CY1121356T1 - Υγρο σκευασμα συζυγους ινσουλινης μακρας δρασης - Google Patents
Υγρο σκευασμα συζυγους ινσουλινης μακρας δρασηςInfo
- Publication number
- CY1121356T1 CY1121356T1 CY20191100288T CY191100288T CY1121356T1 CY 1121356 T1 CY1121356 T1 CY 1121356T1 CY 20191100288 T CY20191100288 T CY 20191100288T CY 191100288 T CY191100288 T CY 191100288T CY 1121356 T1 CY1121356 T1 CY 1121356T1
- Authority
- CY
- Cyprus
- Prior art keywords
- formulation
- insulin
- long
- sponsive
- liquid preparation
- 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 6
- 102000004877 Insulin Human genes 0.000 title abstract 3
- 108090001061 Insulin Proteins 0.000 title abstract 3
- 229940125396 insulin Drugs 0.000 title abstract 3
- 239000007788 liquid Substances 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
- 238000011109 contamination Methods 0.000 abstract 2
- 238000009472 formulation Methods 0.000 abstract 2
- 239000012669 liquid formulation Substances 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 239000003381 stabilizer Substances 0.000 abstract 2
- 102000009027 Albumins Human genes 0.000 abstract 1
- 108010088751 Albumins Proteins 0.000 abstract 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract 1
- 102000008100 Human Serum Albumin Human genes 0.000 abstract 1
- 108091006905 Human Serum Albumin Proteins 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 231100001261 hazardous Toxicity 0.000 abstract 1
- 239000007951 isotonicity adjuster Substances 0.000 abstract 1
- 238000004519 manufacturing process 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
- 230000003612 virological effect Effects 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
- 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
- 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
- A61K47/06—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
- 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
Η παρούσα εφεύρεση αφορά σε ένα υγρό σκεύασμα συζυγούς ινσουλίνης μακράς δράσης, το οποίο περιλαμβάνει μια αποτελεσματική από φαρμακευτική άποψη ποσότητα ενός συζυγούς ινσουλίνης μακράς δράσης, όπου ένα φυσιολογικά δραστικό πεπτίδιο, το οποίο είναι μια ινσουλίνη, συνδέεται με μια περιοχή Fc ανοσοσφαιρίνης, καθώς και έναν χωρίς λευκωματίνη σταθεροποιητή, όπου ο σταθεροποιητής περιλαμβάνει ρυθμιστικό, σακχαρούχο αλκοόλη, μη ιοντικό τασιενεργό και ισοτονικό παράγοντα, καθώς και σε μια μέθοδο για παρασκευή του σκευάσματος. Για πρόληψη της μικροβιακής μόλυνσης σε πολλαπλές χρήσεις, στο σκεύασμα μπορεί να προστίθεται ένα συντηρητικό. Το υγρό σκεύασμα της παρούσας εφεύρεσης δεν περιλαμβάνει λευκωματίνη ανθρώπινου ορού και δυνητικά επικίνδυνους παράγοντες για το σώμα και επομένως έχει άριστη σταθερότητα αποθήκευσης για το συζυγές ινσουλίνης, χωρίς κίνδυνο ιογενούς μόλυνσης.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR20120081477 | 2012-07-25 | ||
PCT/KR2013/006673 WO2014017847A1 (en) | 2012-07-25 | 2013-07-25 | A liquid formulation of long-acting insulin conjugate |
Publications (1)
Publication Number | Publication Date |
---|---|
CY1121356T1 true CY1121356T1 (el) | 2020-05-29 |
Family
ID=49997581
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CY20191100288T CY1121356T1 (el) | 2012-07-25 | 2019-03-12 | Υγρο σκευασμα συζυγους ινσουλινης μακρας δρασης |
Country Status (21)
Country | Link |
---|---|
US (1) | US10987424B2 (el) |
EP (1) | EP2877157B1 (el) |
JP (2) | JP6385925B2 (el) |
KR (1) | KR102088856B1 (el) |
CN (1) | CN104519871B (el) |
AR (1) | AR091902A1 (el) |
AU (1) | AU2013293718B2 (el) |
BR (1) | BR112015001457B1 (el) |
CA (1) | CA2879976C (el) |
CY (1) | CY1121356T1 (el) |
DK (1) | DK2877157T3 (el) |
ES (1) | ES2715326T3 (el) |
HK (1) | HK1207816A1 (el) |
HU (1) | HUE042246T2 (el) |
MX (1) | MX369201B (el) |
