[Experience in scaling up the film coating process for theophylline sustained-release pellets in mass production].
The scale-up of the film coating process for the production of Bronchoretard pellets (theophylline, CAS 58-55-9) is an example for the successful 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 polymer losses on drying from approx. 20% to under 5% and a distinct improvement in the reproducibility of the in vitro dissolution profiles. Double batch sizes and higher spray rates allow for a substantially higher batch turnover. A production line installed exclusively for Bronchoretard pellets and specific process optimization measures resulted in considerably lower lag-times of the equipment.
Klinge Pharma GmbH, München.
P
P
Grunenberg
C
C
Lorck
H
H
Jünger
A
A
Laicher
D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000191:economics; D003692:Delayed-Action Preparations; D004339:Drug Compounding; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical; D013806:Theophylline / Q000008:administration & dosage* / Q000191:economics
D018927:Anti-Asthmatic Agents; D003692:Delayed-Action Preparations; D013806:Theophylline