PURIFICATION PROCESS OF MONTELUKAST AND ITS AMINE SALTS

Postupak za pročišćavanje Montelukasta, ili njegove farmaceutski prihvatljive soli, ili njegovog solvata, uključujući bilo koji stereoizomer ili njegovu mješavinu naznačen time da se sastoji od pretvaranja kiseline Montelukasta ili njegovog solvata, uključujući bilo koji stereoizomer ili njegovu mješavinu, u sol amina koja je odabrana iz skupine koju čine L-(+)-treo-2-amino-1-fenil-1,3-propandiol i sol L-(+)-α-fenilglicinola, u prisutnosti odgovarajućeg otapala. Patent sadrži još 14 patentnih zahtjeva. It comprises a process for the purification of Montelukast, or its salts or its solvates, including any stereoisomer or mixture thereof, which comprises converting Montelukast acid or a solvate thereof, including any stereoisomer or mixtures thereof, into an amine salt selected from the group consisting of cyclohexylamine, tris-(hydroxymethyl)aminomethane, L-(+)-treo-2-amino-1-phenyl-1,3-propanediol, R-(+)-±-methylbenzylamine, and L-(+)-±-phenylglycinol salt, in the presence of an appropriate solvent. It also comprises novel salts of Montelukast, in particular, cyclohexylamine, tris-(hydroxymethyl)aminomethane, L-(+)-treo-2-amino-1-phenyl-1,3-propanediol, R-(+)-±-methylbenzylamine, and L-(+)-±-phenylglycinol salts.