—Insulins
-
- 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
- A61K38/26—Glucagons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Diabetes (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Child & Adolescent Psychology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Manipulator (AREA)
Claims (39)
1. Фармацевтическая композиция, содержащая производное инсулина, выбранное из группы, состоящей из
человеческого инсулина А14Е, В16Н, В25Н, В29K((Nεэйкозандиоил-γGlu-[2-(2-{2-[2-(2-аминоэтокси)этокси]ацетиламино}этокси)этокси]ацетил)), desB30 (соединение 1);
человеческого инсулина А14Е, В16Н, В25Н, В29K(Nεгексадекандиоил-γGlu), desB30 (соединение 2);
человеческого инсулина А14Е, В16Н, В25Н, В29K(Nε-эйкозандиоил-γGlu), desB30 (соединение 3) и
человеческого инсулина А14Е, В25Н, desB27, В29K(Nε-октадекандиоил-γGlu), desB30 (соединение 4); и дополнительно содержащая
от приблизительно 1 до приблизительно 2% (вес/вес) глицерина; от приблизительно 45 до приблизительно 75 мМ фенола; от приблизительно 0 до приблизительно 19 мМ м-крезола; от приблизительно 1,5 до приблизительно 2,5 моль ионов цинка на шесть молей указанного производного инсулина; не более приблизительно 75 мМ хлорида натрия, и которая характеризуется значением рН в диапазоне от 7,2 до 8,0.
2. Фармацевтическая композиция по п. 1, где производное инсулина представляет собой человеческий инсулин А14Е, В16Н, В25Н, B29K((Nε-эйкозандиоил-γGlu-[2-(2-{2-[2-(2-аминоэтокси)этокси]ацетиламино}этокси)этокси]ацетил)), desB30 (соединение 1).
3. Фармацевтическая композиция по любому из пп. 1, 2, где количество производного инсулина находится в диапазоне от приблизительно 3,5 до приблизительно 5,0 мМ.
4. Фармацевтическая композиция по любому из пп. 1, 2, содержащая от приблизительно 1 до приблизительно 2% (вес/вес) глицерина.
5. Фармацевтическая композиция по любому из пп. 1, 2, содержащая от приблизительно 45 до приблизительно 75 мМ фенола, например от приблизительно 55 мМ до приблизительно 65 мМ фенола, или содержащая 50 мМ, 51 мМ, 52 мМ, 53 мМ, 54 мМ, 55 мМ, 56 мМ, 57 мМ, 58 мМ, 59 мМ, 60 мМ, 61 мМ, 62 мМ, 63 мМ, 64 мМ, 65 мМ, 66 мМ, 67 мМ, 68 мМ, 69 мМ или 70 мМ фенола.
6. Фармацевтическая композиция по любому из пп. 1, 2, содержащая от приблизительно 0 до приблизительно 19 мМ м-крезола, например от приблизительно 0 мМ до приблизительно 15 мМ м-крезола, или содержащая 0 мМ, 1 мМ, 2 мМ, 3 мМ, 4 мМ, 5 мМ, 6 мМ, 7 мМ, 8 мМ, 9 мМ, 10 мМ, 11 мМ, 12 мМ, 13 мМ, 14 мМ или 15 мМ м-крезола.
7. Фармацевтическая композиция по любому из пп. 1, 2, содержащая от приблизительно 1,5 до приблизительно 2,5 моль ионов цинка на шесть молей производного инсулина.
8. Фармацевтическая композиция по любому из пп. 1, 2, содержащая менее приблизительно 25 мМ хлорида натрия.
9. Фармацевтическая композиция по любому из пп. 1, 2, характеризующаяся значением рН в диапазоне от 7,2 до 8,0.
10. Фармацевтическая композиция по любому из пп. 1, 2, содержащая
от приблизительно 4,0 до приблизительно 4,5 мМ производного инсулина;
от приблизительно 1 до приблизительно 2% (вес/вес) глицерина;
от приблизительно 50 до приблизительно 70 мМ фенола;
от приблизительно 0 до приблизительно 15 мМ м-крезола; от приблизительно 2,0 до приблизительно 2,5 моль ионов цинка на шесть молей производного инсулина;
не более приблизительно 25 мМ хлорида натрия и
характеризующаяся значением рН в диапазоне от 7,2 до 7,6.
