The role of light anhydrous silicic acid on physical stability of troglitazone solid dispersion under humidified conditions

作者：Nakahashi Toshiyuki^*; Matsumoto Takahiro; Wakiyama Naoki; Moribe Kunikazu; Yamamoto Keiji

来源：Advanced Powder Technology, 2014, 25(2): 716-721.

DOI：10.1016/j.apt.2013.10.020

• Solid dispersion
• Physical stability
• Recrystallization
• Humidified condition
• Aerosil

The aim of this study was to confirm whether light anhydrous silicic acid (Aerosil) could exhibit a stabilizing effect on the physical stability of solid dispersion under humidified conditions. Ternary solid dispersions consist of 50% troglitazone, and various ratios of polyvinyl pyrrolidone and Aerosil were prepared using the co-milling method and then evaluated for their crystallizing behavior under storage conditions. The results showed that Aerosil has a stabilizing effect against crystallizing in the dihydrate of troglitazone under humidified conditions and has an appropriate ratio range (Troglitazone/PVP/Aerosil = 50/30-20/20-30) in the ternary solid dispersion, when considering total quality satisfaction such as physical stability and dissolution. Furthermore, it was found that hydrophobized Aerosil R805 has a stronger stabilizing effect than hydrophilic Aerosil 200. The stabilizing mechanism was discussed based on the comparative results and possible molecular interaction.

• 出版日期2014-3