EXPERIENCE IN SCALING-UP THE FILM COATING PROCESS FOR THEOPHYLLINE SUSTAINED-RELEASE PELLETS

The scale-up of the film coating process for the production of Broncho retard(R) pellets (theophylline, CAS 58-55-9) is an example for the su ccessful setup of a modern production technology designed to meet the increasing GMP requirements while taking into consideration ecological and economical aspects. This technology provides a reduction in polym er losses on drying from approx. 20% to under 5% and a distinct improv ement in the reproducibility of the in vitro dissolution profiles. Dou ble batch sizes and higher spray rates allow for a substantially highe r batch turnover. A production line installed exclusively for Bronchor etard(R) pellets and specific process optimization measures resulted i n considerably lower lag-times of the equipment.