HRP20240065T1 - Hemostatički pripravci - Google Patents

Hemostatički pripravci Download PDF

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HRP20240065T1
HRP20240065T1 HRP20240065TT HRP20240065T HRP20240065T1 HR P20240065 T1 HRP20240065 T1 HR P20240065T1 HR P20240065T T HRP20240065T T HR P20240065TT HR P20240065 T HRP20240065 T HR P20240065T HR P20240065 T1 HRP20240065 T1 HR P20240065T1
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fibrinogen
amino acid
acid residues
optionally
binding
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HRP20240065TT
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Renata ZBOZIEN
Ben Nichols
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Haemostatix Limited
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    • 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
    • A61L26/0023Polysaccharides
    • 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
    • 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
    • A61K31/728Hyaluronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • 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
    • 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023Heat
    • 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
    • A61L24/08Polysaccharides
    • 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
    • A61L26/0047Specific proteins or polypeptides not covered by groups A61L26/0033 - A61L26/0042
    • 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
    • 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
    • A61L26/0061Use of materials characterised by their function or physical properties
    • 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
    • A61L26/0061Use of materials characterised by their function or physical properties
    • A61L26/0066Medicaments; Biocides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • 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

Claims (15)

1. Sterilni, tekući hemostatski pripravak spreman za uporabu, koji sadrži: topljivo hemostatsko sredstvo koje sadrži mnoštvo nosača i mnoštvo peptida koji vežu fibrinogen imobiliziranih na svaki nosač, pri čemu svaki nosač hemostatskog sredstva sadrži razgranatu jezgru na koju su peptidi koji vežu fibrinogen odvojeno kovalentno vezani; biokompatibilnu tekućinu; i čestice biokompatibilnog umreženog polisaharida pogodnog za uporabu u hemostazi i koje su netopljive u biokompatibilnoj tekućini; pri čemu razgranata jezgra sadrži: od dva do deset multifunkcionalnih aminokiselinskih ostataka, pri čemu je svaki peptid koji veže fibrinogen odvojeno kovalentno vezan na multifunkcionalni aminokiselinski ostatak razgranate jezgre; mnoštvo višenamjenskih aminokiselinskih ostataka, pri čemu su jedan ili više peptida koji vežu fibrinogen odvojeno kovalentno vezani za svaki od najmanje dva susjedna višenamjenska aminokiselinska ostatka razgranate jezgre; mnoštvo višenamjenskih aminokiselinskih ostataka, pri čemu su dva ili više peptida koji vežu fibrinogen odvojeno kovalentno vezani na najmanje jedan od višenamjenskih aminokiselinskih ostataka razgranate jezgre; ili mnoštvo multifunkcionalnih aminokiselinskih ostataka, pri čemu su dva ili više multifunkcionalnih aminokiselinskih ostataka kovalentno povezani preko bočnog lanca susjednog multifunkcionalnog aminokiselinskog ostatka; pri čemu višefunkcionalni aminokiselinski ostaci sadrže tri- ili tetra-funkcionalne aminokiselinske ostatke, ili tri- i tetra-funkcionalne aminokiselinske ostatke.
2. Pripravak prema zahtjevu 1, naznačen time što mnoštvo multifunkcionalnih aminokiselinskih ostataka sadrži lizin, ornitin, arginin, asparaginsku kiselinu, glutaminsku kiselinu, asparagin, glutamin, ili ostatak cisteina.
3. Pripravak prema zahtjevu 1, naznačen time što je svaki peptid koji veže fibrinogen vezan za razgranatu jezgru pomoću nepeptidnog poveznika, izborno pri čemu poveznik sadrži ravno-lančani poveznik, poželjno ravno-lančanu alkilnu skupinu, i izborno pri čemu poveznik sadrži -NH(CH2)nCO-, gdje je n 1-10.
4. Pripravak prema bilo kojem prethodnom zahtjevu, naznačen time što hemostatsko sredstvo sadrži peptide koji vežu fibrinogen različite sekvence, izborno pri čemu mnoštvo nosača sadrži prvo mnoštvo nosača i drugo mnoštvo nosača, i gdje su peptidi koji vežu fibrinogen vezani na prvu množinu nosača različitog slijeda od peptida koji vežu fibrinogen vezanih na drugu množinu nosača, izborno gdje svaki nosač ima peptide koji vežu fibrinogen različitog slijeda vezane na njega, i izborno gdje peptidi koji vežu fibrinogen različitog slijeda imaju različitu selektivnost vezanja na rupu 'a' preko rupe 'b' fibrinogena.
5. Pripravak prema zahtjevu 4, naznačen time što peptidi koji vežu fibrinogen od različite sekvence sadrže prvi peptid koji veže fibrinogen koji se preferencijalno veže na rupu 'a' fibrinogena preko rupe 'b' fibrinogena, i drugi peptid koji veže fibrinogen koji se veže s većom selektivnošću vezanja na rupu 'a' fibrinogena preko rupe 'b' fibrinogena od prvog peptida koji veže fibrinogen, izborno pri čemu prvi peptid koji veže fibrinogen sadrži aminokiselinsku sekvencu GPRP- (SEQ ID NO: 1) na njegov amino-terminalni kraj, i izborno pri čemu drugi peptid koji veže fibrinogen sadrži aminokiselinsku sekvencu -APFPRPG (SEQ ID NO: 14) na svom karboksi-terminalnom kraju.
