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RU2006131128A - Гемостатические спреи и композиции - Google Patents

Гемостатические спреи и композиции Download PDF

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RU2006131128A
RU2006131128A RU2006131128/15A RU2006131128A RU2006131128A RU 2006131128 A RU2006131128 A RU 2006131128A RU 2006131128/15 A RU2006131128/15 A RU 2006131128/15A RU 2006131128 A RU2006131128 A RU 2006131128A RU 2006131128 A RU2006131128 A RU 2006131128A
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composition
delivery system
powder
specified
gelatin
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RU2006131128/15A
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RU2377022C9 (ru
RU2377022C2 (ru
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Лене МЕЛЛЕР (DK)
Лене МЕЛЛЕР
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Ферросан А/С (Dk)
Ферросан А/С
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06Ampoules or carpules
    • A61J1/067Flexible ampoules, the contents of which are expelled by squeezing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/363Fibrinogen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/45Transferases (2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4833Thrombin (3.4.21.5)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/55Protease inhibitors
    • A61K38/57Protease inhibitors from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • A61L15/325Collagen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00Rigid or semi-rigid containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material or by deep-drawing operations performed on sheet material
    • B65D1/32Containers adapted to be temporarily deformed by external pressure to expel contents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00Containers or packages with special means for dispensing contents
    • B65D83/06Containers or packages with special means for dispensing contents for dispensing powdered or granular material

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Zoology (AREA)
  • Mechanical Engineering (AREA)
  • Ceramic Engineering (AREA)
  • Biomedical Technology (AREA)
  • Materials Engineering (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (48)

