Development of co-processed excipient from wheat harvest residue-derived microcrystalline cellulose suitable for formulation of immediate release tablets containing high-dose drug

The isolation of microcrystalline cellulose (MCC) from agricultural waste is one of the approaches to improve waste management and avoid potential problems due to its accumulation. Although MCC is the most common tablet diluent, its low solubility can cause problems, such as prolonged tablet disintegration and slow drug dissolution, especially in formulations containing drugs with low water solubility. This study investigates the potential to improve the characteristics of wheat harvest residue-derived MCC (MCC HR) by co-processing with mannitol, crospovidone and colloidal silicon dioxide with the aim of developing immediate-release tablets containing ibuprofen as a model of high-dose drug. Co-processing with mannitol, crospovidone and colloidal silicon dioxide led to change in particle morphology and the formation of spherical particles, but without the formation of covalent bonds and/or new chemical entities. The changes in particle size and shape did not lead to improved powder flowability. Prolonged tablet disintegration and slow drug dissolution were observed when MCC HR or samples co-processed with silicon dioxide were used in formulation of tablets containing 50% or 70% ibuprofen. The mixture obtained by co-processing MCC HR with mannitol, crospovidone and colloidal silicon dioxide was only suitable for the preparation of tablets with an ibuprofen content of up to 50%, which fulfil pharmacopoeial requirements for disintegration of immediate release tablets and ibuprofen release from such tablets.