6. Pripravak prema zahtjevu 4, naznačen time što peptidi koji vežu fibrinogen od različite sekvence sadrže prvi peptid koji veže fibrinogen koji se preferencijalno veže na rupu 'a' fibrinogena preko rupe 'b' fibrinogena, i drugi peptid koji veže fibrinogen koji se veže preferirano na rupu 'b' fibrinogena preko rupe 'a' fibrinogena, izborno pri čemu prvi peptid koji veže fibrinogen sadrži aminokiselinsku sekvencu GPRP-(SEQ ID NO: 1) na svom amino-terminalnom kraju, i izborno pri čemu drugi peptid koji veže fibrinogen sadrži aminokiselinsku sekvencu GHRP- (SEQ ID NO: 10), poželjno aminokiselinsku sekvencu GHRPY- (SEQ ID NO: 11), na svom amino terminalnom kraju.
7. Pripravak prema bilo kojem prethodnom zahtjevu, naznačen time što je biokompatibilna tekućina vodena otopina, i izborno pri čemu je vodena otopina slana otopina.
8. Pripravak prema bilo kojem prethodnom zahtjevu, naznačen time što polisaharid sadrži glikozaminoglikan, oksidiranu celulozu, kitozan, hitin, alginat, oksidirani alginat, ili oksidirani škrob, i izborno pri čemu glikozaminoglikan sadrži hijaluronsku kiselinu.
9. Pripravak prema bilo kojem prethodnom zahtjevu, naznačen time što čestice sadrže umrežene granule hijaluronske kiseline, pri čemu većina granula ima promjer u rasponu od 100-1500 µm u djelomično ili potpuno hidratiziranom obliku.
10. Pripravak prema bilo kojem prethodnom zahtjevu, naznačen time što je pripravak proziran.
11. Pripravak prema bilo kojem prethodnom zahtjevu, naznačen time što se koristi kao lijek i izborno za uporabu u liječenju krvarenja ili u liječenju rane.
12. Postupak za izradu sterilnog, spremnog za uporabu, tekućeg hemostatskog pripravka, koji sadrži: miješanje zajedno biokompatibilne tekućine, topljivog hemostatskog sredstva, i čestica biokompatibilnog umreženog polisaharida prikladnog za uporabu u hemostazi i koji su netopljivi u biokompatibilnoj tekućini, pri čemu topivo hemostatsko sredstvo sadrži mnoštvo nosača i mnoštvo peptida koji vežu fibrinogen imobiliziran na svaki nosač, pri čemu svaki nosač hemostatskog sredstva sadrži razgranatu jezgru na koju su peptidi koji vežu fibrinogen odvojeno kovalentno vezani; i steriliziranje pripravka; pri čemu razgranata jezgra sadrži: od dva do deset multifunkcionalnih aminokiselinskih ostataka, pri čemu je svaki peptid koji veže fibrinogen odvojeno kovalentno vezan na multifunkcionalni aminokiselinski ostatak razgranate jezgre; mnoštvo višenamjenskih aminokiselinskih ostataka, pri čemu su jedan ili više peptida koji vežu fibrinogen zasebno kovalentno vezani za svaki od najmanje dva susjedna višenamjenska aminokiselinska ostatka razgranate jezgre; mnoštvo višenamjenskih aminokiselinskih ostataka, pri čemu su dva ili više peptida koji vežu fibrinogen odvojeno kovalentno vezani na najmanje jedan od višenamjenskih aminokiselinskih ostataka razgranate jezgre; ili mnoštvo multifunkcionalnih aminokiselinskih ostataka, pri čemu su dva ili više multifunkcionalnih aminokiselinskih ostataka kovalentno povezani preko bočnog lanca susjednog multifunkcionalnog aminokiselinskog ostatka; pri čemu višefunkcionalni aminokiselinski ostaci sadrže tri- ili tetra-funkcionalne aminokiselinske ostatke, ili tri- i tetra- funkcionalne aminokiselinske ostatke.
13. Pripravak prema zahtjevu 1, naznačen time što je hemostatski pripravak steriliziran sterilizacijom parom, ili sterilizacijom suhom toplinom, ili postupak prema zahtjevu 12, pri čemu je pripravak steriliziran sterilizacijom parom, ili sterilizacijom suhom toplinom.
14. Pripravak prema zahtjevu 1 ili 13, naznačen time što biokompatibilna tekućina osigurava kontinuiranu tekuću fazu, i čestice polimera su uglavnom homogeno raspršene kroz tekuću fazu, ili postupak prema zahtjevu 12 ili 13, pri čemu se tekućina, sredstvo i čestice miješaju pod uvjetima koji su učinkoviti za formiranje kontinuirane tekuće faze koja sadrži čestice uglavnom homogeno raspršene kroz tekuću fazu, čime se formira suštinski homogeni hemostatski pripravak.
15. Postupak prema bilo kojem od zahtjeva 12 do 14, koji nadalje sadrži centrifugiranje mješavine za uklanjanje mjehurića zraka iz mješavine.
HRP20240065TT 2015-05-11 2016-05-11 Hemostatički pripravci HRP20240065T1 (hr)

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GBGB1508024.5A GB201508024D0 (en) 2015-05-11 2015-05-11 Haemostatic compositions
PCT/GB2016/051346 WO2016181137A1 (en) 2015-05-11 2016-05-11 Haemostatic compositions
EP16723460.8A EP3294353B1 (en) 2015-05-11 2016-05-11 Haemostatic compositions

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US (1) US11246958B2 (hr)
EP (1) EP3294353B1 (hr)
JP (1) JP6877360B2 (hr)
KR (1) KR102645212B1 (hr)
CN (1) CN107592814B (hr)
AU (1) AU2016261108B2 (hr)
BR (1) BR112017024162A2 (hr)
CA (1) CA2983798A1 (hr)
GB (1) GB201508024D0 (hr)
HR (1) HRP20240065T1 (hr)
IL (1) IL255579A (hr)
MX (1) MX2017014418A (hr)
PH (1) PH12017501946A1 (hr)
RU (1) RU2744694C2 (hr)
WO (1) WO2016181137A1 (hr)

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