Tabletting

Overview

Tableting is the unit operation where bulk solids are reduced in volume to produce the final dosage form. Three operations are integrated into the tableting processing:

1. Fill: bulk solids are filled into a die by a feed frame. The amount of fill is controlled by weight.
2. Compression: a series of punches perform an initial compression and final compaction that reduces the volume of the bulk solid to its final volume and shape
3. Ejection: the compressed tablet is removed from the die

A successful tableting operation depends on the many physical and chemical properties that include tableting equipment, the mechanical properties of the materials, lubricity of the material, die and punch adhesion, and blend uniformity. The multivariate optimization of the tableting process can be challenging in preclinical development because API is expensive. Scale-down operations provide the means to quickly obtain process information, troubleshoot, and use less API. The FFSim™ feed frame simulator enables scale-down of tablet feeds for process development or powder characterization and integrates spectroscopic PAT. A variety of compatible spectroscopic PAT techniques, including NIR, Raman, laser-induced fluorescence, and UV, can provide information on blend uniformity and indicate of there are process-related changes in API or excipient crystallinity. In a laboratory example, NIR demonstrated a highly accurate prediction for blends produced in the FFSim™.

Blend uniformity at the fill stage is often a critical quality attribute in tableting. Spectroscopic PAT is a convenient, robust, and proven approach to blend uniformity predictions. The dense powder streams of the fill may pose a fouling risk for PAT probes and flowing material does not ensure representative and consistent sampling. The µSolis™ is a “process-to-PAT” interface that collects a volume to present to the PAT and then wipes the interface window. This provides a consistent volume and clean window to improve PAT robustness.