Roller compaction is often utilized as the first step to improve flow properties and homogeneity of pharmaceutical mixtures. Since the dry granulation process is less complicated than its counterparts in the industry, it is possible to perform screening experiments readily to investigate granulate quality for further operations. In this study, the aim of the investigation focused on the effect of roller compaction on the dissolution of granules and tablets of two pharmaceutical formulations that contain APIs of different biopharmaceutical classification. This study underscores the benefits of granule dissolution testing as a crucial early-stage technique for optimizing granulate quality and facilitating progression through formulation manufacturing operations. For active pharmaceutical ingredients characterized by poor dissolution properties, this approach provides valuable insights during the initial development phases. By integrating granule dissolution testing into the development process, product manufacturability can be enhanced and optimal product performance can be ensured.

Department of Organic Technology Faculty of Chemical Technology University of Chemistry and Technology Technická 5 166 28 Prague Czech Republic

University of Applied Sciences and Arts Northwestern Switzerland School of Life Sciences Hofackerstrasse 30 4132 Muttenz Switzerland

Zentiva k s U Kabelovny 130 102 00 Prague Czech Republic

Citace poskytuje Crossref.org