HRP20191464T1 - Hemostatski pripravci - Google Patents

Hemostatski pripravci Download PDF

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Publication number
HRP20191464T1
HRP20191464T1 HRP20191464T HRP20191464T1 HR P20191464 T1 HRP20191464 T1 HR P20191464T1 HR P20191464 T HRP20191464 T HR P20191464T HR P20191464 T1 HRP20191464 T1 HR P20191464T1
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HR
Croatia
Prior art keywords
preparation
mass
collagen
relative
total mass
Prior art date
Application number
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English (en)
Inventor
Christian Gagnieu
Patricia Forest
Sylvain Picot
Original Assignee
Biomup
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.)
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Publication date
Priority claimed from EP12717682.4A external-priority patent/EP2701729B1/en
Application filed by Biomup filed Critical Biomup
Publication of HRP20191464T1 publication Critical patent/HRP20191464T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001Use of materials characterised by their function or physical properties
    • A61L24/0015Medicaments; Biocides
    • 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
    • A61L24/00Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/043Mixtures of macromolecular materials
    • 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
    • A61L26/0028Polypeptides; Proteins; Degradation products thereof
    • A61L26/0033Collagen
    • 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
    • A61L2300/23Carbohydrates
    • A61L2300/232Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Surgery (AREA)
  • Materials Engineering (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (16)

