KR20240082407A - 보존된 제제 - Google Patents
보존된 제제 Download PDFInfo
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- KR20240082407A KR20240082407A KR1020247015596A KR20247015596A KR20240082407A KR 20240082407 A KR20240082407 A KR 20240082407A KR 1020247015596 A KR1020247015596 A KR 1020247015596A KR 20247015596 A KR20247015596 A KR 20247015596A KR 20240082407 A KR20240082407 A KR 20240082407A
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- KR
- South Korea
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- composition
- bif
- insulin
- phenol
- Prior art date
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- PYLIXCKOHOHGKQ-UHFFFAOYSA-L disodium;hydrogen phosphate;heptahydrate Chemical compound O.O.O.O.O.O.O.[Na+].[Na+].OP([O-])([O-])=O PYLIXCKOHOHGKQ-UHFFFAOYSA-L 0.000 description 1
- 239000000975 dye Substances 0.000 description 1
- 238000000295 emission spectrum Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000005284 excitation Effects 0.000 description 1
- 238000002795 fluorescence method Methods 0.000 description 1
- 238000002189 fluorescence spectrum Methods 0.000 description 1
- 239000013022 formulation composition Substances 0.000 description 1
- 108020001507 fusion proteins Proteins 0.000 description 1
- 102000037865 fusion proteins Human genes 0.000 description 1
- 230000009229 glucose formation Effects 0.000 description 1
- 230000008642 heat stress Effects 0.000 description 1
- 230000002440 hepatic effect Effects 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 230000002218 hypoglycaemic effect Effects 0.000 description 1
- 239000000859 incretin Substances 0.000 description 1
- MGXWVYUBJRZYPE-YUGYIWNOSA-N incretin Chemical class C([C@@H](C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCC(N)=O)C(O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1C=CC(O)=CC=1)[C@@H](C)O)[C@@H](C)CC)C1=CC=C(O)C=C1 MGXWVYUBJRZYPE-YUGYIWNOSA-N 0.000 description 1
- 238000011081 inoculation Methods 0.000 description 1
- 239000002054 inoculum Substances 0.000 description 1
- 230000003914 insulin secretion Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 229940070765 laurate Drugs 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 239000012569 microbial contaminant Substances 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 208000035824 paresthesia Diseases 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 239000003495 polar organic solvent Substances 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 229920001992 poloxamer 407 Polymers 0.000 description 1
- 229940044476 poloxamer 407 Drugs 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920001451 polypropylene glycol Polymers 0.000 description 1
- 229940068965 polysorbates Drugs 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000012514 protein characterization Methods 0.000 description 1
- 230000012846 protein folding Effects 0.000 description 1
- 239000012460 protein solution Substances 0.000 description 1
- 230000006432 protein unfolding Effects 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 230000002277 temperature effect Effects 0.000 description 1
- 239000012085 test solution Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000004448 titration Methods 0.000 description 1
- 229940110253 toujeo Drugs 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 238000011269 treatment regimen Methods 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- GPRLSGONYQIRFK-MNYXATJNSA-N triton Chemical compound [3H+] GPRLSGONYQIRFK-MNYXATJNSA-N 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000011179 visual inspection Methods 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
Classifications
-
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Gastroenterology & Hepatology (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Zoology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163279390P | 2021-11-15 | 2021-11-15 | |
| US63/279,390 | 2021-11-15 | ||
| PCT/US2022/079791 WO2023086980A1 (en) | 2021-11-15 | 2022-11-14 | Preserved formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| KR20240082407A true KR20240082407A (ko) | 2024-06-10 |
Family
ID=84537390
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020247015596A Pending KR20240082407A (ko) | 2021-11-15 | 2022-11-14 | 보존된 제제 |
Country Status (19)
| Country | Link |
|---|---|
| US (1) | US20250000950A1 (https=) |
| EP (1) | EP4433024A1 (https=) |
| JP (1) | JP2024543457A (https=) |
| KR (1) | KR20240082407A (https=) |
| CN (1) | CN118302152A (https=) |
| AR (1) | AR127619A1 (https=) |
| AU (1) | AU2022386352B2 (https=) |
| CA (1) | CA3238180A1 (https=) |
| CL (1) | CL2024001415A1 (https=) |
| CO (1) | CO2024006121A2 (https=) |
