Effect of processing conditions and material attributes on the design space of lysozyme pellets prepared by extrusion/spheronization

The present work aimed to investigate the impact of critical material attributes on design space production lysozyme pellets with suitable biological and physical properties for subsequent coating process. effect two brands both conformation stabilizing mannitol behavior composition in an extrusion/spheronization process was studied, while experiments were designed according 2 3 factorial design. kneading mass carried out a high shear granulator equipped specially granulation chamber (Opulus Ltd, Hungary) constructed seven built-in sensors measurement temperature relative humidity (RH). special is novel tool identification points during processing thermolabile drug by providing online monitoring environmental parameters could be used accurately determine attributes. prepared samples investigated their properties. It found that have potential product quality, highly influence size space. Therefore, screening formulation materials key factor macromolecular development.