Physicochemical stability study on cyclosporine A loaded dry-emulsion formulation with enhanced solubility

Chemical & Pharmaceutical Bulletin
Hideyuki SatoSatomi Onoue

Abstract

The main purpose of the present study was to evaluate the physicochemical stability of cyclosporine A (CsA)-loaded glycerol monooleate-based dry emulsion (DE). DE formulations containing 5-25% CsA (DE5-25) were stored at 25°C/60% relative humidity for 4 weeks, and freeze-dried solid dispersion formulations containing 5-30% CsA (FD5-30) were also prepared as reference formulations. Even after the storage, no significant changes were observed in the appearance of any formulations. In the dissolution study, both DE and FD exhibited marked enhancement of solubility and there was at least 2.0-fold improvement in the initial dissolution rate of DE formulations compared with that of FD formulations. After storage, DE5, DE15 and FD5 maintained relatively high solubility, with 10% reduction compared with the initial state. However, the solubility of DE25 gradually decreased during storage, as evidenced by 76% reduction of the dissolution amount. No significant changes were seen in DE5-25 using powder X-ray diffraction, although thermal analysis revealed moderate changes in crystallinity in DE25 after storage, possibly leading to the decreased dissolution. Furthermore, particle size distributions of micelles in DE5 and DE15 were almost u...Continue Reading

References

Mar 1, 1986·British Journal of Clinical Pharmacology·A JohnstonD W Holt
Jun 17, 2004·AAPS PharmSciTech·Rajesh R Dubey, Rajesh H Parikh
Mar 28, 2006·International Journal of Pharmaceutics·Guy Van den MooterNorbert Blaton
Oct 20, 2011·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Satomi OnoueShizuo Yamada
Jan 31, 2012·International Journal of Pharmaceutics·Hideyuki SatoSatomi Onoue

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Citations

Jan 31, 2017·Journal of Agricultural and Food Chemistry·Hideyuki SatoSatomi Onoue

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