EVALUATION OF ERA-TAB AS A DIRECT COMPRESSION EXCIPIENT

The physical and compressional properties of a modified rice starch, E ra-Tab, were evaluated and compared with those of 4 commercially avail able direct compression excipients, namely, microcrystalline cellulose (Avicel PH-101), partially pregelatinized starch, spray-dried lactose (Super-Tab Lactose), and granular dicalcium phosphate dihydrate (Emco mpress). It was found that Era-Tab possessed high flowability and adeq uate compressibility. The compacted material made with Era-Tab has a h igher crushing strength and a lower friability than 3 other direct com pression excipients, except microcrystalline cellulose. Tablets contai ning terfenadine of the same degree of hardness (approximate to 10 kg) were also prepared using different direct compression excipients. The disintegration time of the tablets made with Era-Tab was approximatel y 2.5 min. The maximum of the accumulated percentage of terfenadine re leased from the tablet reached 90%, and 63.2% of it was released withi n 20 min. Both the powder characteristics and tablet properties show t hat the modified rice starch, Era-Tab, is a useful product as a direct compression tablet excipient.