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Crystallization of microparticulate pure polymorphs of active pharmaceutical ingredients using CO 2-expanded solvents
Veciana, J.; Sala, S.; Córdoba, A.; Moreno Calvo, E.; Elizondo, E.; Muntó, M.; Rojas, P.E.; Larrayoz Iriarte, María Angeles; Ventosa, N.
Universitat Politècnica de Catalunya. Departament d'Enginyeria Química
The feasibility of the Depressurization of an Expanded Liquid Organic Solution(DELOS) method to process different active pharmaceutical ingredients (APIs) as finely dividedpowders 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 demonstratedthat the supersaturation ratio attained during crystallization from CO2-expanded solvents can bemodulated through appropriate variations of process parameters  CO2 content andconcentration of the initial solution. In view of the potential application that compressed fluidsbasedtechnologies have in the pharmaceutical industry, a preliminary scalability study of theprocess in compliance with the constraints imposed by the Good Manufacturing Practices (GMP)specifications is presented herein
2012-09-14
Àrees temàtiques de la UPC::Enginyeria química
Crystallization
Pharmaceutical industry
Acetyl salicylic acid
Active pharmaceutical ingredients
Depressurizations
Expanded liquid
Expanded solvents
Good Manufacturing Practices
High crystallinity
Initial solution
Model drugs
Naproxens
Organic solutions
Pharmaceutical industry
Potential applications
Process parameters
Residual solvents
Supersaturation ratio
Cristal·lització
Indústria farmacèutica
Open Access
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