Multi Stage Strategy to Reduce Friability of Directly Compressed Orally Disintegrating Tablets

Abstract

The aim of the presented work describes the formulation of compressed orally disintegrating tablet (ODT) using α-tocopheryl polyethylene glycol 1000 succinate (TPGS) as a binder/disintegrant. Preliminary investigations were focused on process and formulation optimisation which resulted in ODT containing 2% wt. TPGS with reasonable hardness and acceptable disintegration time but with high friability. The next stage of the work was to systematically investigate various strategies to overcome high friability including hot-cold cycle of powder blending to promote interparticular adhesion, size separation of diluent, influence of compression force and incorporation of crospovidone. The study concluded that friability was controlled by multi-strategic approach which resulted in reduction from 3.16% to 1%. Keywords: Direct compression, orally disintegrating tablets, friability, interparticulate, mannitol, particle size, morphology, dysphagia, paediatric, geriatric, pharmaceutical, freeze drying, meticulous, synchronisation, α-tocopheryl.