| CR (1) | CR20240202A (https=) |
| DO (1) | DOP2024000084A (https=) |
| EC (1) | ECSP24036789A (https=) |
| IL (1) | IL312623A (https=) |
| JO (1) | JOP20240108A1 (https=) |
| MX (1) | MX2024005879A (https=) |
| PE (1) | PE20241354A1 (https=) |
| TW (1) | TWI871539B (https=) |
| WO (1) | WO2023086980A1 (https=) |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8097584B2 (en) * | 2005-05-25 | 2012-01-17 | Novo Nordisk A/S | Stabilized formulations of insulin that comprise ethylenediamine |
| AR081066A1 (es) | 2010-04-02 | 2012-06-06 | Hanmi Holdings Co Ltd | Conjugado de insulina donde se usa un fragmento de inmunoglobulina |
| US20130011378A1 (en) * | 2011-06-17 | 2013-01-10 | Tzung-Horng Yang | Stable formulations of a hyaluronan-degrading enzyme |
| CN103509118B (zh) | 2012-06-15 | 2016-03-23 | 郭怀祖 | 胰岛素-Fc融合蛋白 |
| AR091902A1 (es) * | 2012-07-25 | 2015-03-11 | Hanmi Pharm Ind Co Ltd | Formulacion liquida de un conjugado de insulina de accion prolongada |
| AR105616A1 (es) * | 2015-05-07 | 2017-10-25 | Lilly Co Eli | Proteínas de fusión |
| JP2020513019A (ja) | 2017-04-05 | 2020-04-30 | ノヴォ ノルディスク アー／エス | オリゴマー伸長インスリン−Ｆｃコンジュゲート |
| KR20210029210A (ko) | 2018-06-29 | 2021-03-15 | 악스톤 바이오사이언시스 코퍼레이션 | 초장기 작용 인슐린-fc 융합 단백질 및 사용 방법 |
| WO2020074544A1 (en) | 2018-10-10 | 2020-04-16 | Novo Nordisk A/S | Oligomer extended insulin-fc conjugates and their medical use |
| US20220354782A1 (en) * | 2019-09-17 | 2022-11-10 | Cass Pharmaceuticals, Inc. | Subcutaneously injectable insulin and glucagon formulations and methods of administration |
| WO2021119607A1 (en) * | 2019-12-13 | 2021-06-17 | The Board Of Trustees Of The Leland Stanford Junior University | Stable monomeric insulin formulations enabled by supramolecular pegylation of insulin analogues |
| KR20250142943A (ko) | 2019-12-19 | 2025-09-30 | 악스톤 바이오사이언시스 코퍼레이션 | 초-장기 작용 인슐린-fc 융합 단백질 및 사용 방법 |
| US11186623B2 (en) | 2019-12-24 | 2021-11-30 | Akston Bioscience Corporation | Ultra-long acting insulin-Fc fusion proteins and methods of use |
| US11192930B2 (en) | 2020-04-10 | 2021-12-07 | Askton Bioscences Corporation | Ultra-long acting insulin-Fc fusion protein and methods of use |
| US11198719B2 (en) | 2020-04-29 | 2021-12-14 | Akston Biosciences Corporation | Ultra-long acting insulin-Fc fusion protein and methods of use |
-
2022
- 2022-11-09 TW TW111142719A patent/TWI871539B/zh active
- 2022-11-09 AR ARP220103074A patent/AR127619A1/es unknown
- 2022-11-14 PE PE2024001075A patent/PE20241354A1/es unknown
- 2022-11-14 CA CA3238180A patent/CA3238180A1/en active Pending
- 2022-11-14 US US18/709,721 patent/US20250000950A1/en active Pending
- 2022-11-14 IL IL312623A patent/IL312623A/en unknown
- 2022-11-14 CN CN202280075570.XA patent/CN118302152A/zh active Pending
- 2022-11-14 JP JP2024527771A patent/JP2024543457A/ja active Pending
- 2022-11-14 CR CR20240202A patent/CR20240202A/es unknown
- 2022-11-14 KR KR1020247015596A patent/KR20240082407A/ko active Pending
- 2022-11-14 EP EP22826289.5A patent/EP4433024A1/en active Pending
- 2022-11-14 AU AU2022386352A patent/AU2022386352B2/en active Active
- 2022-11-14 WO PCT/US2022/079791 patent/WO2023086980A1/en not_active Ceased
- 2022-11-14 MX MX2024005879A patent/MX2024005879A/es unknown
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2024
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- 2024-05-15 EC ECSENADI202436789A patent/ECSP24036789A/es unknown
- 2024-05-15 CO CONC2024/0006121A patent/CO2024006121A2/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| TW202339790A (zh) | 2023-10-16 |
| JOP20240108A1 (ar) | 2024-05-14 |
| ECSP24036789A (es) | 2024-06-28 |
| PE20241354A1 (es) | 2024-07-03 |
| MX2024005879A (es) | 2024-05-29 |
| CR20240202A (es) | 2024-06-11 |
| CL2024001415A1 (es) | 2024-10-18 |
| CN118302152A (zh) | 2024-07-05 |
| DOP2024000084A (es) | 2024-06-16 |
| EP4433024A1 (en) | 2024-09-25 |
| AU2022386352A1 (en) | 2024-05-09 |
| AR127619A1 (es) | 2024-02-14 |
| IL312623A (en) | 2024-07-01 |
| JP2024543457A (ja) | 2024-11-21 |
| US20250000950A1 (en) | 2025-01-02 |
| WO2023086980A1 (en) | 2023-05-19 |
| CO2024006121A2 (es) | 2024-06-27 |
| AU2022386352B2 (en) | 2025-12-18 |
| TWI871539B (zh) | 2025-02-01 |
| CA3238180A1 (en) | 2023-05-19 |
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Legal Events
| Date | Code | Title | Description |
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| PA0105 | International application |
Patent event date: 20240510 Patent event code: PA01051R01D Comment text: International Patent Application |
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| PA0201 | Request for examination | ||
| PG1501 | Laying open of application |