BR112015017463A2 - formulação em pó - Google Patents

formulação em pó

Info

Publication number
BR112015017463A2
BR112015017463A2 BR112015017463A BR112015017463A BR112015017463A2 BR 112015017463 A2 BR112015017463 A2 BR 112015017463A2 BR 112015017463 A BR112015017463 A BR 112015017463A BR 112015017463 A BR112015017463 A BR 112015017463A BR 112015017463 A2 BR112015017463 A2 BR 112015017463A2
Authority
BR
Brazil
Prior art keywords
raw material
powder
liquid
thrombin
solution
Prior art date
Application number
BR112015017463A
Other languages
English (en)
Other versions
BR112015017463A8 (pt
Inventor
Martyn Glen
Adrianus Hendricus Van Pinxteren Laurens
Kim Whitfield Nicola
Original Assignee
Profibrix Bv
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GBGB1304145.4A external-priority patent/GB201304145D0/en
Priority claimed from GBGB1304146.2A external-priority patent/GB201304146D0/en
Priority claimed from GBGB1313909.2A external-priority patent/GB201313909D0/en
Application filed by Profibrix Bv filed Critical Profibrix Bv
Publication of BR112015017463A2 publication Critical patent/BR112015017463A2/pt
Publication of BR112015017463A8 publication Critical patent/BR112015017463A8/pt

Links

Classifications

    • 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
    • A61K38/17Peptides 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0052Mixtures of macromolecular compounds
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/75Fibrinogen
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/6429Thrombin (3.4.21.5)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21005Thrombin (3.4.21.5)
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A61L2300/254Enzymes, proenzymes
    • 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/04Materials for stopping bleeding

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Toxicology (AREA)
  • Materials Engineering (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Materials For Medical Uses (AREA)

Abstract

resumo patente de invenção para: "formulação em pó". a presente invenção refere-se a composições em pó estéreis adequadas para uso médico que compreendem trombina e fibrinogênio, e a métodos para produzir as mesmas, em que o pó de trombina é produzido a partir de uma matéria-prima líquida, em que a matéria-prima compreende uma solução ou uma suspensão de trombina, de preferência, uma solução, em que o pó é produzido pela remoção de líquido por um processo selecionado a partir de secagem por aspersão asséptica ou secagem em leito fluidizado asséptica, e em que o pó resultante da remoção de líquido da matéria-prima exibe pelo menos 80% da potência ou atividade de trombina da matéria-prima líquida, e em que o pó de fibrinogênio é produzido pela remoção de líquido de uma matéria-prima, em que a matéria-prima compreende uma solução ou uma suspensão de fibrinogênio, de preferência, uma solução, por secagem por aspersão asséptica ou secagem em leito fluidizado asséptica, e em que a dita composição é embalada como um produto farmacêutico final estéril para uso médico.
BR112015017463A 2013-03-07 2014-03-07 Formulação em pó BR112015017463A8 (pt)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201361774143P 2013-03-07 2013-03-07
US201361774125P 2013-03-07 2013-03-07
GBGB1304145.4A GB201304145D0 (en) 2013-03-07 2013-03-07 Powder formulation
GBGB1304146.2A GB201304146D0 (en) 2013-03-07 2013-03-07 Powder formulation
GBGB1313909.2A GB201313909D0 (en) 2013-08-02 2013-08-02 Powder formulation
PCT/EP2014/054477 WO2014135689A2 (en) 2013-03-07 2014-03-07 Powder formulation

Publications (2)

Publication Number Publication Date
BR112015017463A2 true BR112015017463A2 (pt) 2017-07-11
BR112015017463A8 BR112015017463A8 (pt) 2017-11-28

Family

ID=51492058

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015017463A BR112015017463A8 (pt) 2013-03-07 2014-03-07 Formulação em pó

Country Status (11)

Country Link
US (2) US20160015792A1 (pt)
EP (1) EP2964252A2 (pt)
JP (1) JP2016510059A (pt)
CN (1) CN105188740A (pt)
AU (1) AU2014224594B2 (pt)
BR (1) BR112015017463A8 (pt)
CA (1) CA2898922A1 (pt)
EA (1) EA201591657A1 (pt)
IL (1) IL240902A0 (pt)
MX (1) MX2015011623A (pt)
WO (1) WO2014135689A2 (pt)

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IL242984A0 (en) 2015-12-08 2016-02-29 Omrix Biopharmaceuticals Ltd Thrombin microcapsules, their preparation and how to use them
US10159720B2 (en) 2015-12-08 2018-12-25 Omrix Biopharmaceuticals Ltd Thrombin microcapsules, preparation and uses thereof
JP6926101B2 (ja) 2015-11-06 2021-08-25 エシコン・インコーポレイテッドEthicon, Inc. 圧密止血セルロース系凝集体
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
US20220111020A1 (en) * 2016-08-15 2022-04-14 Guangzhou Bioseal Biotech Co. Ltd. Hemostatic compositions and methods of making thereof
US11318224B2 (en) 2016-09-28 2022-05-03 Board Of Regents Of The University Of Nebraska Nanofiber structures and methods of use thereof
US11504341B2 (en) * 2016-10-27 2022-11-22 Egy-Nano Pharma, Lp Nanotechnology-based hemostatic dressings
BR102017008027B1 (pt) * 2017-04-18 2022-04-19 Cristália Produtos Químicos Farmacêuticos Ltda Processo de obtenção de biopolímero de fibrina, meios de aplicação do referido biopolímero de fibrina, e processo de aplicação do referido biopolímero de fibrina
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JP2022554153A (ja) * 2019-10-23 2022-12-28 フィブリアント・ベスローテン・フェンノートシャップ 抗微生物剤および抗微生物治療用アジュバントとしてのフィブリノゲン
CN110947349B (zh) * 2019-12-24 2024-03-15 上海天晓环保工程有限公司 一种用于脱硫废水零排放的微波晶振干燥装置
US11795189B2 (en) * 2020-09-21 2023-10-24 University Of Kentucky Research Foundation Formulation and method for spray-drying D-tagatose
CN111956788A (zh) * 2020-09-22 2020-11-20 上海利康瑞生物工程有限公司 一种猪源纤维蛋白原冻干制剂、制备工艺及其应用
EP4217418A2 (de) * 2020-09-24 2023-08-02 Sphera Technology GmbH Mehrkomponentensystem
CN112843326B (zh) * 2021-01-26 2022-11-01 上海利康瑞生物工程有限公司 一种纤维蛋白粘合剂速效止血复合粉及其制备方法
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
WO2023017153A1 (en) * 2021-08-13 2023-02-16 Biotest Ag Fibrinogen compositions and methods of preparation
CN113797325B (zh) * 2021-09-29 2023-11-21 复旦大学 一种基于气流粉碎技术制备止血材料的方法
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Also Published As

Publication number Publication date
EA201591657A1 (ru) 2015-12-30
WO2014135689A2 (en) 2014-09-12
BR112015017463A8 (pt) 2017-11-28
US20160015792A1 (en) 2016-01-21
JP2016510059A (ja) 2016-04-04
AU2014224594A1 (en) 2015-07-02
CN105188740A (zh) 2015-12-23
MX2015011623A (es) 2015-12-17
US20190269764A1 (en) 2019-09-05
WO2014135689A3 (en) 2014-10-30
EP2964252A2 (en) 2016-01-13
AU2014224594B2 (en) 2018-05-10
IL240902A0 (en) 2015-10-29
CA2898922A1 (en) 2014-09-12

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