Scaling up a high shear granulation process to gain granules suitable to formulate orally disintegrating tablets

In regard to line extensions or improving administration convenience, orally disintegrating tablets (ODTs) have become a popular dosage form over the last years. Nowadays, the formulator has some ready-to-use aids on hand, allowing quick and simple drug formulation [1]. The application of these ready-to-use aids is limited, though. Certain formulation aspects such as high drug load or dedicated market demands (e.g. price sensitive markets) might call for customised ODT formulations. In order to match these special requirements, a formulation based on crospovidone and lactose (agglomerated with native maize starch) was developed. This formulation proved to result in orally disintegrating tablets offering superior features (e.g. quick disintegration, high crushing strength) [2–6]. Even upon stability, formulations based on these excipients showed an excellent performance [7]. The aim of this work was to scale-up the granulation process of lactose with starch paste, on which the whole ODT formulation is based. Investigating the crucial parameters impeller speed and granulation time on three different levels was supposed to deliver additional insights on the robustness of both formulation and process. The product gained was evaluated, formulated and compressed with a subsequent characterisation of the resulting tablets.

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Kollidon CL-SF (458) - ODT up-scaling (C
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