Assessing granulation behavior across twin-screw wet granulation platforms: Pharma-11 vs. ConsiGma-1

Sept. 3, 2026, midnight - by Catarina Luz , Slavomira Doktorovová , José Granjo , Rodrigo Neto , João F. Pinto , Ricardo Sousa

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Continuous twin-screw wet granulation (TSWG) is a robust alternative to conventional batch granulation for the manufacture of solid oral dosage forms. However, differences in equipment design can lead to distinct granulation behaviours, making the transferability between systems an important consideration during process development. This study investigated the practical transferability between two geometrically different granulators, Pharma-11 and ConsiGma-1 (CG-1), and evaluated how equipment design, process parameters, and formulation variables affect granule and tablet properties. A design of experiments (DoE) approach was used to assess the effects of formulation composition, liquid-to-solid (L/S) ratio, and screw speed. Different screw configurations were evaluated in the Pharma-11, including configurations with and without distributive mixing elements (DMEs), and compared with the size control element (SCE) configurations used in the CG-1. Granule size distribution (GSD) analysis showed that the CG-1 produced larger granules, reaching approximately 2 mm, whereas Pharma-11 granules were limited to approximately 1 mm, reflecting differences in barrel diameter. When granule size was normalized to the respective barrel dimensions, the volume-weighted mean diameter (dv) values showed close agreement between the two systems. Further calibration reduced the observed differences and resulted in highly comparable GSD profiles. The incorporation of DMEs in the Pharma-11 reduced the proportion of fines while generating granules with a size distribution comparable to that obtained with the CG-1. Overall, the results demonstrate that equipment geometry, screw configuration, and operational constraints can significantly influence granulation behaviour and product attributes. Although Pharma-11 is not typically used as a standard platform for TSWG development, it can produce granules comparable to those generated by the CG-1 when operated within its technical limitations. These findings support the use of Pharma-11 as an effective early-stage development tool, particularly when material availability is limited or process optimization is required.

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