Microcrystalline cellulose from soybean hull as an excipient in solid dosage forms: Preparation, powder characterization, and tableting properties.

ABSTRACT

Microcrystalline cellulose (MCC) is one of the essential functional excipients in the formulation of tablets. The need for cheaper MCC sources has drawn significant attention to exploring renewable sources. In this study, MCC was produced from soybean hull (SBH), the primary by-product of the soy industry, using a novel, simplified, and cost-effective approach. Various characterization techniques were used to study the physicochemical properties and micromeritics of the SBH-based MCC powders and compare them to those of the commercial Avicel PH-101. SBH MCCs had a larger particle size, a broader particle size distribution, a higher degree of polymerization, a higher degree of crystallinity, better thermal stability, and slightly superior flowability and compressibility than Avicel PH-101. The tableting blends (containing 60 % MCC) were prepared, and the post-compression out-of-die Heckel analysis showed that formulations with aggregated SBH MCCs were less ductile than those made with Avicel PH-101, resulting in a lower porosity (better compressibility) of the latter at higher compression pressures. The hardness values for all formulations were above 6 kg, with higher values for those made with Avicel PH-101. The lubricant sensitivity was lower for SBH MCCs. All tablets made using developed formulations showed very low friability (<0.1 %) and short disintegration times (<90 s), making them well-suited candidates for manufacturing orally disintegrating tablets (ODTs).