1. Система доставки порошка, включающая камеру для хранения композиции, содержащей желатиновый или коллагеновый порошок, имеющий средний размер частиц, по меньшей мере, 10 мкм, при этом указанная камера имеет, по меньшей мере, одно выпускное отверстие, имеющее такой размер, чтобы обеспечить высвобождение указанной композиции.
2. Система доставки по п.1, в которой указанное выпускное отверстие откалибровано таким образом, чтобы обеспечить высвобождение указанной композиции с ее распределением по поверхности в контролируемых количествах.
3. Система доставки по п.1, дополнительно содержащая удлиненный носик для обеспечения высвобождения композиции.
4. Система доставки по п.1, где система доставки приводится в действие вручную.
5. Система доставки по п.4, где система доставки приводится в действие вручную посредством встряхивания или сжатия системы.
6. Система доставки по п.1, в которой система доставки содержит упругоэластичную камеру или сильфон.
7. Система доставки по п.6, в которой упругоэластичная камера или сильфон приспособлены к тому, чтобы приводиться в действие вручную, например, посредством пальцевого надавливания, для того, чтобы высвободить, по меньшей мере, часть композиции.
8. Система доставки по п.1, дополнительно содержащая защитную конструкцию, расположенную в области выпускного отверстия.
9. Система доставки по п.8, в которой защитная конструкция представляет собой часть, являющуюся краевым ограждением, выполненную с возможностью выдаваться вперед по отношению к выпускному отверстию.
10. Система доставки по п.1, в которой указанная композиция содержит желатин.
11. Система доставки по п.1, в которой указанная композиция содержит коллаген.
12. Система доставки по п.1, в которой указанная композиция содержит смесь желатина и коллагена.
13. Система доставки по п.1, в которой указанный порошок имеет средний размер частиц в диапазоне от 20 до 250 мкм.
14. Система доставки по п.1, в которой порошок имеет распределение частиц по размерам, в соответствии с которыми, по меньшей мере, 80% по объему частиц имеют размер частиц, составляющий 15-170 мкм.
15. Система доставки по п.1, в которой указанный порошок является сухим порошком.
16. Система доставки по п.15, в которой содержание влаги в порошке составляет, по большей мере, 20 мас.%, предпочтительно, по большей мере 15 мас.%.
17. Система доставки по п.1, в которой указанный порошок имеет насыпную плотность в диапазоне от 0,05 до 0,3 г/мл.
18. Система доставки по п.1, в которой указанная композиция дополнительно содержит средство, которое улучшает адгезионные свойства указанной композиции.
19. Система доставки по п.18, в которой указанное средство выбрано из группы, состоящей из сахарозы, глюкозы и их комбинаций.
20. Система доставки по п.18, в которой указанное средство смешано с указанным порошком.
21. Система доставки по п.18, в которой указанное средство нанесено на поверхность указанного порошка.
22. Система доставки по п.19, в которой указанная композиция содержит 0,1-50 мас.% указанного средства из расчета на общую массу композиции.
23. Система доставки по п.1, в которой указанная композиция дополнительно содержит фактор свертывания.
24. Система доставки по п.23, в которой указанный фактор свертывания выбран из группы, состоящей из тромбина, фибриногена, апротинина, фибронектина, фактора XIII, фактора VII, фактора VIII и их комбинаций.
25. Система доставки по п.1, в которой указанная композиция не содержит фактора свертывания.
26. Система доставки по п.1, в которой указанная система доставки не содержит никаких пропеллентов.
27. Система доставки порошка, содержащая камеру для хранения композиции, состоящей из желатинового или коллагенового порошка, имеющего средний размер частиц, по меньшей мере, 10 мкм, при этом указанная камера имеет, по меньшей мере, одно выпускное отверстие, имеющее такой размер, чтобы обеспечить высвобождение указанной композиции.
28. Система доставки по п.27, где указанная система доставки является системой, определенной в любом из пп.2-9.
29. Система доставки по п.27 или 28, в которой указанный порошок является порошком, определенным в любом из пп.13-17.
30. Применение композиции, определенной в любом из предшествующих пунктов, в качестве лекарственного средства для осуществления гемостаза.
31. Способ осуществления гемостаза у пациента, нуждающегося в его осуществлении, включающий аэрозольное нанесение композиции, определенной в любом из пп.1-29, на, по меньшей мере, часть области, где происходит кровотечение.
32. Применение желатинового или коллагенового порошка, имеющего средний размер частиц, по меньшей мере, 10 мкм, для изготовления композиции, определенной в любом из пп.1-29, для осуществления гемостаза, где указанную композицию аэрозольно наносят на, по меньшей мере, часть области, где происходит кровотечение.
33. Система доставки порошка, содержащая камеру для хранения порошковой композиции, при этом указанная камера содержит, по меньшей мере, одно выпускное отверстие, имеющее такой размер, чтобы обеспечить высвобождение указанной композиции, и защитную конструкцию, расположенную в области выпускного отверстия.
34. Система доставки по п.33, где указанная система доставки является системой, определенной в любом из пп.2-7.
35. Система доставки по п.34, в которой защитная конструкция представляет собой часть, являющуюся краевым ограждением, выполненную с возможностью выступать вперед по отношению к выпускному отверстию.
36. Композиция для осуществления гемостаза, содержащая частицы желатина или коллагена, имеющие средний размер частиц, по меньшей мере, 10 мкм, где указанная композиция находится в виде геля.
37. Композиция по п.36, где указанная композиция содержит 1-20 мл жидкой среды на один грамм желатина или один грамм коллагена.
38. Композиция по п.37, где указанная композиция содержит 8-12 мл жидкой среды на один грамм желатина или один грамм коллагена.
39. Композиция по п.37, в которой указанная жидкая среда является водной средой.
40. Композиция по п.39, в которой указанная водная среда содержит растворенный в ней хлористый натрий.
41. Композиция по п.40, в которой указанная водная среда является солевым раствором.
42. Композиция по п.36, где указанная композиция содержит частицы желатина.
43. Композиция по п.36, в которой указанная композиция содержит частицы коллагена.
44. Композиция по п.36, в которой указанная композиция содержит смесь частиц коллагена и желатина.
45. Композиция по п.36, в которой указанные частицы являются частицами, определенными в любом из пп.13-17.
46. Композиция по любому из пп.36-45 для применения в качестве лекарственного средства.
47. Применение композиции, определенной в любом из пп.36-45, для производства лекарственного средства для осуществления гемостаза.
48. Способ осуществления гемостаза у пациента, нуждающегося в его осуществлении, включающий нанесение композиции, определенной в любом из пп.36-45, на, по меньшей мере, часть области, в которой происходит кровотечение.
RU2006131128/15A 2004-01-30 2005-01-28 Гемостатические спреи и композиции RU2377022C9 (ru)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US54000504P 2004-01-30 2004-01-30
US60/540,005 2004-01-30
US54697204P 2004-02-24 2004-02-24
US60/546,972 2004-02-24

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RU2006131128A true RU2006131128A (ru) 2008-03-10
RU2377022C2 RU2377022C2 (ru) 2009-12-27
RU2377022C9 RU2377022C9 (ru) 2010-08-10

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US (1) US7923031B2 (ru)
EP (1) EP1713521B1 (ru)
JP (1) JP2007519450A (ru)
CN (1) CN1921896B (ru)
AR (1) AR054637A1 (ru)
AT (1) ATE475434T1 (ru)
CA (1) CA2554994C (ru)
DE (1) DE602005022554D1 (ru)
RU (1) RU2377022C9 (ru)
WO (1) WO2005072700A2 (ru)

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US20070160543A1 (en) 2007-07-12
DE602005022554D1 (de) 2010-09-09
CA2554994A1 (en) 2005-08-11
ATE475434T1 (de) 2010-08-15
WO2005072700A3 (en) 2005-09-09
CA2554994C (en) 2015-05-19
CN1921896B (zh) 2010-11-24
JP2007519450A (ja) 2007-07-19
EP1713521A2 (en) 2006-10-25
US7923031B2 (en) 2011-04-12
WO2005072700A2 (en) 2005-08-11
RU2377022C2 (ru) 2009-12-27
AR054637A1 (es) 2007-07-11

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