RU2017146048A - Композиции инсулинов длительного действия - Google Patents
Композиции инсулинов длительного действия Download PDFInfo
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- RU2017146048A RU2017146048A RU2017146048A RU2017146048A RU2017146048A RU 2017146048 A RU2017146048 A RU 2017146048A RU 2017146048 A RU2017146048 A RU 2017146048A RU 2017146048 A RU2017146048 A RU 2017146048A RU 2017146048 A RU2017146048 A RU 2017146048A
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- 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
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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
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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
- A61K38/2278—Vasoactive intestinal peptide [VIP]; Related peptides (e.g. Exendin)
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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
- A61K38/26—Glucagons
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- 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
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- 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
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- 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
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
-
- 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
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- 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
-
- 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
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
-
- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Vascular Medicine (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Emergency Medicine (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
Claims (18)
1. Фармацевтическая композиция на водной основе, содержащая 200-500 Ед/мл инсулина гларгина являющегося эквимолярным 200-500 МЕ человеческого инсулина при условии, что концентрация в указанной композиции не равна 300 ЕД/мл инсулина гларгина и не равна 270-330 ЕД/мл инсулина гларгина.
2. Фармацевтическая композиция на водной основе по п.1, содержащая 200 Ед/мл инсулина гларгина являющегося эквимолярным 200 МЕ человеческого инсулина.
3. Фармацевтическая композиция на водной основе по п.1, содержащая 500 Ед/мл инсулина гларгина являющегося эквимолярным 500 МЕ человеческого инсулина.
4. Фармацевтическая композиция по любому из предшествующих пунктов, содержащая аналог эксендина-4, выбранный из группы, состоящей из ликсисенатида, экзенатида и лираглутидом.
5. Фармацевтическая композиция на водной основе по п.4, содержащая от 0,1 мкг до 10 мкг ликсисенатида на Ед инсулина гларгина.
6. Фармацевтическая композиция на водной основе по п.5, содержащая от 0,2 мкг до 1 мкг ликсисенатида на Ед инсулина гларгина.
7. Фармацевтическая композиция на водной основе по п.6, содержащая от 0,25 мкг до 0,7 мкг ликсисенатида на Ед инсулина гларгина.
8. Фармацевтическая композиция на водной основе по любому из предшествующих пунктов, содержащая один или несколько наполнителей, выбранных из группы, включающей цинк, м-крезол, глицерин, полисорбат 20 и натрий.
9. Фармацевтическая композиция на водной основе по п.8, содержащая 90 мкг/мл цинка, 2,7 мг/мл м-крезола и 20 мг/мл глицерина 85%.
10. Фармацевтическая композиция на водной основе по п.8, содержащая 90 мкг/мл цинка, 2,7 мг/мл м-крезола, 20 мкг/мл полисорбата 20 и 20 мг/мл глицерина 85%.
11. Фармацевтическая композиция на водной основе по любому из предшествующих пунктов, где рН составляет от 3,4 до 4,6.
12. Фармацевтическая композиция на водной основе по п.11, где рН составляет 4.
13. Фармацевтическая композиция на водной основе по п.11, где рН составляет 4,5.
14. Фармацевтическая композиция на водной основе по любому из предшествующих пунктов для лечения сахарного диабета типа I и типа II у пациента.
15. Фармацевтическая композиция на водной основе по любому из предшествующих пунктов для увеличение продолжительности воздействия инсулина длительного действия при лечении сахарного диабета типа I и типа II у пациента.
16. Фармацевтическая композиция на водной основе по любому из предшествующих пунктов для снижения частоты гипогликемии при лечении сахарного диабета типа I и типа II у пациента.
17. Фармацевтическая композиция на водной основе по любому из предшествующих пунктов для обеспечения базального инсулина безпикового длительного действия при лечении типа I и типа II сахарного диабета у пациента.
18. Применение фармацевтической композиции на водной основе по любому из предшествующих пунктов для применения для получения лекарственного средства для лечения сахарного диабета типа I и сахарного диабета типа II.
