RU2012123739A - Фармацевтическая композиция, содержащая агонист гпп-1 и метионин - Google Patents
Фармацевтическая композиция, содержащая агонист гпп-1 и метионин Download PDFInfo
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- RU2012123739A RU2012123739A RU2012123739/15A RU2012123739A RU2012123739A RU 2012123739 A RU2012123739 A RU 2012123739A RU 2012123739/15 A RU2012123739/15 A RU 2012123739/15A RU 2012123739 A RU2012123739 A RU 2012123739A RU 2012123739 A RU2012123739 A RU 2012123739A
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- A61K9/00—Medicinal preparations characterised by special physical form
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- 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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- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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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
- A61K9/0012—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
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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Abstract
1. Жидкая композиция, содержащая агонист ГПП-1 или/и его фармакологически приемлемую соль и, необязательно, по меньшей мере один фармакологически приемлемый эксципиент, отличающаяся тем, что композиция содержит метионин.2. Жидкая композиция по п.1, отличающаяся тем, что она содержит фармакологически приемлемый консервант, в частности, м-крезол.3. Жидкая композиция по п.1 или 2, отличающаяся тем, что она содержит глицерин.4. Жидкая композиция по п.1, отличающаяся тем, что она имеет pH в диапазоне от 3,5 до 5.5. Жидкая композиция по п.1, отличающаяся тем, что она содержит метионин в количестве от 0,5 мг/мл до 20 мг/мл, предпочтительно от 1 мг/мл до 5 мг/мл.6. Жидкая композиция по п.1, отличающаяся тем, что она проявляет химическую целостность после хранения в течение 6 месяцев при температуре +25°C.7. Жидкая композиция по п.1, отличающаяся тем, что она проявляет физическую целостность после хранения в течение 6 месяцев при температуре +25°C.8. Жидкая композиция по п.1, отличающаяся тем, что агонист ГПП-1 выбран из группы, состоящей из ГПП-1 и его аналогов и производных, эксендина-3 и его аналогов и производных, эксендина-4 и его аналогов и производных, причем агонист ГПП-1 предпочтительно выбран из группы, состоящей из desProэксендин-4(1-39)-Lys-NHи эксендина-4.9. Жидкая композиция по п.1, отличающаяся тем, что она содержит следующие компоненты:(a) desProэксендин-4(1-39)-Lys-NH,(b) ацетат натрия,(c) м-крезол,(d) L-метионин,(e) 85%-ый глицерин,(f) соляную кислоту примерно 0,1 н, если требуется установить pH примерно 4,5,(g) раствор NaOH примерно 0,1 н, если требуется установить pH примерно 4,5, и(h) воду.10. Композиция по п.1, отличающаяся тем, что она является композицией, годной для инъекций.11. Компози
Claims (26)
1. Жидкая композиция, содержащая агонист ГПП-1 или/и его фармакологически приемлемую соль и, необязательно, по меньшей мере один фармакологически приемлемый эксципиент, отличающаяся тем, что композиция содержит метионин.
2. Жидкая композиция по п.1, отличающаяся тем, что она содержит фармакологически приемлемый консервант, в частности, м-крезол.
3. Жидкая композиция по п.1 или 2, отличающаяся тем, что она содержит глицерин.
4. Жидкая композиция по п.1, отличающаяся тем, что она имеет pH в диапазоне от 3,5 до 5.
5. Жидкая композиция по п.1, отличающаяся тем, что она содержит метионин в количестве от 0,5 мг/мл до 20 мг/мл, предпочтительно от 1 мг/мл до 5 мг/мл.
6. Жидкая композиция по п.1, отличающаяся тем, что она проявляет химическую целостность после хранения в течение 6 месяцев при температуре +25°C.
7. Жидкая композиция по п.1, отличающаяся тем, что она проявляет физическую целостность после хранения в течение 6 месяцев при температуре +25°C.
8. Жидкая композиция по п.1, отличающаяся тем, что агонист ГПП-1 выбран из группы, состоящей из ГПП-1 и его аналогов и производных, эксендина-3 и его аналогов и производных, эксендина-4 и его аналогов и производных, причем агонист ГПП-1 предпочтительно выбран из группы, состоящей из desPro36эксендин-4(1-39)-Lys6-NH2 и эксендина-4.
9. Жидкая композиция по п.1, отличающаяся тем, что она содержит следующие компоненты:
(a) desPro36эксендин-4(1-39)-Lys6-NH2,
(b) ацетат натрия,
(c) м-крезол,
(d) L-метионин,
(e) 85%-ый глицерин,
(f) соляную кислоту примерно 0,1 н, если требуется установить pH примерно 4,5,
(g) раствор NaOH примерно 0,1 н, если требуется установить pH примерно 4,5, и
(h) воду.
10. Композиция по п.1, отличающаяся тем, что она является композицией, годной для инъекций.
11. Композиция по п.1 для лечения сахарного диабета.
12. Применение композиции по любому из пп.1-11 для получения лекарственного средства для лечения сахарного диабета, более конкретно, диабета второго типа.
13. Способ получения композиции по любому из пп.1-11, включающий соединение в одной лекарственной форме агониста ГПП-1 или/и его фармакологически приемлемой соли с метионином и, необязательно, по меньшей мере одним фармакологически приемлемым эксципиентом.
14. Способ лечения пациента композицией по любому из пп.1-11, включающий введение композиции пациенту.
