Semicontinuous granulation—the process of choice for the production of pharmaceutical granules?

Tablets represent the majority of dosage forms sold worldwide. High-quality granules are a prerequisite for a robust manufacturing of millions and millions of tablets needed. Thus, the preparation of pharmaceutical granules is an important standard operation procedure in the pharmaceutical industry. Due to the pressure on the costs of medication, there is a constant search for new concepts to reduce the manufacturing costs and the time to market keeping simultaneously constant or even improving the quality of the product. With respect to this trend, the following questions and problems will be treated in detail. (1) Is it possible to replace in the pharmaceutical industry the batch-type manufacturing process for granules by a quasi-continuous or continuous process being successfully introduced in the food industry? (2) Can scale-up problems be avoided by introducing a quasi-continuous process? (3) Using a continuous process, is it possible to keep or even to improve the high quality of the granules? (4) Is it possible to increase the productivity? (5) What will be the cost savings using a quasi-continuous process compared to the classical batch-type procedure? (6) Is it possible to shorten the development time, i.e. the time to market for a new product using a continuous or quasi-continuous manufacturing process for pharmaceutical granules? (7) What type of organizational business model is needed to achieve the desired results? Experiences with a new quasi-continuous equipment, the Glatt MulticellR, will be presented as a case study.