Enhanced multi-component model to consider the lubricant effect on compressibility and compactibility
Modeling of structural and mechanical tablet properties consisting of multiple components, based on a minimum of experimental data is of high interest, in order to minimize time- and cost-intensive experimental trials in the development of new tablet formulations. The majority of commonly available models use the compressibility and compactibility of constituent components and establish mixing rules between those components, in order to predict the tablet properties of formulations containing multiple components. However, their applicability is limited to single materials, which form intact tablets (e.g. lactose, cellulose) and therefore, they cannot be applied for lubricants.
Lubricants are required in the majority of industrial tablet formulations and usually influence the mechanical strength of tablets. This study combines the multi-component compaction model of Reynolds et al. (2017) with a recently published lubrication model (Puckhaber et al. 2020) to describe the impact of multiple components on a formulation consisting of two diluents and a lubricant. By that, this model combination displays a meaningful extension of existing compaction models and allows the systematic prediction of properties of lubricated multi-component tablets.
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Materials
As diluents, microcrystalline cellulose (MCC; Vivapur 102®, JRS Pharma, Germany), anhydrous lactose (LAC, Lactose Anhydrous NF DT, Kerry, Ireland) and dicalcium phosphate (DCP, DI-CAFOS A150, Budenheim, Germany) were used. For lubrication, magnesium stearate (MgSt, Faci, Italy) was applied after being desagglomerated using a 355 µm sieve.
Daniel Puckhaber, Anna-Lena Voges, Supriya Rane, Sarah David, Bindhumadhavan Gururajan, Jan Henrik Finke, Arno Kwade, Enhanced multi-component model to consider the lubricant effect on compressibility and compactibility, European Journal of Pharmaceutics and Biopharmaceutics, 2023, ISSN 0939-6411, https://doi.org/10.1016/j.ejpb.2023.04.004.
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