Claims for Patent: 8,481,695

Summary for Patent: 8,481,695

Title:	Self-gelling alginate systems and uses thereof
Abstract:	Kits and compositions for producing an alginate gel are disclosed. The kits and compositions comprise soluble alginate and insoluble alginate/gelling ion particles. Methods for dispensing a self-gelling alginate dispersion are disclosed. The methods comprise forming a dispersion of insoluble alginate/gelling ion particles in a solution containing soluble alginate, and dispensing the dispersion whereby the dispersion forms an alginate gel matrix. The methods may include dispensing the dispersion into the body of an individual. An alginate gel having a thickness of greater than 5 mm and a homogenous alginate matrix network and homogenous alginate gels free of one or more of: sulfates citrates, phosphates, lactatates, EDTA or lipids are disclosed. Implantable devices comprising a homogenous alginate gel coating are disclosed. Methods of improving the viability of pancreatic islets, or other cellular aggregates or tissue, following isolation and during storage and transport are disclosed.
Inventor(s):	Melvik; Jan Egil (Oslo, NO), Dornish; Michael (Bekkestua, NO), Onsoyen; Edvar (Sande, NO), Berge; Astrid B. (Asker, NO), Svendsen; Terje (Asker, NO)
Assignee:	FMC Biopolymer AS (Sandvika, NO)
Application Number:	12/855,964
Patent Claims:	1. A method for dispensing a biomedical self-gelling alginate dispersion comprising: a) forming a dispersion by mixing: i) a solution comprising a sterile water soluble alginate with particles of a sterile water insoluble alginate or ii) sterile immediately water soluble alginate, particles of sterile water insoluble alginate and a solvent, and b) dispensing the dispersion whereby the dispersion forms an alginate gel matrix; wherein the dispersion is (i) dispensed into an individual by injection or (ii) implanted into the individual after gel formation. 2. The method of claim 1 wherein said dispersion further comprises one or more components selected from the group consisting of: a drug, a peptide, a protein, a cell, a multicellular aggregate, a tissue, a detectable label, and a contrast reagent. 3. The method of claim 2, wherein the dispersion comprises cells. 4. The method of claim 3, wherein said cells are non-proliferating cells selected from the group consisting of: pancreatic islets, hepatic cells, neural cells, renal cortex cells, vascular endothelial cells, thyroid and parathyroid cells, adrenal cells, thymic cells, ovarian cells and chondrocytes. 5. The method of claim 3, wherein said cells are proliferating cells or encapsulated cells that comprise an expression vector that encodes one or more proteins that are expressed when the cells are maintained. 6. The method of claim 2, wherein said cells are insulin-producing cells. 7. The method of claim 2, wherein the dispersion comprises tissue bulking material. 8. The method of claim 1, wherein there is an excess of water soluble alginate in comparison to water insoluble alginate. 9. The method of claim 1, wherein the concentration of water soluble alginate to water insoluble alginate is between 5:1 and 1:5. 10. The method of claim 1, wherein the particles comprise particle sizes selected from the group consisting of: <25 .mu.m, 25-45 .mu.m, 45-75 .mu.m, and 75-125 .mu.m. 11. The method of claim 10, wherein said particle sizes are obtained through sifting. 12. The method of claim 1, wherein the particles are obtained by (i) washing a precipitate of the water insoluble alginate to remove all water soluble ions as determined by comparing the conductivity of the water insoluble alginate in purified water to the conductivity of purified water, (ii) drying and (iii) forming particles from the water insoluble alginate. 13. The method of claim 1, wherein the water soluble alginate, immediately water soluble alginate and the water insoluble alginate each have endotoxin levels of <25 EU/gram. 14. The method of claim 1, wherein the dispersion is dispensed into a blood vessel of an individual. 15. The method of claim 1, wherein the dispersion is dispensed in the individual at the site of a wound. 16. The method of claim 1, wherein said dispersion is free of one or more of: sulfates, citrates, phosphates, lactates, EDTA or lipids.

Details for Patent 8,481,695

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2024-10-12