期刊
CRYSTAL GROWTH & DESIGN
卷 12, 期 4, 页码 1717-1726出版社
AMER CHEMICAL SOC
DOI: 10.1021/cg200356x
关键词
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资金
- DGI, Spain [CTQ2006- 06333/BQU, CTQ2010- 019501, NAN2004-09159-C04-01]
- DGR, Catalunya [2005SGR 00591]
- Instituto de Salud Carlos III, through Acciones CIBER
- VI National R Plan
- Iniciativa Ingenio
- Consolider Program
- CIBER Actions
- Instituto de Salud Carlos III
- European Regional Development Fund
- MICINN
- CSIC
- TECNIO network
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 CO2-expanded solvents can be modulated through appropriate variations of process parameters - CO2 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.
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