JP2013516444A - 乾燥粉末フィブリンシーラント - Google Patents
乾燥粉末フィブリンシーラント Download PDFInfo
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- JP2013516444A JP2013516444A JP2012547517A JP2012547517A JP2013516444A JP 2013516444 A JP2013516444 A JP 2013516444A JP 2012547517 A JP2012547517 A JP 2012547517A JP 2012547517 A JP2012547517 A JP 2012547517A JP 2013516444 A JP2013516444 A JP 2013516444A
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
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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
- A61K38/36—Blood coagulation or fibrinolysis factors
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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
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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
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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
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/363—Fibrinogen
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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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4833—Thrombin (3.4.21.5)
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/10—Polypeptides; Proteins
- A61L24/106—Fibrin; Fibrinogen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
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- 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
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dispersion Chemistry (AREA)
- Surgery (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Materials For Medical Uses (AREA)
Abstract
【選択図】なし
Description
実施例
実施例1
有効性試験
実施例2
実施例3
実施例4
実施例5
実施例6
止血のブタ脾臓のパンチ生検モデルの展開
ブタ脾臓パンチ生検におけるFibrocaps薬理学
ウサギ肝臓切除モデルにおけるFibrocapsの効果
ブタ肝臓パンチ生検モデルにおけるFibrocaps+ゼラチンスポンジの薬理学
ブタ肝臓外科的生検におけるFibrocaps
ヒツジPTFE血管グラフトモデルにおけるFibrocapsの予備的研究
Claims (13)
- 創傷の局所的処置における止血剤として使用するための医薬用乾燥粉末組成物であり、医薬用乾燥粉末組成物が、フィブリノーゲンを含む第一微小粒子と、トロンビンを含む第二微小粒子との混合物を含み、前記創傷が、軽症の表皮剥離、切断、掻把、擦傷、火傷、日焼け、潰瘍、内静脈出血、外静脈出血、並びに胃腸管系を含む外科的処置、実質性器官での外科的処置;耳、鼻及び喉領域(ENT)における外科的処置、心血管手術、美容外科手術、脊髄外科手術、神経外科手術;リンパ管、胆管、及び脳脊(CSF)髄瘻、胸部及び肺手術中の空気漏れ、胸部手術、整形外科手術;婦人科的手術処置;血管手術及び緊急外科手術などから選択される外科的処置から選択される、医薬用乾燥粉末組成物。
- 前記外科的処置が、整形外科手術、肝臓切除術、軟組織損傷又は手術及び血管手術から選択される、請求項1に記載の医薬用乾燥粉末組成物。
- 前記使用が、手術中又は手術後の局所投与によって特徴づけられる、請求項1又は2に記載の医薬用乾燥粉末組成物。
- 前記組成物が、乾燥接着コーティング、エアゾール、乾燥エアゾール、ポンプスプレー、医療用圧迫ガーゼ;フィルム;被覆プラスター;薬用スポンジ又は外科用パッチ止血フリース;ガーゼ;膏薬、セミゲル、ゲル、泡沫剤、ペースト、懸濁液、軟膏剤、乳化剤、成形可能剤、外科用包帯剤、創部充填、綿棒、カテーテル、光ファイバ、注射器、ペッサリー、坐薬、又は液体中又は非水性液体中の懸濁液として製剤化される、請求項1〜3のうちのいずれか一項に記載の医薬用乾燥粉末組成物。
- 前記第一微小粒子が、0.5〜20重量%のフィブリノーゲンを含有する、請求項1〜4のうちのいずれか一項に記載の医薬用乾燥粉末組成物。
- 前記第二微小粒子が、25〜1000IU/gのトロンビンを含む、請求項1〜5のうちのいずれか一項に記載の医薬用乾燥粉末組成物。
- 0.01〜95重量%の添加剤材料を更に含む、請求項1〜6のうちのいずれか一項に記載の医薬用乾燥粉末組成物。
- 前記フィビリノーゲン及び/又はトロンビンが組換体である、請求項1〜7のうちのいずれか一項に記載の医薬用乾燥粉末組成物。
- 前記組換体フィブリノーゲンが、HMW fib又はアルファ延長fibである、請求項8に記載の医薬用乾燥粉末組成物。
- 創傷を処置する方法であり、方法は、請求項1〜9のうちのいずれか一項に記載されたような医薬用乾燥粉末組成物を創傷に投与することを含む、方法。
- 前記処置が、投与後に10分以下の止血までの時間をもたらす、請求項10に記載の方法。
- 前記処置が、投与後に5分以下の止血までの時間をもたらす、請求項10に記載の方法。
- 前記処置が、投与後に3分以下の止血までの時間をもたらす、請求項10に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP10150392 | 2010-01-08 | ||
EP10150392.8 | 2010-01-08 | ||
