Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 99, Issue 4, Pages 1997-2007Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.21967
Keywords
co-spray drying; amorphous; SBA-15; poorly soluble drugs; stability; rapid release
Funding
- Institute of Chemical Engineering and Science, Agency of Science Technology and Research, Singapore
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A novel formulation process via co-spray drying ibuprofen (IBU) with mesoporous SBA-15 submicron particles exhibited excellence in production of stable amorphous IBU with significantly enhanced dissolution rate. With drug loading of IBU/SBA-15 ratio being 50:50 (w/w) or below, most drug molecules were entrapped inside the straight mesoporous channels via the co-spray drying and the morphology of SBA-15 submicron particles remained unchanged. IBU confined inside the mesoporous structure was in the amorphous state shown by PXRD and DSC measurements. The amorphous state of IBU in the solid dispersion showed remarkable stability when subject to stress test condition of 40 degrees C/75% RH in open pans for 12 months. The uniform pore walls were believed to prevent the re-crystallization of the homogeneously dispersed drug molecules inside the mesoporous channels with confined nanospace. The dissolution rate of IBU from the co-spray-dried solid dispersion was significantly enhanced to achieve a rapid release. Even after the accelerated stability test, the rapid drug release property was well preserved. (C) 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:1997-2007, 2010
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