HRP20191464T1 - Hemostatski pripravci - Google Patents
Hemostatski pripravci Download PDFInfo
- 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
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- mass
- collagen
- relative
- total mass
- Prior art date
Links
- 230000002439 hemostatic effect Effects 0.000 title claims 3
- 239000000203 mixture Substances 0.000 title claims 2
- 238000002360 preparation method Methods 0.000 claims 33
- 102000008186 Collagen Human genes 0.000 claims 16
- 108010035532 Collagen Proteins 0.000 claims 16
- 229920001436 collagen Polymers 0.000 claims 16
- 150000002772 monosaccharides Chemical class 0.000 claims 6
- 229920002683 Glycosaminoglycan Polymers 0.000 claims 5
- 238000000034 method Methods 0.000 claims 4
- 108090000190 Thrombin Proteins 0.000 claims 3
- 102000013373 fibrillar collagen Human genes 0.000 claims 3
- 108060002894 fibrillar collagen Proteins 0.000 claims 3
- 239000000047 product Substances 0.000 claims 3
- 229960004072 thrombin Drugs 0.000 claims 3
- 108010039209 Blood Coagulation Factors Proteins 0.000 claims 2
- 102000015081 Blood Coagulation Factors Human genes 0.000 claims 2
- 229920001287 Chondroitin sulfate Polymers 0.000 claims 2
- 239000003114 blood coagulation factor Substances 0.000 claims 2
- -1 carbohydrate compounds Chemical class 0.000 claims 2
- 229940059329 chondroitin sulfate Drugs 0.000 claims 2
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims 1
- SQDAZGGFXASXDW-UHFFFAOYSA-N 5-bromo-2-(trifluoromethoxy)pyridine Chemical compound FC(F)(F)OC1=CC=C(Br)C=N1 SQDAZGGFXASXDW-UHFFFAOYSA-N 0.000 claims 1
- 229920000045 Dermatan sulfate Polymers 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- 229940030225 antihemorrhagics Drugs 0.000 claims 1
- 239000007900 aqueous suspension Substances 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 238000005119 centrifugation Methods 0.000 claims 1
- 238000010908 decantation Methods 0.000 claims 1
- AVJBPWGFOQAPRH-FWMKGIEWSA-L dermatan sulfate Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@H](OS([O-])(=O)=O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](C([O-])=O)O1 AVJBPWGFOQAPRH-FWMKGIEWSA-L 0.000 claims 1
- 229940051593 dermatan sulfate Drugs 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 238000000605 extraction Methods 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 238000001033 granulometry Methods 0.000 claims 1
- 238000000227 grinding Methods 0.000 claims 1
- 239000002874 hemostatic agent Substances 0.000 claims 1
- 229920002674 hyaluronan Polymers 0.000 claims 1
- 229960003160 hyaluronic acid Drugs 0.000 claims 1
- 238000002955 isolation Methods 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 239000002244 precipitate Substances 0.000 claims 1
- 238000005507 spraying Methods 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
-
- 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)
-
- 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
-
- 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
- A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
-
- 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
- A61L24/001—Use of materials characterised by their function or physical properties
- A61L24/0015—Medicaments; Biocides
-
- 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
- A61L24/043—Mixtures of macromolecular materials
-
- 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
- A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
- A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
- A61L26/0028—Polypeptides; Proteins; Degradation products thereof
- A61L26/0033—Collagen
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21005—Thrombin (3.4.21.5)
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/23—Carbohydrates
- A61L2300/232—Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
- A61L2300/254—Enzymes, proenzymes
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
-
- 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
Landscapes
- 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.
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) |
-
2012
- 2012-04-26 HU HUE12717682 patent/HUE044687T2/hu unknown
- 2012-04-26 PT PT12717682T patent/PT2701729T/pt unknown
- 2012-04-26 PT PT191620541T patent/PT3513803T/pt unknown
- 2012-04-26 DK DK12717682.4T patent/DK2701729T3/da active
- 2012-04-26 HU HUE19162054A patent/HUE055372T2/hu unknown
- 2012-04-26 ES ES12717682T patent/ES2742269T3/es active Active
- 2012-04-26 LT LTEP12717682.4T patent/LT2701729T/lt unknown
-
2019
- 2019-08-14 HR HRP20191464 patent/HRP20191464T1/hr unknown
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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