Claims (12)
1. Stabilni, tekući pripravak, naznačen time što sadrži protein koji je protutijelo, sol i pufer; gdje se ukupna koncentracija navedene soli i pufera kreće između 5 i 100 mM, gdje je koncentracija soli 50 mM ili manja, te gdje je koncentracija pufera 50 mM ili manja; te koji ima pH između 5,0 i 7,0, primjerice 6,0 ili 6,5; gdje je protutijelo protiv monoklonsko protutijelo TFPI, HzTFPI4F36, opisano u WO2010/072691, gdje su aminokiselinski sljedovi lakog i teškog lanca HzTFPI4F3 dani u SEQ ID NO: 21 odnosno 24 u WO2010/072691.1. A stable, liquid preparation, characterized in that it contains a protein that is an antibody, a salt and a buffer; where the total concentration of said salt and buffer ranges between 5 and 100 mM, where the salt concentration is 50 mM or less, and where the buffer concentration is 50 mM or less; and which has a pH between 5.0 and 7.0, for example 6.0 or 6.5; wherein the anti-TFPI monoclonal antibody, HzTFPI4F36, is described in WO2010/072691, wherein the amino acid sequences of the light and heavy chains of HzTFPI4F3 are given in SEQ ID NO: 21 and 24, respectively, in WO2010/072691.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što se ukupna koncentracija soli i pufera kreće između 5 i 85 mM.2. The preparation according to claim 1, characterized in that the total concentration of salt and buffer ranges between 5 and 85 mM.
3. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1-2, naznačen time što je koncentracija soli 45 mM ili manja, primjerice 40 mM ili manja, primjerice 35 mM ili manja, primjerice 25 mM ili manja.3. Preparation according to any one of claims 1-2, characterized in that the salt concentration is 45 mM or less, for example 40 mM or less, for example 35 mM or less, for example 25 mM or less.
4. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačen time što se sol bira iz skupine koju čine natrijev klorid, magnezijev klorid, natrijev tiocijanat, amonijev tiocijanat, amonijev sulfat, amonijev klorid, kalcijev klorid, arginin-hidroklorid, cinkov klorid i natrijev acetat ili bilo koja njihova kombinacija.4. The preparation according to any one of claims 1-3, characterized in that the salt is selected from the group consisting of sodium chloride, magnesium chloride, sodium thiocyanate, ammonium thiocyanate, ammonium sulfate, ammonium chloride, calcium chloride, arginine hydrochloride, zinc chloride and sodium acetate or any combination thereof.
5. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što je koncentracija pufera 45 mM ili manja, primjerice 40 mM ili manja, primjerice 35 mM ili manja, primjerice 33 mM ili manja.5. A preparation according to any of claims 1-4, characterized in that the buffer concentration is 45 mM or less, for example 40 mM or less, for example 35 mM or less, for example 33 mM or less.
6. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1-5, naznačen time što je pufer histidin.6. A composition according to any one of claims 1-5, characterized in that the buffer is histidine.
7. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačen time što dodatno sadrži tenzid, primjerice polisorbat 80.7. The preparation according to any one of patent claims 1-6, characterized in that it additionally contains a surfactant, for example polysorbate 80.
8. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1-7, naznačen time što dodatno sadrži sredstvo za modificiranje toničnosti.8. The preparation according to any one of patent claims 1-7, characterized in that it additionally contains an agent for modifying tonicity.
9. Pripravak u skladu s patentnim zahtjevom 8, naznačen time što je sredstvo za modificiranje toničnosti saharoza ili manitol.9. Preparation according to patent claim 8, characterized in that the agent for modifying the tonicity is sucrose or mannitol.
10. Pripravak u skladu s bilo kojim od patentnih zahtjeva 8-9, naznačen time što je sredstvo za modificiranje toničnosti prisutno u pripravku u količini između 100 i 200 mM, primjerice 150 mM.10. A preparation according to any of claims 8-9, characterized in that the tonicity modifying agent is present in the preparation in an amount between 100 and 200 mM, for example 150 mM.
11. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1-10, naznačen time što je protein prisutan u pripravku u koncentraciji između 50 mg/ml i 300 mg/ml, primjerice koncentraciji od 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 150, 200, 250 ili 300 mg/ml.11. Preparation according to any one of patent claims 1-10, characterized in that the protein is present in the preparation in a concentration between 50 mg/ml and 300 mg/ml, for example a concentration of 50, 55, 60, 65, 70, 75 , 80, 85, 90, 95, 100, 150, 200, 250 or 300 mg/ml.
12. Farmaceutski pripravak koji sadrži pripravak u skladu s bilo kojim od patentnih zahtjeva 1-11, naznačen time što je namijenjen upotrebi u liječenju koagulopatije, primjerice hemofilije A, uz ili bez inhibitora, ili hemofilije B, uz ili bez inhibitora.12. A pharmaceutical preparation containing a preparation according to any of claims 1-11, characterized in that it is intended for use in the treatment of coagulopathy, for example hemophilia A, with or without an inhibitor, or hemophilia B, with or without an inhibitor.