15. Применение композиции по одному из предыдущих пп.1-11, отличающееся тем, что оно производится вместе с введением метморфина, сульфонилмочевины, глитазона и/или инсулина/производного инсулина длительного действия, и/или их комбинации, и/или фармакологически приемлемой соли.
16. Применение по п.15, отличающееся тем, что речь идет о дополнительном лечении пациентов, у которых достаточный контроль уровня сахара в крови не может быть достигнут метморфином, сульфонилмочевиной, глитазоном и/или инсулином/производным инсулина длительного действия.
17. Применение композиции по п.15 или 16, отличающееся тем, что получающие лечение пациенты имеют показатель HbA1c в диапазоне от 7% до 10%.
18. Применение композиции по пп.15 или 16 для лечения диабета II типа и/или ожирения.
19. Применение композиции по п.17 для лечения диабета II типа и/или ожирения.
20. Применение композиции по пп.1-11 для введения пациентам с диабетом II типа как дополнение к диете, чтобы улучшить контроль уровня сахара в крови.
21. Применение композиции по пп.1-11 для введения пациенту один раз в день.
22. Применение по п.12 для введения пациенту один раз в день.
23. Способ по п.13, где композицию вводят пациенту один раз в день.
24. Способ по п.14, где композицию вводят пациенту один раз в день.
25. Применение по п.15 для введения пациенту один раз в день.
26. Применение по п.16 для введения пациенту один раз в день.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102009052832.6 | 2009-11-13 | ||
| DE102009052832 | 2009-11-13 | ||
| DE102010011919.9 | 2010-03-18 | ||
| DE102010011919A DE102010011919A1 (de) | 2010-03-18 | 2010-03-18 | Pharmazeutische Zusammensetzung umfassend einen GLP-1-Agonisten und Methionin |
| PCT/EP2010/067249 WO2011058082A1 (de) | 2009-11-13 | 2010-11-11 | Pharmazeutische zusammensetzung umfassend einen glp-1-agonisten und methionin |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2012123739A true RU2012123739A (ru) | 2013-12-20 |
| RU2573995C2 RU2573995C2 (ru) | 2016-01-27 |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2012123739/15A RU2573995C2 (ru) | 2009-11-13 | 2010-11-11 | Фармацевтическая композиция, содержащая агонист гпп-1 и метионин |
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| Country | Link |
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| US (6) | US9707176B2 (ru) |
| EP (2) | EP3345593B1 (ru) |
| JP (1) | JP5973918B2 (ru) |
| KR (3) | KR101915454B1 (ru) |
| CN (1) | CN102711804B (ru) |
| AR (1) | AR078973A1 (ru) |
| AU (1) | AU2010317994B2 (ru) |
| BR (1) | BR112012011403B8 (ru) |
| CA (1) | CA2780043C (ru) |
| CL (1) | CL2012001233A1 (ru) |
| CO (1) | CO6541566A2 (ru) |
| CR (1) | CR20120242A (ru) |
| CY (1) | CY1120270T1 (ru) |
| DK (1) | DK2498801T3 (ru) |
| DO (1) | DOP2012000132A (ru) |
| EC (1) | ECSP12011889A (ru) |
| ES (2) | ES2667069T3 (ru) |
| HR (1) | HRP20180653T1 (ru) |
| HU (1) | HUE037735T2 (ru) |
| IL (1) | IL219722B (ru) |
| LT (1) | LT2498801T (ru) |
| MA (1) | MA33735B1 (ru) |
| MX (1) | MX2012005184A (ru) |
| MY (1) | MY159565A (ru) |
| NI (1) | NI201200086A (ru) |
| NZ (1) | NZ599847A (ru) |
| PE (1) | PE20121316A1 (ru) |
| PH (1) | PH12012500888A1 (ru) |
| PL (2) | PL3345593T3 (ru) |
| PT (2) | PT3345593T (ru) |
| RU (1) | RU2573995C2 (ru) |
| SG (1) | SG10201500871TA (ru) |
| SI (1) | SI2498801T1 (ru) |
| TN (1) | TN2012000215A1 (ru) |
| TW (1) | TWI468171B (ru) |
| UY (1) | UY33025A (ru) |
| WO (1) | WO2011058082A1 (ru) |
| ZA (1) | ZA201203035B (ru) |
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| HUE048608T2 (hu) | 2008-10-17 | 2020-08-28 | Sanofi Aventis Deutschland | Egy inzulin és egy GLP-1 agonista kombinációja |
| US20120252724A1 (en) * | 2009-07-06 | 2012-10-04 | Sanofi-Aventis | Insulin preparations containing methionine |
| RU2537239C2 (ru) * | 2009-11-13 | 2014-12-27 | Санофи-Авентис Дойчланд Гмбх | Фармацевтическая композиция, включающая агонист glp-1, инсулин и метионин |
| LT2498801T (lt) | 2009-11-13 | 2018-05-10 | Sanofi-Aventis Deutschland Gmbh | Farmacinė kompozicija, apimanti despro36eksendin-4(1-39)-lys6-nh2 ir metioniną |
| AU2011202239C1 (en) | 2010-05-19 | 2017-03-16 | Sanofi | Long-acting formulations of insulins |
| HUE031181T2 (en) | 2010-08-30 | 2017-06-28 | Sanofi Aventis Deutschland | Use of AVE0010 for the manufacture of a medicament for the treatment of type 2 diabetes |
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| EP2679270B1 (en) * | 2011-02-24 | 2016-11-09 | Hisamitsu Pharmaceutical Co., Inc. | Glp-1 analogue composition for microneedle devices |
| 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 |
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