The recently published USP Chapter <1062> Tablet Compaction Properties defines key Critical Quality Attributes for manufactured tablets. These are calculated from compaction pressure, tablet density or solid fraction and tensile fracture stress. The Gamlen® Dashboard system measures all of these parameters, and many more to provide you with complete and useful compaction data. Using our unique powder assessment system, you will be able to better understand you APIs and formulations and avoid tableting problems. The Gamlen® Dashboard displays how a material compares with industry norms for the key parameters of compaction, lubrication and elastic recovery. The clearly defined “good” and “poor” compaction behaviour zones aid result interpretation and allow even novice users to identify problematic data. We can also set the good and bad limits to suit your company’s expectations or the particular requirements of your formulations. The graphs automatically scale to show your formulation along with the configuration ranges you use. WHAT INFORMATION WILL THE GAMLEN SOFTWARE GIVE YOU? TABLETABILITY Will your product make a strong but porous tablet? Maximising tabletability is a key objective for formulation and process development. COMPACTIBILITY Is your product at risk of over-compaction? Products with very high density are much more likely to result in capping. They are also slower to dissolve and over-compaction can introduce flaws weakening the tablets LUBRICATION PROBLEMS Measurement of detachment (take-off) force and ejection force gives acts as an early warning system for picking, sticking and capping. The Dashboard software will help you optimise formulation lubrication. ELASTIC RECOVERY Is your formulation prone to capping? As the tablet emerges during ejection, the section of the tablet outside the die undergoes elastic recovery and expands. Excessive elastic recovery at this stage can cause capping. VISUAL REPRESENTATION OF FORMULATION/PROCESS CHANGES With the Gamlen Dashboard software you will be able to evaluate formulation and process changes at a glance and easily compare the compaction behaviour of your APIs, excipients and formulations.
MEASUREMENTS: - Compaction force/displacement - Detachment force/displacement - Ejection force/displacement - Tablet weight - Tablet thickness - Tablet diameter - Tablet breaking strength CALCULATIONS - Compaction pressure - Detachment stress - Ejection stress - Tablet tensile strength - Tablet solid fraction - Tablet volume - Tablet density - Tablet elastic recovery - G ratio DATA DISPLAYED - Compressibility - Tabletability - Compatibility - Detachment stress profile - Ejection stress profile - Sawai Plot - Elastic Recovery profile - G ratio profile