Early Compaction Studies and Their Significance
Compaction studies conducted on single-station presses enable early anticipation of issues like capping, low tensile strength, or speed sensitivity using minimal material. However, results from single-station presses do not always scale directly to rotary presses due to different compression dynamics. Comparative testing, for example between a direct-compression APAP blend and a wet granulated formulation, frequently shows superior tensile strength and robustness for wet granulated tablets—especially under rotary press conditions. This underscores the importance of evaluating tabletability across multiple press types.
Understanding Formulation Performance Profiles
Ideal formulations produce tablets with tensile strengths above 1 MPa, demonstrating stability across varied compaction pressures and manufacturing speeds. Conversely, formulations that exhibit a sharp drop in tensile strength beyond specific pressure or velocity thresholds are considered high risk. For such cases, techniques like pre-compression can de-aerate the powder blend, improving tablet strength—though this should never replace sound formulation practices.
Benefits of Thorough Development
Investing time in detailed formulation development yields significant benefits:
- Minimizes production delays and scale-up failures
- Supports adaptation to raw material variability and equipment differences
- Enables process normalization, including adjustments to dwell time and punch velocity, easing transition from lab to production floor
Prioritizing detailed formulation development is key to achieving consistent tablet quality, reducing manufacturing risk, and ensuring efficient scale-up in pharmaceutical production.
