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 the critical material attributes on the design space of the production of lysozyme pellets with suitable biological and physical properties for the subsequent coating process. The effect of two brands of both lysozyme and conformation stabilizing mannitol on the behavior of the composition in an extrusion/spheronization process was studied, while the experiments were designed according to 2³ factorial design.

The kneading of the mass was carried out in a high shear granulator equipped with a specially designed granulation chamber (Opulus Ltd, Hungary) constructed with seven built-in sensors for the measurement of temperature and relative humidity (RH). The special chamber is a novel tool for the identification of the critical points during processing a thermolabile drug by providing the online monitoring of critical environmental parameters and could be used to accurately determine the effect of critical process parameters and material attributes.

The prepared samples were investigated for their biological and physical properties. It was found that the critical material attributes have a potential effect on the production process and product quality, and highly influence the size of the process design space. Therefore, the screening of the formulation materials is a key factor in macromolecular drug development.

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Materials: Conventional crystalline (Hungaropharma Ltd., Budapest, Hungary) and directly compressible spray-dried (Pearlitol SD-200, Roquette Pharma, France) mannitol (referred to as CM and SDM, respectively) served as conformation stabilizers.

Article information: Yousif H-E.Y. Ibrahim, Patience Wobuoma, Katalin Kristó, Ferenc Lajkó, Gábor Klivényi, Béla Jancsik, Géza Regdon jr, Klára Pintye-Hódi, Tamás Sovány. Effect of processing conditions and material attributes on the design space of lysozyme pellets prepared by extrusion/spheronization, Journal of Drug Delivery Science and Technology, 2021. https://doi.org/10.1016/j.jddst.2021.102714.