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10305532.3 | 2010-05-19 | ||
| EP10305532 | 2010-05-19 | ||
| EP10305780 | 2010-07-13 | ||
| EP10305780.8 | 2010-07-13 | ||
| EP11305140.3 | 2011-02-10 | ||
| EP11305140 | 2011-02-10 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015132860A Division RU2642662C2 (ru) | 2010-05-19 | 2015-08-06 | Композиции инсулинов длительного действия |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2022119802A Division RU2022119802A (ru) | 2010-05-19 | 2022-07-20 | Композиции инсулинов длительного действия |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2017146048A true RU2017146048A (ru) | 2019-06-27 |
| RU2017146048A3 RU2017146048A3 (ru) | 2021-07-01 |
Family
ID=44148980
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2011119988/15A RU2564104C2 (ru) | 2010-05-19 | 2011-05-18 | Композиции инсулинов длительного действия |
| RU2015132860A RU2642662C2 (ru) | 2010-05-19 | 2015-08-06 | Композиции инсулинов длительного действия |
| RU2017146048A RU2017146048A (ru) | 2010-05-19 | 2017-12-27 | Композиции инсулинов длительного действия |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2011119988/15A RU2564104C2 (ru) | 2010-05-19 | 2011-05-18 | Композиции инсулинов длительного действия |
| RU2015132860A RU2642662C2 (ru) | 2010-05-19 | 2015-08-06 | Композиции инсулинов длительного действия |
Country Status (43)
Families Citing this family (85)
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| RS56632B1 (sr) | 2008-10-17 | 2018-03-30 | Sanofi Aventis Deutschland | Kombinacija insulina i glp-1-agonista |
| BRPI0919946A2 (pt) | 2008-10-30 | 2016-02-16 | Novo Nordisk As | tratamento de diabetes melito usando injeções de insulina com frequência de injeção menor que diariamente |
| SG177567A1 (en) * | 2009-07-06 | 2012-02-28 | Sanofi Aventis Deutschland | Aqueous insulin preparations containing methionine |
| CN102711804B (zh) | 2009-11-13 | 2015-09-16 | 赛诺菲-安万特德国有限公司 | 包含glp-1激动剂和甲硫氨酸的药物组合物 |
| AU2010317995B2 (en) | 2009-11-13 | 2014-04-17 | Sanofi-Aventis Deutschland Gmbh | Pharmaceutical composition comprising a GLP-1 agonist, an insulin, and methionine |
| AU2011202239C1 (en) | 2010-05-19 | 2017-03-16 | Sanofi | Long-acting formulations of insulins |
| JP6199186B2 (ja) | 2010-08-30 | 2017-09-20 | サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | ２型糖尿病の治療用の医薬の製造のためのａｖｅ００１０の使用 |
| RU2013123515A (ru) | 2010-10-27 | 2014-12-10 | Ново Нордиск А/С | Лечение сахарного диабета с помощью инъекций инсулина, вводимых с различными интервалами |
| CA2825838C (en) | 2011-01-28 | 2020-10-27 | Sanofi | Human antibodies to pcsk9 for use in methods of treating particular groups of subjects |
| US9821032B2 (en) | 2011-05-13 | 2017-11-21 | Sanofi-Aventis Deutschland Gmbh | Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin |
| AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| CA2843586A1 (fr) | 2011-08-10 | 2013-02-14 | Adocia | Solution injectable d'au moins une insuline basale |
| FR2984749A1 (fr) * | 2011-12-23 | 2013-06-28 | Adocia | Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 en combinaison avec une hormone gastro-intestinale a visee therapeutique |
| JP6367115B2 (ja) | 2011-08-29 | 2018-08-01 | サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | ２型糖尿病患者の血糖コントロールに使用する組合せ医薬 |
| TWI559929B (en) | 2011-09-01 | 2016-12-01 | Sanofi Aventis Deutschland | Pharmaceutical composition for use in the treatment of a neurodegenerative disease |
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| FR2985428B1 (fr) * | 2012-01-09 | 2016-05-27 | Adocia | Solution injectable a ph 7 comprenant au moins une insuline basale dont le pi est compris entre 5,8 et 8,5 et un polyaminoacide substitue |
| US9198971B2 (en) | 2012-01-09 | 2015-12-01 | Adocia | Injectable solution at pH 7 comprising at least one basal insulin the pI of which is between 5.8 and 8.5 and a substituted co-polyamino acid |
| GB2513805B (en) * | 2012-04-18 | 2020-04-01 | Waters Technologies Corp | Methods for quantifying polypeptides using mass spectrometry |
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| FR3001896B1 (fr) | 2013-02-12 | 2015-07-03 | Adocia | Solution injectable a ph 7 comprenant au moins une insuline basale dont le point isolectrique est compris entre 5,8 et 8,5 et un polymere anionique hydrophobise |
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| WO2014096985A2 (en) * | 2012-12-19 | 2014-06-26 | Wockhardt Limited | A stable aqueous composition comprising human insulin or an analogue or derivative thereof |
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