PL (1) | PL2877157T3 (el) |
PT (1) | PT2877157T (el) |
RU (1) | RU2670270C2 (el) |
TR (1) | TR201903661T4 (el) |
TW (2) | TWI605824B (el) |
WO (1) | WO2014017847A1 (el) |
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US10842951B2 (en) | 2010-01-12 | 2020-11-24 | Aerami Therapeutics, Inc. | Liquid insulin formulations and methods relating thereto |
US20160243199A1 (en) * | 2015-02-25 | 2016-08-25 | Dance Biopharm, Inc. | Liquid insulin formulations and methods relating thereto |
US9180261B2 (en) | 2010-01-12 | 2015-11-10 | Dance Biopharm Inc. | Preservative free insulin formulations and systems and methods for aerosolizing |
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 |
BR112016016578A2 (pt) | 2014-01-20 | 2017-10-03 | Hanmi Pharm Ind Co Ltd | Insulina de ação prolongada e uso daanálogo de insulina, polinucleotídeo, vetor de expressão, transformante, insulina de ação prolongada bem como seu método de preparação e formulação da mesma, conjugado, e uso do mesmo mesma |
CA2944138C (en) * | 2014-03-31 | 2023-06-20 | Hanmi Pharm. Co., Ltd. | Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage |
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UY36870A (es) | 2015-08-28 | 2017-03-31 | Hanmi Pharm Ind Co Ltd | Análogos de insulina novedosos |
WO2017052329A1 (en) * | 2015-09-24 | 2017-03-30 | Hanmi Pharm. Co., Ltd. | Protein complex by use of a specific site of an immunoglobulin fragment for linkage |
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 |
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EP3604328A4 (en) * | 2017-03-23 | 2021-01-06 | Hanmi Pharm. Co., Ltd. | REDUCED INSULIN ANALOGUE COMPLEX FOR INSULIN RECEPTOR AND ITS USE |
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CN112969449A (zh) | 2018-06-15 | 2021-06-15 | 费灵有限公司 | 特利加压素组合物及其用途 |
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 |
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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 |
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2013
- 2013-07-24 AR ARP130102651A patent/AR091902A1/es unknown
- 2013-07-25 AU AU2013293718A patent/AU2013293718B2/en active Active
- 2013-07-25 EP EP13822348.2A patent/EP2877157B1/en active Active
- 2013-07-25 JP JP2015524184A patent/JP6385925B2/ja active Active
- 2013-07-25 BR BR112015001457-7A patent/BR112015001457B1/pt active IP Right Grant
- 2013-07-25 HU HUE13822348A patent/HUE042246T2/hu unknown
- 2013-07-25 WO PCT/KR2013/006673 patent/WO2014017847A1/en active Application Filing
- 2013-07-25 MX MX2015000988A patent/MX369201B/es active IP Right Grant
- 2013-07-25 ES ES13822348T patent/ES2715326T3/es active Active
- 2013-07-25 KR KR1020130087909A patent/KR102088856B1/ko active IP Right Grant
- 2013-07-25 CA CA2879976A patent/CA2879976C/en active Active
- 2013-07-25 TW TW102126620A patent/TWI605824B/zh not_active IP Right Cessation
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- 2013-07-25 PL PL13822348T patent/PL2877157T3/pl unknown
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- 2013-07-25 RU RU2015104495A patent/RU2670270C2/ru active
- 2013-07-25 TW TW106135078A patent/TW201803587A/zh unknown
- 2013-07-25 CN CN201380039653.4A patent/CN104519871B/zh active Active
- 2013-07-25 DK DK13822348.2T patent/DK2877157T3/en active
- 2013-07-25 TR TR2019/03661T patent/TR201903661T4/tr unknown
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2015
- 2015-07-07 HK HK15106482.5A patent/HK1207816A1/xx unknown
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2018
- 2018-04-18 JP JP2018079838A patent/JP6682570B2/ja active Active
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2019
- 2019-03-12 CY CY20191100288T patent/CY1121356T1/el unknown
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