TH62917B - Stable pharmaceutical constituents with factor VIII. - Google Patents

Abstract

DC60 (23/06/46) The invention involves a solid pharmaceutical mixture consisting of factor VIII. The mixture is free from amino acids and consists of (a) factor VIII; (b) substance. surfactants (c) calcium chloride (d) sucrose (e) sodium chloride (f) trisodium citrate and (g) buffer with a pH of 6 to 8 prior to lyophilization and after dissolution in water for injection The invention is also related to liquid pharmaceutical mixtures that can be obtained after Dilute solid pharmaceutical mixture stabilized thereby by sterile water that may be chosen to have Sodium chloride is present. The invention involves a solid pharmaceutical mixture consisting of a combination of factor VIII. The mixture is free from amino acids and contains (a) factor VIII, (b) surfactant, (c) calcium. chloride (d) sucrose, (e) sodium chloride, (f) trisodium syrup, and (g) buffer with pH from 6 to 8 before lyophilization and after reconstitution in water for injection. The invention is also related to liquid pharmaceutical mixtures that can be obtained after Dilute solid pharmaceutical mixture stabilized thereby by sterile water that may be chosen to have Sodium chloride is also a patent drug.

Claims (9)

Disclaimers (all) that will not appear on the advertisement page: 1. Solid Pharmaceutical Composition That can be obtained by lyophilizing the solution Without amino acids, including (a) factor VIII (factor VIII) (b) surfactant (c) calcium chloride (d) sucrose (e) sodium chloride (f). Trisodium citrate and (g) amino-free buffers with pH from 6 to 8 before lyophilization and after dissolution in water for injection. 2. The solid pharmaceutical mixtures pursuant to claim 1 characterize the properties that Factor VIII has been selected from, or recombinant factor VIII of pigs. 3. The solid pharmaceutical admixture according to claim 2 characterizes the properties of which Factor VIII is the recombinant factor VIII of pigs. 4.The solid pharmaceutical mixture according to claim 2, characterizes the properties of Factor VIII having an amino acid sequence SEQ ID NO.1. 5. The solid pharmaceutical admixture according to any of the claims 1 to 4, characterizes the surfactant is a polysorbate. 6. The solid pharmaceutical admixture according to claim 5 characterizes that the surfactant is polysorbate 80. 7. The solid pharmaceutical admixture according to any one of Claims 1 through 6 characterizes the properties that the amino acid-free buffer is tris (hydroxymethyl) betel. L amine 8.A solid pharmaceutical admixture according to any of Claim 1 to 7, pre-lyophilized and after dissolving in water for injection, has a pH from 6.5 to 7.5. 9.A solid pharmaceutical admixture pursuant to any of Claim 1 through 8 may be obtained by lyophilization of an amino acid-free solution containing (a) part. Factor VIII concentrations range from 50 to 10,000 international units / ml for human factor VIII or recombinant factor VIII of people or from 50 to 10,000 units / ml for factor VIII of Pig or pork recombinant factor VIII (b) surfactant concentrations in the range from critical micellar concentrations to 1% v / v (c) concentrations. Of calcium chloride in the range from 0.5 to 10 mM (d), sucrose concentrations ranged from 5 to 50 mM (e), sodium chloride concentrations ranged from 0.15 to 0.5 M (f). Sodium citrate in the range from 1 to 50 mM and (g) buffer concentrations range from 1 to 50 mM 1. 0. Liquid pharmaceutical mixtures that can be obtained after dilution of pharmaceutical mixtures. Solid type according to any of Claims 1 through 9 with sterile water that may be optional Contains sodium chloride