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Last Updated: March 29, 2024

Claims for Patent: 7,037,895


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Summary for Patent: 7,037,895
Title:Albumin-based colloid composition and method of use in treating hypovolemia and multiorgan dysfunction
Abstract: A composition comprising an albumin-based colloid and its use in treating hypovolemic conditions such as capillary leak syndrome and shock are disclosed.
Inventor(s): Assaly; Ragheb (Sylvania, OH), Dignam; John D. (Perrysburg, OH), Shapiro; Joseph I. (Toledo, OH)
Assignee: Medical College of Ohio (Toledo, OH)
Application Number:10/106,793
Patent Claims:1. A composition for treating hypovolemic conditions comprising at least one PEGylation product of an albumin-based colloid having a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries wherein albumin has a molecular excluded volume and the molecular excluded volume of the PEGylation product is 16 fold larger than the molecular excluded volume of the albumin.

2. A composition for treating hypovolemic conditions comprising at least one PEGylation product of an albumin-based colloid having a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries wherein albumin has a hydrodynamic radius and the hydrodynamic radius of the PEGylation product is 13 fold larger than the hydrodynamic radius of the albumin.

3. The composition of claim 1, wherein the albumin-based colloid comprises polyethylene glycol modified albumin composition.

4. The composition of claim 1, wherein the albumin-based colloid has a number average molecular weight of 128,000 daltons using colloid osmotic pressure measurement.

5. The composition of claim 1, wherein the PEGylation product has a hydrodynamic/gyration radius (R.sub.G)of 10 nm.

6. The composition of claim 1, wherein the albumin-based colloid is human albumin, bovine serum albumin, lactalbumin, or ovalbumin.

7. The composition of claim 1, wherein the albumin-based colloid has an ability to bind ligands.

8. The composition of claim 7, wherein the ligands comprise sodium ions, fatty acids, bilirubin and therapeutic drugs.

9. The composition of claim 1, wherein the PEGylation product has a half-life greater than albumin.

10. An in vivo method of preventing hypovolemic conditions comprising administering a therapeutic amount of an albumuin-based colloid composition to a patient at risk of injury and multiorgan dysfunction due to hypovolemic conditions.

11. A method for the prevention of mammalian tissue injury from at least one hypovolemic condition comprising the administration of a therapeutic amount to a mammal of a composition comprising an albumin-based colloid, the composition being incapable of leaking through the mammal's capillaries and being present in an amount sufficient to protect said tissue from injury.

12. The method of claim 11, where the risk of injury is due to sepsis, shock, burn, trauma, surgery, predisposition to capillary leak, hyperviscosity states, hypoalbuminemia, leukopheresis, nutritional albumin deficiency, nephrotic syndrome, liver failure, and/or anoxia.

13. The method of claim 12, in which the composition is used as a hyperosmotic agent driving ultrafiltration in peritoneal dialysis patients.

14. A method for forming an albumin-based colloid comprising modifying at least one albumin with at least one polyethylene oxide wherein the albumin is modified by using N-hydroxysuccinamide esters.

15. A method for forming an albumin-based colloid comprising modifying at least one albumin with at least one polyethylene glycol wherein the albumin is modified by using cyanuric-chloride derivatives, comprising the steps of dissolving albumin in potassium phosphate to form an albumin solution; activating methoxy polyethylene glycol with cyanuric chloride and dissolving in water to form a methoxy polyethylene glycol solution; adding the methoxy polyethylene glycol solution to the albumin solution to form a mixture; stirring the mixture for a suitable time at about room temperature; dialyzing the mixture against a phosphate buffered saline solution at about 4.degree. C. for a suitable time, and collecting polyethylene glycol modified albumin.

16. The method of claim 15, in which the serum albumin is human albumin, bovine serum albumin, lactalbumin, recombinant albumin or ovalalbumin.

17. The method of claim 15, in which the ratio of a volume of the methoxy glycol solution to a volume of the albumin solution is in the range of about 1 to about 3.

18. The method of claim 10, in which the polyethylene glycol has a molecular weight of 5,000 or greater based on SDS.

19. An in vivo method of treating hypovolemic conditions in a patient having hypovolemic conditions and/or multiorgan dysfunction comprising administering a therapeutic amount of an albumin-based colloid composition.

20. The composition of claim 1 wherein the PEGylation product has a hydrodynamic/gyration radius (R.sub.G) of 10 nm.

21. An in vivo method of treating hypovolemic conditions comprising administering a therapeutic amount of an albumin-based colloid composition to a patient at risk of injury and multiorgan dysfunction due to hypovolemic conditions.

Details for Patent 7,037,895

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 ⤷  Try a Trial 2021-03-27
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2021-03-27
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2021-03-27
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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