Crystallization of microparticulate pure polymorphs of active pharmaceutical ingredients using CO <inf>2</inf>-expanded solvents

Santiago Sala, Alba Córdoba, Evelyn Moreno-Calvo, Elisa Elizondo, Maria Muntó, Paula Elena Rojas, Maria Àngels Larrayoz, Nora Ventosa, Jaume Veciana

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    14 Citations (Scopus)

    Abstract

    The feasibility of the Depressurization of an Expanded Liquid Organic Solution (DELOS) method to process different active pharmaceutical ingredients (APIs) as finely divided powders with narrow particle size distribution, high crystallinity degree, high polymorphic purity, and free from residual solvent has been demonstrated. Cholesterol, acetylsalicylic acid (aspirin), naproxen, acetaminophen, and ibuprofen were chosen as model drugs. It has been demonstrated that the supersaturation ratio attained during crystallization from CO 2-expanded solvents can be modulated through appropriate variations of process parameters - CO 2 content and concentration of the initial solution. In view of the potential application that compressed fluids-based technologies have in the pharmaceutical industry, a preliminary scalability study of the process in compliance with the constraints imposed by the Good Manufacturing Practices (GMP) specifications is presented herein. © 2012 American Chemical Society.
    Original languageEnglish
    Pages (from-to)1717-1726
    JournalCrystal Growth and Design
    Volume12
    Issue number4
    DOIs
    Publication statusPublished - 4 Apr 2012

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