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

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Compaction into multi-unit pellet system (MUPS) tablets can damage sustained release pellet coatings.
• This damage compromises the functional polymer layer and desired drug release profile.
• Existing mitigation strategies often involve complex processes or specialized materials.

Purpose of the Study:

• To investigate the potential of native, unprocessed starches as a simple filler material to mitigate compaction-induced damage to coated pellets.
• To evaluate the effect of different native starches (rice, tapioca, corn, potato) on pellet coat integrity and MUPS tablet properties.

Main Methods:

• Sustained release pellets with ethylcellulose or acrylic coats were prepared.
• These pellets were compacted into MUPS tablets using filler materials containing microcrystalline cellulose and varying concentrations (25% or 40% w/w) of native starches.
• MUPS tablet tensile strength and the extent of pellet coat damage were quantitatively assessed.

Main Results:

• While starches reduced overall tablet strength, rice and tapioca starches most effectively mitigated pellet coat damage (10-44% reduction, p < 0.008).
• Higher starch concentrations and compaction pressures enhanced this protective 'cushioning' effect.
• Acrylic-coated pellets showed greater benefit from starch addition compared to ethylcellulose-coated pellets.

Conclusions:

• Native starches, particularly rice and tapioca, offer a simple and effective method to reduce pellet coat damage during MUPS tablet manufacturing.
• The cushioning effect is attributed to filler material properties like reduced plastic deformation and increased particle rearrangement.
• This approach presents a viable strategy for preserving the integrity of sustained release coatings in MUPS tablets.