The role of compaction simulator equipment in formulation design

Abstract

The assessment of the compaction performances of pharmaceutical powders is an important aspect of tablet product design, development and manufacturing. Compaction simulators have potential applications in pharmaceutical research anddevelopment in terms of studying basic compaction mechanisms, troubleshooting, various process variables, compactiondata library creation, scale-up parameters, and fingerprinting of new active pharmaceutical ingredients (APIs) or excipients.The upscaling of the compaction process between early R&D and production can be time-consuming and costly, resulting ina long time-to-market and shorter commercial lifecycles. Due to the limited availability and high price of a new APIs duringearly drug development phases, compaction simulators have proven highly valuable as the dwell time and punch speed canbe set accurately to mimic bottom and upper punch movement on a rotary tablet press.Many issues inherent in the formula ingredients or acquired from previous processes can be avoided or reduced if appliedcorrectly. However, if adequate attention is not paid to understanding the compaction behaviour of what is being pressed,this process may also be the source of several other problems. Pharmaceutical scientists now use a variety of instrumentedpresses to produce robust tablet formulations. They allow scientists to conduct experiments for in-depth analysis of compaction characteristics of pharmaceutical materials with great efficiency in terms of time, expense, and knowledge gained. Theability to use simulators for anything from early formulation studies to manufacturing troubleshooting makes them invaluable, particularly in light of the recent Process Analytical Technology (PAT)/Ouality by design (QbD) phenomenon.