Article history: The present study aimed to evaluate the physical stability on amorphous solid dispersion (SD) of Received 29 August 2011 cyclosporine A (CsA) employing hydroxypropyl cellulose (HPC). SD formulations (5–30% CsA) of CsA such Received in revised form 8 December 2011 wet-milled SD (WM/SD) and freeze-dried SD (FD/SD) were prepared, and both SD formulations were Accepted 11 January 2012 stored at 40 C/75% relative humidity for 8 weeks. Transitions in morphology, dissolution behavior, crys- Available online 20 January 2012 tallinity and thermal behavior of CsA were evaluated. There was at least 84-fold improvement in initial dissolution rate of SD formulations compared with that of amorphous CsA powder, although their disso- Keywords: lution rate was gradually decreased under accelerated conditions. In particular, aged FD/SD with a drug Cyclosporine A load of 30% exhibited highly limited dissolution as evidenced by 40% reduction of solubility after 8 weeks Amorphous of storage. In contrast, aged WM/SD exhibited less reduction in dissolution rate compared with FD/SD. No Solid dispersion signiﬁcant changes were seen in crystallinity and thermal behavior after aging of SD formulations for 8 Solid solution Stability weeks; however, electron microscopic observations revealed aggregation of drug molecules/particles in the aged FD/SD, possibly
International Journal of Pharmaceutics – Elsevier
Published: Apr 15, 2012
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