Claims for Patent: 5,204,324

Summary for Patent: 5,204,324

Title:	Biologically competent, virus inactivated albumin
Abstract:	Biologically competent non-pasteurized albumin wherein virus present in the source fluid has been inactivated with one or more of a class of compounds exemplified by glycyrrhizin, glycyrrhizinic acid or glycyrrhetinic acid glycoside, and analogous triterpenes, e.g. carbenoxolone and cicloxolone and their derivatives, and blood substitutes comprising such albumin and hemoglobin are disclosed.
Inventor(s):	Shanbrom; Edward (Santa Ana, CA)
Assignee:
Application Number:	07/433,605
Patent Claims:	1. A therapeutic composition of matter consisting essentially of non-pasteurized biologically competent human albumin substantially separated from plasma and other blood components, substantially free of stabilizers and free of active virus and suitable for human therapy, containing one or more glycyrrhizic triterpenoid compounds. 2. A therapeutic composition of matter consisting essentially of non-pasteurized biologically competent human albumin substantially separated from plasma and other blood components, substantially free of stabilizers and free of active virus and suitable for human therapy, containing one or more glycyrrhizic triterpenoid compounds in an amount of from 0.0001 to 10 wt/% based on human albumin effective to inactivate susceptible viruses found in fluids from which the human albumin was derived. 3. The non-pasteurized albumin of claim 2 wherein the concentration of glycyrrhizic triterpenoid compounds is from about 0.05 wt % to about 3 wt %. 4. A method for preparing biologically competent, virus inactivated human albumin suitable for human therapy comprising mixing a concentrate of human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers and which has not been pasteurized; with one or more glycyrrhizic triterpenoid compounds the resulting albumin composition comprising, during preparation, an amount between 0.0001 and 10 weight percent of glycyrrhizic triterpenoid compound sufficient to inactivate pathogenic virus therein. 5. A method for preparing biologically competent, virus inactivated human albumin suitable for human therapy comprising mixing a concentrate of human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers and which has not been pasteurized; with one or more glycyrrhizic triterpenoid compounds in a concentration of from 0.0001 to 10.0 wt/% based on human albumin sufficient to substantially inactivate susceptible viruses. 6. The method of claim 5 wherein the glycyrrhizic triterpenoid compounds is present in a concentration of from about 0.05 to about 3 wt/% in the human albumin. 7. Blood substitute consisting essentially of hemoglobin and non-pasteurized human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers and being suitable for human therapy, containing one or more glycyrrhizic triterpenoid compounds the albumin composition comprising, during preparation, an amount between 0.0001 and 10 weight percent of glycyrrhizic triterpenoid compound sufficient to inactivate pathogenic virus therein. 8. Blood substitute consisting essentially of hemoglobin and non-pasteurized human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers and suitable for human therapy, containing one or more glycyrrhizic triterpenoid compounds in an amount of from 0.0001 to 10 wt/% effective to inactivate susceptible viruses found in fluids from which the human albumin was derived. 9. Blood substitute comprising hemoglobin and non-pasteurized albumin containing one or more glycyrrhizic triterpenoid compounds in an amount of from 0.0001 to 10 wt/% effective to inactivate susceptible viruses found in fluids from which the albumin was derived. 10. The blood substitute of claim 9 wherein the concentration of glycyrrhizic triterpenoid compounds is from about 0.05 wt % to about 3 wt %. 11. A method for preparing blood substitute comprising (a) mixing together hemoglobin, (b) biologically competent, virus inactivated human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers, which has not been pasteurized and which is suitable for human therapy, the albumin composition comprising, during preparation, an amount between 0.0001 and 10 weight percent of glycyrrhizic triterpenoid compound sufficient to inactivate pathogenic virus therein and (c) one or more glycyrrhizic triterpenoid compounds. 12. A method for preparing blood substitute comprising mixing together (a) hemoglobin, (b) biologically competent, virus inactivated human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers, which has not been pasteurized and which is suitable for human therapy and (c) one or more glycyrrhizic triterpenoid compounds in a concentration of from 0.0001 to 10.0 wt/% sufficient to substantially inactivate susceptible viruses. 13. The method of claim 12 wherein the glycyrrhizic triterpenoid compounds is present in a concentration of from about 0.05 to about 3 wt/%. 14. A method of preparing a therapeutic composition of matter consisting of human albumin suitable for human therapy substantially saturated with one or more glycyrrhizic triterpenoid compounds comprising the steps of: adding one or more glycyrrhizic triterpenoid compounds to human albumin-containing serum in an amount of from about 0.25 wt % to about 15 wt % to cause human albumin to precipitate; and recovering the precipitate consisting essentially of human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers and substantially saturated with one or more glycyrrhizic triterpenoid compounds. 15. The product of the process of claim 14. 16. A method of preparing a therapeutic composition of matter consisting essentially of human serum human albumin suitable for human therapy substantially saturated with one or more glycyrrhizic triterpenoid compounds comprising the steps of: adding one or more glycyrrhizic triterpenoid compounds to human serum in an amount of from about 0.25 wt % to about 15 wt % to cause human albumin to precipitate; and recovering the precipitate consisting essentially of human serum human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers and substantially saturated with one or more glycyrrhizic triterpenoid compounds. 17. The product of the process of claim 16. 18. A method for preparing a therapeutic composition of matter consisting essentially of biologically competent, virus inactivated human albumin suitable for human therapy comprising mixing a concentrate of human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers; with one or more glycyrrhizic triterpenoid compounds, the albumin composition comprising, during preparation, an amount between 0.0001 and 10 weight percent of glycyrrhizic triterpenoid compound sufficient to inactivate pathogenic virus therein and maintaining the mixture of human albumin and glycyrrhizic triterpenoid compound at a temperature of about 37.degree. C. for a period of at least about one hour. 19. A method for preparing a therapeutic composition of matter consisting essentially of biologically competent, virus inactivated human albumin suitable for human therapy comprising mixing a concentrate of human albumin, said albumin being substantially separated from plasma and other blood components, substantially free of stabilizers and which has not been pasteurized, with one or more glycyrrhizic triterpenoid compounds in a concentration of from 0.0001 to 10.0 wt/% based on human albumin sufficient to substantially inactivate susceptible viruses and maintaining the mixture of human albumin and glycyrrhizic triterpenoid compound at a temperature of about 37.degree. C. for a period of at least about one hour. 20. The method of claim 19 wherein the glycyrrhizic triterpenoid compounds is present in a concentration of from about 0.05 to about 3 wt/% in the human albumin.

Details for Patent 5,204,324

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2008-11-23
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2008-11-23
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2008-11-23
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2008-11-23
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2008-11-23