Tobacco stalk nanofibrillated cellulose: An eco-friendly binder on fluidized bed granulation

The search for new excipients that provide formulation alternatives over existing ones and that are derived from natural resources has advanced over the years. Emerging from this scenario, an important alternative to traditional excipients is nanofibrillated cellulose (NFC), which is generally obtained from agricultural wastes and is a cellulose-rich material. Most of the time, the nanofibers are presented in aqueous dispersions that form a highly entangled network of fibrous particles that exhibit gel-like behavior. Therefore, the present work aimed to explore the gel-like behavior of NFC from tobacco stalks to evaluate it as a binder in a fluid bed granulation process for further application as a pharmaceutical ingredient. The granulation process was carried out using top spray mode with an inlet air temperature of 80 °C, airflow between 9 and 11 mm³ h⁻¹, and atomizing air pressure of 0.7 bar. Povidone (PVP) was used as a standard binder for comparison purposes. The binder systems were sprayed on the powder blend of theophylline and maltodextrin at a feed rate of 3.05 mL⋅min⁻¹. Granule properties, such as yield, moisture content, morphology, label-free Raman imaging, particle size distribution, drug content, and flow properties, were evaluated. The process using NFC provided granules with excellent drug uniformity, low moisture content (<2 %), high yield (>92 %), and passable flow properties. Their behavior was comparable to that of granules prepared with the classical PVP binder system. Therefore, this study opens a perspective for the reuse of NFC from tobacco stalk, an agricultural waste, as an alternative binder for the granulation process, contributing to environmental sustainability.