AR091902A1 - Formulacion liquida de un conjugado de insulina de accion prolongada - Google Patents
Formulacion liquida de un conjugado de insulina de accion prolongadaInfo
- Publication number
- AR091902A1 AR091902A1 ARP130102651A ARP130102651A AR091902A1 AR 091902 A1 AR091902 A1 AR 091902A1 AR P130102651 A ARP130102651 A AR P130102651A AR P130102651 A ARP130102651 A AR P130102651A AR 091902 A1 AR091902 A1 AR 091902A1
- Authority
- AR
- Argentina
- Prior art keywords
- insulin conjugate
- liquid formulation
- formulation
- long
- prolonged insulin
- Prior art date
Links
- 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 abstract 4
- 102000004877 Insulin Human genes 0.000 title abstract 2
- 108090001061 Insulin Proteins 0.000 title abstract 2
- 229940125396 insulin Drugs 0.000 title abstract 2
- 239000012669 liquid formulation Substances 0.000 title abstract 2
- 230000002035 prolonged effect Effects 0.000 title 1
- 102000016261 Long-Acting Insulin Human genes 0.000 abstract 2
- 108010092217 Long-Acting Insulin Proteins 0.000 abstract 2
- 229940100066 Long-acting insulin Drugs 0.000 abstract 2
- 238000009472 formulation Methods 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 108060003951 Immunoglobulin Proteins 0.000 abstract 1
- 239000007853 buffer solution Substances 0.000 abstract 1
- 238000011109 contamination Methods 0.000 abstract 1
- 102000018358 immunoglobulin Human genes 0.000 abstract 1
- 239000007951 isotonicity adjuster Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 230000000813 microbial effect Effects 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- 239000003755 preservative agent Substances 0.000 abstract 1
- 230000002335 preservative effect Effects 0.000 abstract 1
- 108090000765 processed proteins & peptides Proteins 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 150000005846 sugar alcohols Chemical class 0.000 abstract 1
Classifications
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- 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
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
-
- 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
- A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Inorganic Chemistry (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Abstract
Una formulación líquida de un conjugado de insulina de acción prolongada que comprende una cantidad farmacéuticamente eficaz de un conjugado de insulina de acción prolongada, en el cual un péptido fisiológicamente activo, que es una insulina, se encuentra unido a la región Fc de una inmunoglobulina, y comprende además un estabilizador libre de albúmina que comprende una solución amortiguadora, un alcohol de azúcar, un tensioactivo no iónico, y un agente isotónico. Método para preparar la formulación. Además, para impedir la contaminación microbiana en múltiples usos, se puede agregar un conservante a la formulación.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20120081477 | 2012-07-25 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR091902A1 true AR091902A1 (es) | 2015-03-11 |
Family
ID=49997581
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP130102651A AR091902A1 (es) | 2012-07-25 | 2013-07-24 | Formulacion liquida de un conjugado de insulina de accion prolongada |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US10987424B2 (es) |
| EP (1) | EP2877157B1 (es) |
| JP (2) | JP6385925B2 (es) |
| KR (1) | KR102088856B1 (es) |
| CN (1) | CN104519871B (es) |
| AR (1) | AR091902A1 (es) |
| AU (1) | AU2013293718B2 (es) |
| BR (1) | BR112015001457B1 (es) |
| CA (1) | CA2879976C (es) |
| CY (1) | CY1121356T1 (es) |
| DK (1) | DK2877157T3 (es) |
| ES (1) | ES2715326T3 (es) |
| HU (1) | HUE042246T2 (es) |
| MX (1) | MX369201B (es) |
| PL (1) | PL2877157T3 (es) |
| PT (1) | PT2877157T (es) |
| RU (1) | RU2670270C2 (es) |
| TR (1) | TR201903661T4 (es) |
| TW (2) | TW201803587A (es) |
| WO (1) | WO2014017847A1 (es) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9180261B2 (en) | 2010-01-12 | 2015-11-10 | Dance Biopharm Inc. | Preservative free insulin formulations and systems and methods for aerosolizing |
