Process for the production of multi-dose pharmaceutical preparations containing isolated or recombinantly produced human protein for infusion or injection purposes
First Claim
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1. A process for the production of preserved isolated or recombinantly produced human protein-containing pharmaceutical preparations suitable for use as injection or infusion solutions in the form of multi-dose preparations, comprising forming a solution of the isolated or recombinantly produced human protein and at least one preservative selected from the group consisting of chlorobutanol, benzyl alcohol, benzalkonium chloride and mixtures thereof, in the absence of a mineral suspension, wherein the concentration of the preservative in the multi-dose preparation is 0.001 to 2 w/v %.
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Abstract
The present invention concerns a process for the production of well-tolerated, preserved injection or infusion solutions containing human protein.
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Citations
66 Claims
- 1. A process for the production of preserved isolated or recombinantly produced human protein-containing pharmaceutical preparations suitable for use as injection or infusion solutions in the form of multi-dose preparations, comprising forming a solution of the isolated or recombinantly produced human protein and at least one preservative selected from the group consisting of chlorobutanol, benzyl alcohol, benzalkonium chloride and mixtures thereof, in the absence of a mineral suspension, wherein the concentration of the preservative in the multi-dose preparation is 0.001 to 2 w/v %.
- 18. A pharmaceutical preparation in the form of a multidose-formulation comprising an aqueous solution containing an isolated or recombinantly produced human protein and 0.001 to 2 w/v % of at least one preservative selected from the group consisting of chlorobutanol (1,1,1-trichloro-2-methyl-2-propanol), benzyl alcohol, benzalkonium chloride and mixtures thereof in the absence of a mineral suspension.
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34. A kit for the preparation of a human protein-containing pharmaceutical injection or infusion solution, comprising a packaged lyophilized human protein and a separately packaged aqueous reconstitution solvent containing a preservative selected from the group consisting of chlorobutanol, benzyl alcohol, benzalkonium chloride and mixtures thereof in an amount to provide a concentration of the preservative in the injection or infusion solution of 0.001 to 2 w/v %, wherein said kit does not contain a mineral suspension.
- 35. A process for the production of preserved human protein-containing pharmaceutical preparations suitable for use as injection or infusion solutions in the form of multi-dose preparations, comprising forming an aqueous solution of the human protein and a mixture of at least two preservatives selected from the group consisting of chlorobutanol, benzyl alcohol and benzalkonium chloride in the absence of a mineral suspension, wherein the concentration of the preservatives in the multi-dose preparation is 0.001 to 2 w/v %.
- 51. A pharmaceutical preparation comprising an aqueous solution containing a human protein and 0.001 to 2 w/v % of a mixture of at least two preservatives selected from the group consisting of chlorobutanol(1,1,1-trichloro-2-methyl-2-propanol), benzyl alcohol and benzalkonium chloride in the absence of a mineral suspension, said preparation in the form of a multi-dose formulation.
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66. A kit for the preparation of a human protein-containing pharmaceutical injection or infusion solution, comprising a packaged lyophilized human protein and a separately packaged aqueous reconstitution solvent containing a mixture of at least two preservatives selected from the group consisting of chlorobutanol, benzyl alcohol and benzalkonium chloride in an amount to provide a concentration of the preservatives in the injection or infusion solution of 0.001 to 2 w/v %, wherein the kit does not contain a mineral suspension.
Specification