Claims for Patent: 8,597,613

Summary for Patent: 8,597,613

Title:	Radiolabeled lymphatic staining agents and methods for making
Abstract:	A radiolabeled lymphatic staining agent is mixed on site with a much larger amount, on a weight basis, of a non-radiolabeled lymphatic staining agent to form an injectable radiolabeled lymphatic staining agent suitable for surgical use in humans. Preferably, the radiolabel is I-125, because it has a 60-day half-life which enables it to be made off-site. The preferred radiolabeled lymphatic staining agent is iodinated methylene blue, because it can be mixed with a range of non-radioactive lymphatic staining agents, for example isosulfan blue, methylene blue, patent blue, and patent blue V, to provide the injected agent with sufficient radioactivity to enable machine detection. A method for making radioiodinated methylene blue is also disclosed.
Inventor(s):	Maloney; Thomas J. (Friendswood, TX), Camp, Jr.; Arthur E. (Richmond, TX), Hernandez; Jesse J. (Alvin, TX)
Assignee:	Iso-Tex Diagnostics, Inc (Friendswood, TX)
Application Number:	10/884,561
Patent Claims:	1. A method comprising contacting phenothiazin-5-ium-3,7-bis(dimethylamino)-chloride and an I-125 radioactive iodine isotope in the presence of an iodogen oxidizing agent coated on a support to form a radiolabeled derivative of methylene blue which has been iodinated with the I-125 radioactive iodine isotope, wherein the contacting is further conducted in the presence of iodide and iodate anions, wherein the iodide and iodate anions are provided in the form of a solution of sodium iodide and calcium iodate. 2. A method as in claim 1 wherein the contacting is further conducted in the presence of acetate anions. 3. A method as in claim 1 wherein the contacting is further conducted under acidic conditions. 4. A method as in claim 1 wherein the contacting is further conducted at a temperature in the range of 75 to 100 degrees C. 5. A method as in claim 1 further comprising flowing the radiolabeled derivative of methylene blue through an anion exchange column to remove unreacted I-125 and collecting purified radiolabeled derivative of methylene blue from the column. 6. A method as in claim 5 further comprising, prior to flowing the radiolabeled derivative of methylene blue through the anion exchange column, conditioning the column with sodium hydroxide, sterile water, hydrochloric acid, and sodium chloride. 7. A method as in claim 2 wherein the acetate anions are provided in the form of a solution of sodium acetate and acetic acid. 8. A method as in claim 3 wherein the acidic conditions are provided by acetic acid.

Details for Patent 8,597,613

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		2039-09-22