PCT/EP2011/050192 WO2011083154A1 (en) | 2010-01-08 | 2011-01-07 | Dry powder fibrin sealant |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015213723A Division JP2016074673A (ja) | 2010-01-08 | 2015-10-30 | 乾燥粉末フィブリンシーラント |
Publications (1)
Publication Number | Publication Date |
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JP2013516444A true JP2013516444A (ja) | 2013-05-13 |
Family
ID=42035714
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012547517A Pending JP2013516444A (ja) | 2010-01-08 | 2011-01-07 | 乾燥粉末フィブリンシーラント |
JP2015213723A Pending JP2016074673A (ja) | 2010-01-08 | 2015-10-30 | 乾燥粉末フィブリンシーラント |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015213723A Pending JP2016074673A (ja) | 2010-01-08 | 2015-10-30 | 乾燥粉末フィブリンシーラント |
Country Status (12)
Country | Link |
---|---|
US (1) | US8846105B2 (ja) |
EP (1) | EP2521538B1 (ja) |
JP (2) | JP2013516444A (ja) |
KR (1) | KR20120125465A (ja) |
CN (1) | CN102724968A (ja) |
AU (1) | AU2011204558B2 (ja) |
BR (1) | BR112012016633A2 (ja) |
CA (1) | CA2785595C (ja) |
IL (1) | IL220832A (ja) |
MX (1) | MX2012007922A (ja) |
NZ (1) | NZ600812A (ja) |
WO (1) | WO2011083154A1 (ja) |
Families Citing this family (36)
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US9827205B2 (en) * | 2008-12-12 | 2017-11-28 | Mallinckrodt Pharma Ip Trading D.A.C. | Dry powder fibrin sealant |
US20110237994A1 (en) * | 2010-03-25 | 2011-09-29 | Combat Medical Systems, Llc | Void-filling wound dressing |
JP5973997B2 (ja) * | 2010-06-01 | 2016-08-23 | バクスター・インターナショナル・インコーポレイテッドBaxter International Incorp0Rated | 乾燥した安定な止血用組成物を作製するためのプロセス |
EP2822474B1 (en) | 2012-03-06 | 2018-05-02 | Ferrosan Medical Devices A/S | Pressurized container containing haemostatic paste |
BR112014030962A2 (pt) | 2012-06-12 | 2017-06-27 | Ferrosan Medical Devices As | métodos para preparação e para reconstituição de uma composição seca adequada para uso em hemostase e cicatrização de feridas, e, kit hemostático |
AU2013353931B2 (en) * | 2012-12-07 | 2016-12-08 | Baxter Healthcare S.A. | Hemostatic foam |
KR101401944B1 (ko) * | 2012-12-11 | 2014-05-30 | 세원셀론텍(주) | 콜라겐과 피브린이 혼합된 조직 실란트 및 그 제조방법 |
DK2950822T3 (da) * | 2013-01-30 | 2019-07-22 | Daewoong Co Ltd | Farmaceutisk sammensætning til beskyttelse af sår, tilvejebringelse af hæmostase eller forebyggelse af adhæsion i mave-tarm-kanalen |
BR112015017463A8 (pt) * | 2013-03-07 | 2017-11-28 | Profibrix Bv | Formulação em pó |
US9724078B2 (en) | 2013-06-21 | 2017-08-08 | Ferrosan Medical Devices A/S | Vacuum expanded dry composition and syringe for retaining same |
EP3013294B1 (en) | 2013-06-28 | 2019-09-25 | 3M Innovative Properties Company | Fibrin-coated wound dressing |
US10765774B2 (en) | 2013-07-09 | 2020-09-08 | Ethicon, Inc. | Hemostatic pad assembly kit and method |
EP3656388A1 (en) * | 2013-11-25 | 2020-05-27 | D.T.R. Dermal Therapy Research Inc. | Composition, system and method for treating skin |
IL229645A0 (en) * | 2013-11-26 | 2014-03-31 | Omrix Biopharmaceuticals Ltd | A dry bandage containing thrombin and pectin |
EP3470094B1 (en) | 2013-12-11 | 2020-07-22 | Ferrosan Medical Devices A/S | Dry composition comprising an extrusion enhancer |
CA2937049C (en) * | 2013-12-16 | 2024-01-16 | The University Of British Columbia | Self-fueled particles for propulsion through flowing aqueous fluids |
