Solubilization and stabilization of factor VIII complex
AssigneeAlpha Therapeutic Corporation
InventorsPrabir Bhattacharya, Toshiharu Motokubota
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Abstract
A process for facilitating the reconstitution of lyophilized Factor VIII complex compositions, and compositions of Factor VIII complex, which are readily reconstituted. The process of the present invention comprises providing a purified Factor VIII complex preparations; adding a stabilization agent comprising arginine; lyophilizing the stabilization agent-Factor VIII complex solutions; and reconstituting the lyophilized stabilization agent-Factor VIII complex by contacting it with solvent for less than one minute.
Claims49
A process for producing a lyophilized Factor VIII complex composition which, when reconstituted, exhibits enhanced solubility, the process comprising:
- providing an aqueous solution comprising a Factor VIII complex preparation incorporating at least 50 units of Factor VIII:C activity per milligram of total protein in the preparation;
- adding a solubilizing agent comprising arginine to the aqueous solution to thereby form a Factor VIII/arginine solution;
- and
- lyophilizing the Factor VIII/arginine solution to thereby provide a lyophilized Factor VIII composition with enhanced solubility.
A process for producing a reconstituted lyophilized Factor VIII complex composition by adding water to lyophilized Factor VIII complex composition.
A process for facilitating the reconstitution of lyophilized Factor VIII complex compositions comprising:
- providing a purified Factor VIII complex preparation in aqueous solution;
- adding a solubilization agent comprising arginine to the Factor VIII complex solution;
- lyophilizing the solubilization agent-Factor VIII complex solution;
- and
- contacting the lyophilized solubilization agent-Factor VIII complex with water for less than one minute at room temperature to reconstitute the Factor VIII complex composition.
A process for enhancing the reconstitution of lyophilized Factor VIII complex compositions and the stability of reconstituted Factor VIII complex compositions, the process comprising:
- providing a purified Factor VIII complex preparation;
- adding a solubilization agent to the Factor VIII complex preparation wherein the solubilization agent comprises arginine, histidine and human serum albumin;
- lyophilizing the solubilization agent-Factor VIII complex preparation;
- and
- contacting the lyophilized solubilization agent-Factor VIII complex with water for less than one minute to reconstitute the Factor VIII complex composition.
A lyophilized Factor VIII complex composition comprising purified Factor VIII complex and arginine, wherein the composition when contacted with water is reconstituted in less than a minute at room temperature.
A process for improving the stability of an aqueous solution of purified Factor VIII complex, the process comprising:
- providing a purified Factor VIII complex preparation;
- adding a stabilization agent to the Factor VIII complex preparation wherein the stabilization agent comprises arginine;
- lyophilizing the stabilization agent-Factor VIII complex preparation;
- and
- reconstituting the lyophilized stabilization agent-Factor VIII complex in water.
Dependencies are inferred from the claim text.