Development of disintegrating multiple-unit tablets on a high-speed rotary tablet press.
Enteric coated bisacodyl pellets were compressed into divisible disintegrating tablets on a high speed rotary tablet press and investigated for pellet damages. The degree of pellet damages was examined via the bisacodyl dissolution during the acid treatment of' the drug release test for enteric coated articles according to USP 23. The damages depended on the type of filler-binder used and settings of the tablet press. Avicel PH 101 proved to be the most suitable filler-binder, effecting homogeneous distribution of the pellets within the tablets, as could be shown by image analysis of coloured pellets. The speed of the tablet press had noo influence on the pellet damages using Avicel PH 101 as a filler-binder, however, tablets containing 70% (w/w) of coated pellets did not fulfil the requirements of USP 23, despite optimum elasticity and coating thickness of a new Eudragit FS 30 D coating. Reducing the proportion of pellets to 60% per tablet, less than 10% of bisacodyl were released within 2 h during acid treatment thus fulfilling the requirements of the USP 23.
Wagner
K G
KG
Institut für Pharmazie, Universität Tübingen, Tübingen, Germany.
Krumme
M
M
Beckert
T E
TE
Schmidt
P C
PC
D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical
D013607:Tablets