Claims for Patent: 4,330,507

Summary for Patent: 4,330,507

Title:	Method and system for generating and collecting gallium-68 using alkaline eluant
Abstract:	A method for generating Ga-68 from Ge-68 is provided that comprises contacting a substrate on which Ge-68 has been adsorbed with an alkaline solution having a pH of at least about 12 and thereby eluting Ga-68. Preferably the Ga-68 is eluted in the form of the gallate ion. A generator system comprises a generator column containing Ge-68 and Ga-68, a sealed eluant container having a predetermined quantity of eluant comprising an alkaline solution having a pH of at least about 12, and an evacuated eluate collection vial having a vacuum sufficient to draw the desired quantity of eluate into the eluate collection vial. The eluate collection vial can contain a neutralizing agent and also a diagnostically useful complexing agent.
Inventor(s):	Lewis; Robert E. (Milford, NH)
Assignee:	New England Nuclear Corporation (Boston, MA)
Application Number:	06/158,395
Patent Claims:	1. A method for generating an eluate containing Ga-68 in ionic form, said method comprising contacting an alkaline solution having a pH of at least about 12 with a substrate on which Ge-68 has been adsorbed, thereby eluting Ga-68 in the solution. 2. The method in accord with claim 1 wherein said substrate is alumina and said method further includes loading said substrate with Ge-68 by adsorption from a solution having a pH in the range of from about 7.0 to 8.0. 3. The method in accord with claim 1 wherein the pH of said solution is in the range of about 12 to 13. 4. The method in accord with claim 1 wherein said solution comprises sodium hydroxide. 5. The method in accord with claim 1 wherein said solution comprises sodium phosphate. 6. A Ge-68/Ga-68 generator system for providing Ga-68, said system comprising a generator column containing Ge-68 and Ga-68, a sealed eluant vial containing a predetermined quantity of eluant comprising an alkaline solution having a pH of at least about 12, and an evacuated eluate collection vial having a vacuum at least sufficient to draw the desired quantity of eluate into the eluate collection vial. 7. The generator system in accord with claim 6 wherein said eluant container comprises sufficient eluant for one elution. 8. The generator system in accord with claim 6 wherein said eluant container contains sufficient eluant for the useful life of the generator. 9. The generator system in accord with claim 8 wherein said eluant container comprises a water-tight collapsible container. 10. The generator system in accord with claim 6 wherein said eluate collection vial further contains sufficient vacuum to draw air through the generator column to leave the column bed damp-dry. 11. The system in accord with claim 6 wherein said eluant vial contains sodium hydroxide. 12. The system in accord with claim 6 wherein said eluant vial contains sodium phosphate. 13. The system in accord with claim 6 wherein the solution in said eluant vial is prepared by injecting sterile water into a sealed vial containing a predetermined quantity of eluant solids. 14. The system according to claim 6, including a plurality of said eluant vials and a plurality of said eluate collection vials for a plurality of elutions. 15. The generator system in accord with claim 6 wherein said eluate collection vial further contains a predetermined quantity of a neutralizing agent to neutralize or buffer the eluate. 16. The generator system of claim 15 wherein said eluate collection vial contains a predetermined quantity of diagnostically useful complexing agent for the Ga-68. 17. The generator system of claim 16 wherein said neutralizing agent and said complexing agent is citric acid. 18. A method for generating an eluate containing Ga-68 in non-complexed ionic form, comprising passing a predetermined quantity of eluant from an eluant container through a generator column containing Ge-68 and Ga-68 to form an eluate, and receiving said eluate in a pre-evacuated eluate collection vial having sufficient vacuum to draw said predetermined quantity of eluant through said column and into the eluate collection vial, said eluant comprising an alkaline solution having a pH in the range of from about 12 to 13. 19. The method in accord with claim 18 further comprising the step of opening said generator column to the atmosphere after passing said predetermined quantity of eluant through the column, and drawing sufficient air through the column to leave it damp-dry.

Details for Patent 4,330,507

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		2039-09-23