Elucidating the impact of material properties on tablet manufacturability for binary paracetamol blends

Nov. 17, 2023, midnight - by Lena Mareczek , Carolin Riehl , Meike Harms , Stephan Reichl

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Objective: While the mechanical properties of paracetamol and microcrystalline cellulose (MCC) are well-documented in the literature, there is a recognized need for a more nuanced understanding of the material properties influencing them. This study systematically examined the material properties of paracetamol-MCC blends to elucidate their impact on the mechanical properties of tablets produced through roller compaction and direct compression, with a specific focus on surface properties. Methods: Various material characteristics of binary mixtures of paracetamol and MCC, featuring different drug loads, were analyzed, with a particular emphasis on specific surface area and surface energy. Subsequently, the mechanical properties of tablets formed through direct compression and after roller compaction were investigated. Results: The study revealed that the initial material properties exerted a more pronounced impact on the mechanical properties of paracetamol-MCC blends than the processing route. This underscores the significance of material characterization in assessing the tabletability of oral solid dosage forms. Through both bivariate and multivariate analyses, key material properties influencing the tabletability of paracetamol, MCC, and their mixtures—such as surface area, surface energy, effective angle of internal friction, and density descriptors—were identified. Conclusions: This investigation underscored the importance of a comprehensive evaluation of diverse material characteristics to gain a deeper understanding of the factors influencing the mechanical properties of tablets in both direct compression and after roller compaction, using paracetamol-MCC mixtures with varying drug loads as an illustrative example. Furthermore, the study demonstrated that multivariate analysis could serve as a valuable extension to conventional bivariate analysis, unveiling underlying correlations of material properties.

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