Softpellets – a new production equipment

Myriam Reineke, Hanna Schliemann & Regina Scherließ

Department of Pharmaceutics and Biopharmaceutics, Kiel University Grasweg 9a, 24118 Kiel, Germany

Summary

The Vibro-Pelletiser 2.0 is a novel piece of equipment for the continuous manufacturing of softpellets. In this process, the powder is first pre-agglomerated via sieving, followed by mechanical rounding on a vibrating metal slide. Several process parameters, such as the frequency and amplitude of the vibrating motor, the sieving speed and the slide angle, can be precisely controlled. This method provides an alternative to conventional batch production and enables scalable, reproducible production of spherical agglomerates. The softpellets were produced from InhaLac500 (MEGGLE GmbH & Co. KG, Wasserburg Germany) and the resulting softpellets were compared with untreated InhaLac500 to show the advantages of the new shape (MEGGLE GmbH & Co. KG, Wasserburg Germany). The resulting softpellets were characterised using dynamic image analysis (QicPic), revealing an increased median size of the agglomerate size (x50 = 87.18 µm) and improved sphericity (x50 = 0.84) compared to untreated InhaLac500 agglomerates (x50 = 73.12 µm, sphericity = 0.79). Consequently, flowability improved from moderate (Hausner ratio = 1.27) to satisfactory (Hausner ratio = 1.20). To assess the dispersibility, the softpellets were dispersed at 1 bar using the HELOS system. The measured particle size after dispersion (x50 = 5.09 µm) was almost identical to that of untreated InhaLac500 (x50 = 4.33 µm), indicating that the softpellets sufficiently deagglomerated into their primary particles. This study demonstrates the feasibility of vibration-based continuous softpellet production.