Native starch derived from different botanical sources as an effective co-cushioning agent in MUPS tablets

Compaction of sustained release coated pellets into multi-unit pellet system (MUPS) tablets has been associated with damage to the functional polymer layer, leading to a loss in desired sustained release function. Many filler materials and complex processes have been studied on their ability to mitigate compaction-induced pellet coat damage. Among these, native or unprocessed starches included in the filler material have not been explored well despite being a simple strategy. Sustained release pellets with ethylcellulose or acrylic coats were compacted into MUPS tablets with different filler materials, containing microcrystalline cellulose and native starch at 25 %, w/w or 40 %, w/w derived from rice, tapioca, corn, or potato. The MUPS tablet tensile strength and the extent of pellet coat damage were evaluated. Although starch weakened the tablets, rice and tapioca starch significantly mitigated pellet coat damage the most by 10 - 44 % (p < 0.008). Higher starch concentrations and higher compaction pressures led to a greater cushioning effect, which was indicated to result from reduced plastic deformation and increased particle rearrangement of the filler material. Pellets coated with acrylic benefitted more from starch and experienced less coat damage than pellets with ethylcellulose coats. This research demonstrates the use of native starches as a simple method to mitigate pellet coat damage in MUPS tablets.