Controlled-release domperidone pellets compressed into fast disintegrating tablets forming a multiple-unit pellet system (MUPS)

Abstract

Controlled release dosage forms are essential when the drug release rate impacts the effectiveness of therapy. In the present study, a modified-release dosage form of domperidone was developed in the form of pellets, which were subsequently compressed into a tablet to disintegrate and be swallowed by patients, without changing the release profile. Sustained-release pellets of domperidone prepared by the extrusion-spheronization and layering technique using Celphere® 102 (microcrystalline cellulose spheres) and Suglet® (sugar spheres) as core seed, subsequently coated with Kollicoat® SR 30 D (polyvinyl acetate dispersion) as rate controlling polymer, were developed using the multiple unit pellet system (MUPS) as a plateform technology. Then, 2ˆ3 full factorial design (two level and three parameters) was applied to assess the impact of the different variables on the properties of the resulting pellets prepared by extrusion-spheronization. Different types of tableting excipients were combined for better pellet compressibility. The combination of Ceolus® granules (granules prepared using a fibrous grade of microcrystalline cellulose) and Ludipess® (lactose based co-processed excipient) was found as a suitable tableting excipient for MUPS preparation. The MUPS based sustained-release domperidone formulation prepared using Celphere® 102 was found to possess rapid disintegration properties, hardness, and unaltered release profile even after compression.