Stavudine Polymorphic Form 1 process

摘要

A process for the formation of Stavudine Polymorphic Form I from a mixture comprising Polymorphic Form I and at least one of Polymorphic Forms II and III is disclosed using the technique of Solution-Enhanced Dispersion by Supercritical Fluids (SEDS). A solution of the mixture in isopropyl alcohol/water is introduced into a particle formation vessel with a supercritical fluid under controlled temperature and pressure whereby the supercritical fluid substantially simultaneously disperses and extracts the solvent from the solution forming discrete particles of Stavudine Polymorphic Form I. A preferred supercritical fluid is carbon dioxide.