Application of spherical silicate to prepare solid dispersion dosage forms with aqueous polymers

作者：Nagane Kentaro; Kimura Susumu; Ukai Koji; Takahashi Chisato; Ogawa Noriko; Yamamoto Hiromitsu^*

来源：International Journal of Pharmaceutics, 2015, 493(1-2): 55-62.

DOI：10.1016/j.ijpharm.2015.07.037

• Silicate sphere
• Nifedipine
• Solid dispersion
• Vinylpyrrolidone/vinyl acetate copolymer
• Wurster-type fluidized bed granulator

The objective of this study is to prepare and characterize solid dispersions of nifedipine (NP) using porous spherical silicate micro beads (MB) that were approximately 100 mm in diameter with vinylpyrrolidone/vinyl acetate copolymer (PVP/VA) and a Wurster-type fluidized bed granulator. Compared with previously reported solid dispersion using only MB, the supersaturation of NP dissolved from the proposed system of MB and PVP/VA was maintained during dissolution tests. The proposed system produced a solid dispersion product coated on MB, and morphology was maintained after the coating process to prepare solid dispersion; therefore, the powder characteristics, such as flowability of the proposed solid dispersion product, was tremendously preferable to that of the conventional spray-dried solid dispersions of NP with PVP/VA, expecting to make the consequent manufacturing processes easy for development. Another advantage in the terms of manufacturing is its simple process to prepare solid dispersion by spraying the drug and polymer that were dissolved in an organic solvent onto a MB in a Wurster-type fluidized bed granulator, thus, simplifying the optimization and scale-up with ease.

• 出版日期2015-9-30