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US 11,279,784 B2Granted
Preparations of meta-iodobenzylguanidine and precursors thereof
AssigneeMolecular Insight Pharmaceuticals, Inc.
InventorsJason Moss, Machinani Rao
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Abstract
The present disclosure provides purified forms of iobenguane and preparations of a precursor to iobenguane, such as a polymer, the polymer comprising a monomer of formula (I) or a pharmaceutically acceptable salt thereof, the preparation comprising leachable tin at a level of 0 ppm to 850 ppm.
Claims17
A method for preparing a purified composition of a polymer comprising a monomer of formula (I):
- or a pharmaceutically acceptable salt thereof,
- the method comprising the steps of:
- counter ion exchange of a hydrochloric acid form of the monomer of formula (I) with sodium acetate to thereby provide a preparation comprising the monomer of formula (I) in the form of a HOAc salt;
- a first solvent treating step, comprising contacting the preparation with aqueous alcohol, and then removing substantially all of the aqueous alcohol;
- a second solvent treating step, comprising contacting preparation with anhydrous alcohol, and then removing substantially all of the anhydrous alcohol so that a solvent-depleted material comprising the polymer is generated;
- and
- subjecting the solvent-depleted material to vacuum, and to a temperature within a range of about 30° C. to about 50° C., the subjecting being performed under conditions and for a time sufficient to thereby provide the purified composition of the polymer, or pharmaceutically acceptable salt thereof;
- wherein no more than 150 ppm of leachable tin is present in the purified composition of the polymer.
5 more elements
Dependencies are inferred from the claim text.