Abstract: A method of coprocessing a limited solubility bioactive agent with a compatible aid comprising: (a) identifying a compatible aid for the bioactive agent; (b) either (i) forming a co-dissolved solution of the compatible aid and bioactive agent in a common solvent or (ii) forming a solution of the compatible aid in an anti-solvent and forming solution of the bioactive agent in a solvent; and (c) forming a film or primary particles from the co-dissolved solution or solutions of step (b), which film or primary particles comprise bioactive agent in crystalline form, with the crystals having average diameter of 1 micron or less.

Abstract: 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.