New trends in the production of pharmaceutical granules: batch versus continuous processing.
In the pharmaceutical industry, the production of granules is based on a batch concept. This concept offers many advantages with respect to quality assurance as a batch can be accepted or rejected. However, the scale-up of the batch size may lead to problems. The variety of the equipment involved often does not facilitate the scale-up process. In order to avoid scale-up problems, continuous or semi-continuous processes have to be evaluated as alternatives to a batch production. Thus, a quasi-continuous production line is presented, which permits the production of small-scale batches, e.g. for clinical trials and for large-scale batches using the same equipment.
Leuenberger
H
H
Institute of Pharmaceutical Technology, Pharmacenter of the University of Basel, Basel, Switzerland. hans.leuenberger@unibas.ch
D002626:Chemistry, Pharmaceutical; D019245:Compressive Strength; D011208:Powders; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods / Q000639:trends*
D011208:Powders