| US10842951B2 (en) | 2010-01-12 | 2020-11-24 | Aerami Therapeutics, Inc. | Liquid insulin formulations and methods relating thereto |
| KR20130049671A (ko) | 2011-11-04 | 2013-05-14 | 한미사이언스 주식회사 | 생리활성 폴리펩타이드 결합체 제조 방법 |
| AR090281A1 (es) | 2012-03-08 | 2014-10-29 | Hanmi Science Co Ltd | Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo |
| AR091902A1 (es) * | 2012-07-25 | 2015-03-11 | Hanmi Pharm Ind Co Ltd | Formulacion liquida de un conjugado de insulina de accion prolongada |
| US10253082B2 (en) | 2014-01-20 | 2019-04-09 | Hanmi Pharm. Co., Ltd | Long-acting insulin and use thereof |
| MY192248A (en) * | 2014-03-31 | 2022-08-10 | Hanmi Pharm Ind Co Ltd | Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage |
| AR100639A1 (es) | 2014-05-29 | 2016-10-19 | Hanmi Pharm Ind Co Ltd | Composición para tratar diabetes que comprende conjugados de análogos de insulina de acción prolongada y conjugados de péptidos insulinotrópicos de acción prolongada |
| TWI684458B (zh) | 2014-05-30 | 2020-02-11 | 南韓商韓美藥品股份有限公司 | 包含胰島素及ｇｌｐ-１/昇糖素雙重促效劑之治療糖尿病之組成物 |
| CN107810202A (zh) * | 2015-02-17 | 2018-03-16 | 韩美药品株式会社 | 长效胰岛素或胰岛素类似物复合物 |
| CN107530372A (zh) * | 2015-02-25 | 2018-01-02 | 当斯生物制药有限公司 | 液体胰岛素制剂及与其相关的方法 |
| AR105616A1 (es) | 2015-05-07 | 2017-10-25 | Lilly Co Eli | Proteínas de fusión |
| UY36870A (es) | 2015-08-28 | 2017-03-31 | Hanmi Pharm Ind Co Ltd | Análogos de insulina novedosos |
| EP3341025A4 (en) * | 2015-09-24 | 2019-05-01 | Hanmi Pharm. Co., Ltd. | PROTEIN COMPLEX BY USING A SPECIFIC ROLE OF AN IMMUNOMOBILIN FRAGMENT FOR LINKING |
| CN105597087B (zh) * | 2016-01-06 | 2019-04-26 | 山东新时代药业有限公司 | 一种甘精胰岛素注射液及其制备方法 |
| GB201607918D0 (en) | 2016-05-06 | 2016-06-22 | Arecor Ltd | Novel formulations |
| US11396534B2 (en) | 2016-09-23 | 2022-07-26 | Hanmi Pharm. Co., Ltd. | Insulin analogs with reduced affinity to insulin receptor and use thereof |
| WO2018174668A2 (ko) | 2017-03-23 | 2018-09-27 | 한미약품 주식회사 | 인슐린 수용체와의 결합력이 감소된 인슐린 아날로그의 결합체 및 이의 용도 |
| WO2019066603A1 (ko) * | 2017-09-29 | 2019-04-04 | 한미약품 주식회사 | 효력이 향상된 지속성 단백질 결합체 |
| JP7523775B2 (ja) * | 2018-06-15 | 2024-07-29 | フェリング ベスローテン フェンノートシャップ | テルリプレシン組成物及びその使用 |
| TWI844709B (zh) * | 2019-07-31 | 2024-06-11 | 美商美國禮來大藥廠 | 鬆弛素(relaxin)類似物及其使用方法 |
| PY2116992A (es) * | 2020-02-27 | 2022-04-05 | Aic246 Gmbh & Co Kg | 2-[(4s)-8-fluoro-2-[4-(3-metoxifenil)piperazin-1-il]-3-[2-metoxi-5-(trifluorometil)fenil]-4h-quinazolin-4-il] acetato de sodio y composiciones farmacéuticas del mismo |
| TWI871539B (zh) * | 2021-11-15 | 2025-02-01 | 美商美國禮來大藥廠 | 可保存之調配物 |
| WO2025089468A1 (ko) * | 2023-10-27 | 2025-05-01 | 주식회사 엔솔바이오사이언스 | 펩타이드 함유 액상제제 및 그 제조방법 |
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| AU728657B2 (en) | 1996-03-18 | 2001-01-18 | Board Of Regents, The University Of Texas System | Immunoglobulin-like domains with increased half-lives |
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| KR101135244B1 (ko) | 2007-11-29 | 2012-04-24 | 한미사이언스 주식회사 | 인슐린 분비 펩타이드 결합체를 포함하는 비만 관련질환 치료용 조성물 |
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| TWI505834B (zh) * | 2009-06-22 | 2015-11-01 | Wyeth Llc | 組合物及製備金黃色葡萄球菌血清型５及８莢膜多醣結合物之免疫原性組合物之方法 |
| AU2011207916B2 (en) * | 2010-01-19 | 2014-01-23 | Hanmi Science Co., Ltd. | Liquid formulations for long-acting erythropoietin conjugate |
| AR081066A1 (es) * | 2010-04-02 | 2012-06-06 | Hanmi Holdings Co Ltd | Conjugado de insulina donde se usa un fragmento de inmunoglobulina |
| KR101324828B1 (ko) | 2010-06-08 | 2013-11-01 | 한미사이언스 주식회사 | 면역글로불린 단편을 이용한 단쇄 인슐린 아날로그 약물 결합체 |
| KR101330868B1 (ko) * | 2010-06-08 | 2013-11-18 | 한미사이언스 주식회사 | 면역글로불린 단편을 이용한 인슐린 유도체 약물 결합체 |
| KR101337797B1 (ko) | 2010-07-14 | 2013-12-06 | 한미사이언스 주식회사 | 지속형 인간 성장 호르몬 결합체 액상 제제 |
| KR101303388B1 (ko) * | 2010-10-26 | 2013-09-03 | 한미사이언스 주식회사 | 지속형 인터페론 알파 결합체의 액상 제제 |
| AR091902A1 (es) | 2012-07-25 | 2015-03-11 | Hanmi Pharm Ind Co Ltd | Formulacion liquida de un conjugado de insulina de accion prolongada |
-
2013
- 2013-07-24 AR ARP130102651A patent/AR091902A1/es unknown
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2018
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2019
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