11. Фармацевтическая композиция по любому из пп. 1, 2, содержащая
приблизительно 4,2 мМ производного иулина; нс
приблизительно 1,5% (вес/вес) глицерина;
приблизительно 60 мМ фенола;
приблизительно 0 мМ м-крезола;
приблизительно 2,2 моль ионов цинка на шесть молей производного инсулина;
приблизительно 20 мМ хлорида натрия и
характеризующаяся значением рН приблизительно 7,4.
12. Фармацевтическая композиция по любому из пп. 1, 2, содержащая
приблизительно 4,2 мМ производного инсулина;
приблизительно 1,5% (вес/вес) глицерина;
приблизительно 60 мМ фенола;
приблизительно 10 мМ м-крезола;
приблизительно 2,2 моль ионов цинка на шесть молей производного инсулина;
приблизительно 20 мМ хлорида натрия и характеризующаяся значением рН приблизительно 7,4.
13. Фармацевтическая композиция по любому из предыдущих пунктов, дополнительно содержащая семаглутид.
14. Фармацевтическая композиция по п. 13, где количество семаглутида находится в диапазоне от приблизительно 0,30 до приблизительно 0,70 мМ.
15. Фармацевтическая композиция по п. 1 для применения в качестве лекарственного препарата для лечения метаболического расстройства.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16204688.2 | 2016-12-16 | ||
| EP16204688 | 2016-12-16 | ||
| PCT/EP2017/083013 WO2018109162A1 (en) | 2016-12-16 | 2017-12-15 | Insulin containing pharmaceutical compositions |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2019118696A true RU2019118696A (ru) | 2021-01-18 |
| RU2019118696A3 RU2019118696A3 (ru) | 2021-03-19 |
| RU2758367C2 RU2758367C2 (ru) | 2021-10-28 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2019118696A RU2758367C2 (ru) | 2016-12-16 | 2017-12-15 | Фармацевтические композиции, содержащие инсулин |
Country Status (28)
| Country | Link |
|---|---|
| US (5) | US20180169190A1 (ru) |
| EP (2) | EP3554534B1 (ru) |
| JP (2) | JP6690062B2 (ru) |
| KR (2) | KR102580007B1 (ru) |
| CN (2) | CN115154591B (ru) |
| AU (2) | AU2017378102B2 (ru) |
| BR (1) | BR112019011761A2 (ru) |
| CA (1) | CA3046583A1 (ru) |
| CL (1) | CL2019001586A1 (ru) |
| CO (1) | CO2019006017A2 (ru) |
| DK (2) | DK3554534T3 (ru) |
| ES (2) | ES2886837T3 (ru) |
| HR (2) | HRP20221324T1 (ru) |
| HU (2) | HUE055231T2 (ru) |
| IL (2) | IL267224B2 (ru) |
| MA (1) | MA49116A (ru) |
| MX (2) | MX2019006463A (ru) |
| MY (1) | MY194504A (ru) |
| PE (2) | PE20191205A1 (ru) |
| PH (1) | PH12019501363A1 (ru) |
| PL (2) | PL3554534T3 (ru) |
| PT (1) | PT3554534T (ru) |
| RS (2) | RS63773B1 (ru) |
| RU (1) | RU2758367C2 (ru) |
| SA (1) | SA520420276B1 (ru) |
| SI (1) | SI3554534T1 (ru) |
| TW (2) | TWI700091B (ru) |
| WO (1) | WO2018109162A1 (ru) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2254906T3 (pl) | 2008-03-18 | 2017-04-28 | Novo Nordisk A/S | Stabilizowane względem proteaz, acylowane analogi insuliny |
| EP3554534B1 (en) | 2016-12-16 | 2021-06-23 | Novo Nordisk A/S | Insulin containing pharmaceutical compositions |
| CA3122637A1 (en) | 2018-12-11 | 2020-06-18 | Sanofi | Peptide binder |
| KR20220112817A (ko) | 2019-12-10 | 2022-08-11 | 사노피 | 설폰아미드 및 폴리펩티드의 콘주게이트를 형성하는 방법 |
| KR20220121833A (ko) * | 2019-12-30 | 2022-09-01 | 간 앤 리 파마슈티칼스 컴퍼니, 리미티드 | 인슐린 유도체 |
| AU2022300061A1 (en) * | 2021-06-25 | 2024-02-01 | Gan & Lee Pharmaceuticals Co., Ltd. | Acylated insulin-containing pharmaceutical composition |
| JP7437833B1 (ja) | 2023-09-21 | 2024-02-26 | 俊二 二宮 | 検体検査用のカラー濾紙及びその製造方法 |
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