An evaluation of microcrystalline cellulose attributes affecting compaction-induced pellet coat damage through a multi-faceted analysis

Pellet coat damage in multi-unit pellet system (MUPS) tablets has previously been studied and addressed with limited success. The effects of lactose filler material attributes on pellet coat damage have been relatively well-studied but a similar understanding of microcrystalline cellulose (MCC) is lacking notwithstanding its high cushioning potential. Hence, the relationships between MCC attributes and pellet coat damage were investigated. Single pellet in minitablets (SPIMs) were used to isolate pellet-filler effects and reveal the under-unexplored impact of risk factors found in MUPS tablets. MUPS tablets and SPIMs were prepared with various grades of MCC and pellets with an ethylcellulose or acrylic coat at various compaction pressures.

Subsequently, the extent of pellet coat damage was determined by dissolution test and quantified using two indicators to differentiate the nature of the damage. A multi-faceted analytical approach incorporated linear regression, correlations and a classification and regression tree algorithm and evaluated how MCC attributes, such as flowability, particle size and plastic deformability, exert various influences on the extent of ethylcellulose and acrylic pellet coat damage. This analysis improved the understanding of the different mechanisms by which pellet coat damage to these two polymer types occurs which can help enhance future pellet coat damage mitigation strategies.

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Materials

Metformin hydrochloride (MET; Granules India Limited, India) was used as the model drug. Sugar cores (Suglets® 500-600 μm, Colorcon, USA) were the starter cores for drug layering, followed by sustained release coating. Hydroxypropyl methylcellulose (Methocel VLV, Dow Chemical, USA) and polyvinylpyrrolidone (Plasdone C-15, Ashland, USA) were used for drug layering. Two types of sustained release coating were evaluated – ethylcellulose (EC) and acrylic (AC) coats.

Daniel Robin Thio, Quinton Aguilera, Janice Ke Xin Yeoh, Paul Wan Sia Heng, Lai Wah Chan, An evaluation of microcrystalline cellulose attributes affecting compaction-induced pellet coat damage through a multi-faceted analysis, International Journal of Pharmaceutics, 2023, 123245, ISSN 0378-5173, https://doi.org/10.1016/j.ijpharm.2023.123245.

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