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. (C) 2001 Published by Elsevier Science B.V.