Abstract

Mini-tablets are solid dosage forms with increasing interest for pharmaceutical industry due to clinical and biopharmaceutical benefits. But technological aspects on mini-tableting are not fully investigated. Therefore, the impact of punch size and tableting pressure for industrially relevant excipients like microcrystalline cellulose, lactose, isomalt and Ludiflash® are investigated using 8 and 11.28 mm punches for conventionally sized tablets and 1,2 and 3 mm punches for mini-tablets. For evaluation of the effect of tablet size on deformation behaviour and mechanical properties, compressibility, compactibility and tabletability plots are created and evaluated. Deformation behaviour is analysed by In-Die Heckel plot and modified Weibull function. Further, specific plastic energy (SPE) profiles are generated out of force-displacement plots. The effect of the adjustment of the aspect ratio towards 1 as in conventionally sized tablets on deformation behaviour and tabletability is analysed. The effect of tablet size on deformation behaviour mainly showed lower yield pressures for conventionally sized tablets, whereas comparable SPEs were obtained with all tablet sizes. Furthermore, mini-tablets indicate better compactibility, as (depending on the excipient) higher tensile strengths were obtained at lower solid fractions. However, no superior tabletability properties are obtained for mini-tablets compared to conventionally sized tablets.

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