WO2016058612A1 (en) | 2014-10-13 | 2016-04-21 | Ferrosan Medical Devices A/S | Dry composition for use in haemostasis and wound healing |
WO2016102446A1 (en) | 2014-12-24 | 2016-06-30 | Ferrosan Medical Devices A/S | Syringe for retaining and mixing first and second substances |
WO2017005590A1 (en) | 2015-07-03 | 2017-01-12 | Ferrosan Medical Devices A/S | Syringe for mixing two components and for retaining a vacuum in a storage condition |
US10501715B1 (en) | 2015-09-11 | 2019-12-10 | Mark H. Widick | System for the formation of fibrin foam |
US10159720B2 (en) | 2015-12-08 | 2018-12-25 | Omrix Biopharmaceuticals Ltd | Thrombin microcapsules, preparation and uses thereof |
IL242984A0 (en) | 2015-12-08 | 2016-02-29 | Omrix Biopharmaceuticals Ltd | Thrombin microcapsules, their preparation and how to use them |
CN108348633B (zh) | 2015-11-06 | 2022-07-08 | 伊西康公司 | 压实止血纤维素聚集体 |
CN107754005B (zh) | 2016-08-15 | 2021-06-15 | 广州倍绣生物技术有限公司 | 止血组合物及其制造方法 |
US11413335B2 (en) | 2018-02-13 | 2022-08-16 | Guangzhou Bioseal Biotech Co. Ltd | Hemostatic compositions and methods of making thereof |
TR201714879A2 (tr) * | 2017-10-03 | 2019-04-22 | Montero Gida Sanayi Ve Ticaret Anonim Sirketi | Hemostati̇k kompozi̇syonlar |
EP4321182A2 (en) | 2018-05-09 | 2024-02-14 | Ferrosan Medical Devices A/S | Method for preparing a haemostatic composition |
EP3895890A4 (en) * | 2018-12-14 | 2022-08-31 | Bmg Incorporated | SHEET-FORM, TISSUE-ADHESIVE REINFORCEMENT MATERIAL WITH DUAL REAGENTS |
CN111035799A (zh) * | 2019-01-02 | 2020-04-21 | 浙江西安交通大学研究院 | 用于获得自推式发泡组织密封胶的自推进颗粒及其制备方法 |
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KR20210052099A (ko) * | 2019-10-31 | 2021-05-10 | 주식회사 삼양바이오팜 | 분말형 지혈제 조성물 및 이의 제조 방법 |
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CN112972755B (zh) * | 2021-03-25 | 2022-07-05 | 哈尔滨瀚邦医疗科技有限公司 | 一种基于猪源纤维蛋白原和凝血酶的生物止血材料的制备方法 |
WO2023115427A1 (en) | 2021-12-23 | 2023-06-29 | Guangzhou Bioseal Biotech Co., Ltd. | Spray dried thrombin |
KR102442102B1 (ko) * | 2022-02-15 | 2022-09-08 | (주)시지바이오 | 위장관 내 지혈 및 상처 치료용 약학 조성물 |
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- 2011-01-07 WO PCT/EP2011/050192 patent/WO2011083154A1/en active Application Filing
- 2011-01-07 CA CA2785595A patent/CA2785595C/en not_active Expired - Fee Related
- 2011-01-07 NZ NZ600812A patent/NZ600812A/en not_active IP Right Cessation
- 2011-01-07 MX MX2012007922A patent/MX2012007922A/es active IP Right Grant
- 2011-01-07 EP EP11700053.9A patent/EP2521538B1/en not_active Not-in-force
- 2011-01-07 AU AU2011204558A patent/AU2011204558B2/en not_active Ceased
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KR20120125465A (ko) | 2012-11-15 |
US8846105B2 (en) | 2014-09-30 |
EP2521538A1 (en) | 2012-11-14 |
WO2011083154A1 (en) | 2011-07-14 |
IL220832A (en) | 2015-09-24 |
CA2785595C (en) | 2018-08-14 |
BR112012016633A2 (pt) | 2016-04-19 |
US20120315305A1 (en) | 2012-12-13 |
EP2521538B1 (en) | 2018-10-24 |
AU2011204558B2 (en) | 2015-01-22 |
NZ600812A (en) | 2014-08-29 |
AU2011204558A1 (en) | 2012-07-19 |
JP2016074673A (ja) | 2016-05-12 |
MX2012007922A (es) | 2012-08-03 |
CN102724968A (zh) | 2012-10-10 |
CA2785595A1 (en) | 2011-07-14 |
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