Evaluation of binders in twin-screw wet granulation – Optimization of tabletability

June 25, 2024, midnight - by Claudia Köster , Peter Kleinebudde

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This study examined the impact of hydroxypropyl cellulose (HPC) type (HPC-SSL SFP, HPC-SSL), binder concentration (2%, 3.5%, 5%), and filler type (lactose, or calcium hydrogen phosphate (DCP)/microcrystalline cellulose (MCC)) on twin-screw wet granulation and subsequent tableting. The goal was to identify the formulation with the highest tabletability that still met disintegration requirements. Using lactose with a 5% binder resulted in superior tabletability and faster disintegration compared to DCP/MCC. Tabletability of lactose formulations improved with higher binder concentrations and increased compression pressure. In contrast, DCP/MCC formulations showed improved tabletability only with higher compression pressure. However, DCP/MCC batches failed the disintegration test when both the highest binder concentration and highest compression pressure were applied. To achieve rapid disintegration, either the binder concentration or compression pressure needed to be reduced. Modifying the disintegrant type and its placement improved the disintegration of DCP/MCC tablets beyond that of lactose, but at the cost of reduced tabletability. The best results were achieved with lactose as the filler and binder concentrations of 3.5% or 5%, producing tablets with the highest tabletability and disintegration times under 500 seconds.

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