Multiple unit pellet systems (MUPS) obtained by soft compaction of two polymorphic cellulose modifications as coated pellets: influence of the polymorphic modification in MUPS on disintegration time and drug release

Abstract

The compaction of UICEL-A/102 and MCC 102 coated pellets into multiple unit pellet systems (MUPS) is presented in this work. MCC 102 and UICEL-A/102 were separately mixed with sodium diclofenac, pelletised and afterwards coated with a water suspension of Kollicoat® SR 30 D. 30%-50% of the so produced coated pellets were embedded in 40%-60% of MCC 102 powder (cushioning) and 10% of either STA-RX® 1500 or UICEL-A/102 (disintegrant). Finally, the tabletting mixtures were compacted into MUPS using a PressterTM Compaction Simulator. Both UICEL-A/102 and MCC 102 MUPS resulted to be mechanically robust (crushing strength of 70-100 N), fast disintegrating in water and maintained the same release profile and similar superficial and inner morphology compared to the uncompressed subunits. UICEL-A/102 proved to be more appropriate as filler for immediate release pellets and MUPS, whereas MCC 102 confirmed to be advantageous filler for controlled release pellets in MUPS.