1. Hemostatski pripravak u obliku praška koji sadrži: - kolagen fibrilarnog tipa u kojem je maseni udio fibroznog kolagena i/ili fibrilarnog kolagena najmanje 70% relativno prema ukupnoj masi kolagena, maseni udio rečenog kolagena je u rasponu od 75% do 96% relativno prema ukupnoj masi pripravka, - najmanje jedan monosaharid čiji je maseni udio u rasponu od 1% do 12.5% relativno prema ukupnoj masi pripravka, te - najmanje jedan glikozaminoglikan čiji je maseni udio u rasponu od 2% do 25% relativno prema ukupnoj masi pripravka.
2. Pripravak iz patentnog zahtjeva 1, naznačeno time da rečeni pripravak sadrži kolagen/monosaharid masenog omjera u rasponu od 10 do 50, i preferirano 19.
3. Pripravak iz bilo kojeg od patentnih zahtjeva 1 do 2, naznačeno time da kolagen sadrži maseni udio fibroznog kolagena i/ili fibrilarnog kolagena u rasponu od 85% do 95% relativno prema ukupnoj masi kolagena.
4. Pripravak iz bilo kojeg od patentnih zahtjeva 1 do 3, naznačeno time da rečeni pripravak dalje ima maseni omjer kolagena/ukupnih spojeva ugljikohidrata u rasponu od 2 do 40, pri čemu je masa ukupnih spojeva ugljikohidrata zbroj mase monosaharida i mase glikozaminoglikana.
5. Pripravak iz bilo kojeg od patentnih zahtjeva 1 do 4, naznačeno time da rečeni pripravak dalje sadrži koagulacijski faktor, posebno trombin, u količini u rasponu od 0.01 IU/mg do 20 IU/mg pripravka.
6. Pripravak iz bilo kojeg od patentnih zahtjeva 1 do 5, naznačeno time da rečeni pripravak ima gustoću nakon potresanja veću od 0.4 g/mL.
7. Pripravak iz bilo kojeg od patentnih zahtjeva 1 do 6, naznačeno time da rečeni pripravak sadrži barem 50% po masi čestica veličine između 200 µm i 400 µm.
8. Pripravak iz bilo kojeg od patentnih zahtjeva 1 do 7, naznačeno time da je glikozaminoglikan odabran između hondroitin-sulfata, dermatan-sulfata, hijaluronske kiseline i njihove smjese.
9. Pripravak iz bilo kojeg od patentnih zahtjeva 1 do 8, naznačeno time da je - kolagen u rasponu masenog udjela od 80% do 90% relativno prema ukupnoj masi pripravka, - najmanje jedan monosaharid u rasponu masenog udjela od 2.5% do 7.5% relativno prema ukupnoj masi pripravka, te - najmanje jedan glikozaminoglikan u rasponu masenog udjela od 5% do 12.5% relativno prema ukupnoj masi pripravka.
10. Pripravak iz bilo kojeg od patentnih zahtjeva 1 do 8, koji sadrži: - kolagen u količini od 86.36% po masi relativno prema ukupnoj masi pripravka, - glukozu u količini od 4.54% po masi relativno prema ukupnoj masi pripravka, - hondroitin-sulfat u količini od 9.09% po masi relativno prema ukupnoj masi pripravka.
11. Pripravak iz bilo kojeg od patentnih zahtjeva 9 ili 10, koji dalje sadrži trombin u količini od 0.2 IU/mg do 2 IU/mg pripravka.
12. Metoda priprave hemostatskog pripravka koja obuhvaća barem sljedeće korake: a) tvorba vodene suspenzije koja sadrži kolagen fibrilarnog tipa koji ima maseni udio fibroznog kolagena i/ili fibrilarnog kolagena najmanje 70% relativno prema ukupnoj masi kolagena, i najmanje jedan monosaharid, s masenim udjelom kolagena u rasponu od 75% do 96% relativno prema ukupnoj masi pripravka i maseni udio monosaharida u rasponu od 1% do 12.5% relativno prema ukupnoj masi pripravka, b) izolacija produkta u obliku taloga, paste ili gela, posebno centrifugiranjem ili dekantiranjem, c) sušenje produkta, d) mljevenje produkta do željene granulometrije, e) dodavanje najmanje jednog glikozaminoglikana masenog udjela u rasponu od 2% do 25% relativno prema ukupnoj masi pripravka.
13. Metoda iz patentnog zahtjeva 12, naznačeno time da je kolagen korišten u koraku a) dobiven baznom ekstrakcijom.
14. Metoda iz bilo kojeg od patentnih zahtjeva 12 ili 13, naznačeno time da je u koraku e) dalje dodan najmanje jedan koagulacijski faktor, posebno trombin.
15. Pripravak kako je definiran u bilo kojem od patentnih zahtjeva 1 do 11 ili kako je dobiven metodom definiranoj u patentnom zahtjevu 12 za upotrebu istoga kao hemostatsko sredstvo.
16. Paket koji sadrži: - pripravak iz bilo kojeg od patentnih zahtjeva 1 do 11, te - uređaj za raspršivanje.
HRP20191464 2011-04-27 2019-08-14 Hemostatski pripravci HRP20191464T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201161517973P 2011-04-27 2011-04-27
EP11305492 2011-04-27
EP12717682.4A EP2701729B1 (en) 2011-04-27 2012-04-26 Hemostatic compositions
PCT/EP2012/057647 WO2012146655A1 (en) 2011-04-27 2012-04-26 Hemostatic compositions

Publications (1)

Publication Number Publication Date
HRP20191464T1 true HRP20191464T1 (hr) 2019-11-15

Family

ID=67477786

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20191464 HRP20191464T1 (hr) 2011-04-27 2019-08-14 Hemostatski pripravci

Country Status (6)

Country Link
DK (1) DK2701729T3 (hr)
ES (1) ES2742269T3 (hr)
HR (1) HRP20191464T1 (hr)
HU (2) HUE044687T2 (hr)
LT (1) LT2701729T (hr)
PT (2) PT2701729T (hr)

Also Published As

Publication number Publication date
HUE044687T2 (hu) 2019-11-28
PT2701729T (pt) 2019-09-10
ES2742269T3 (es) 2020-02-13
DK2701729T3 (da) 2019-08-05
PT3513803T (pt) 2021-08-10
LT2701729T (lt) 2019-08-12
HUE055372T2 (hu) 2021-11-29

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