Improved stability of OPALMON tablets under humid conditions. III: Application of the rotary vacuum drying method to dry Opalmon tablets.
In stability studies on moisture-resistant Opalmon tablets in press-through-packages (PTP), which were placed in aluminum bags, we found that the degradation rate of the dextran formulation is faster than that of the lactose formulation. The fast degradation of the dextran formulation is attributed to residual moisture in the package because drying the tablets before packaging suppressed the degradation and there is a good correlation between the stability of the drug and the water-activity of the tablets. Therefore, we developed a new drying method for the tablets, i.e. the rotary vacuum drying method, and investigated the effects of the operating conditions such as heating temperature, rotation speed, and vacuum degree on the drying time, and the appearance of the tablets. Using the rotary vacuum drying method, the tablets were dried over a short time (30 min) on a mass production scale so that the water activity was less than 0.03. Furthermore, the tablets suffered negligible damage such as breaking and chipping during the drying process. These results indicate that the rotary vacuum drying method is useful for drying tablets on mass production scales.
Sekiya
Noboru
N
Pharmaceutical Development Laboratories, Ono Pharmaceutical Co., Ltd., Osaka, Japan sekiya@ono.co.jp
Abe
Nobutaka
N
Yamamoto
Masanobu
M
Takeda
Kazuhisa
K
D003911:Dextrans / Q000737:chemistry; D004355:Drug Stability; D006358:Hot Temperature; D006813:Humidity; D013607:Tablets / Q000737:chemistry*
D003911:Dextrans; D013607:Tablets