Evaluation of tablet disintegrant properties of microcrystalline cellulose obtained from cassava fermentation waste

Abstract

This study was aimed at exploring the application of microcrystalline cellulose from cassava fermentation waste as a disintegrant in the formulation of paracetamol tablets for immediate release. Alkali delignification of the dried cassava fermentation fibres, followed by bleaching and acid depolymerisation was employed in the extraction of α-cellulose and conversion to microcrystalline cellulose (MCC). The MCC obtained was evaluated for some of its physicochemical properties. Thereafter, a comparative evaluation of paracetamol granules and tablets formulated using the MCC and Avicel^® PH 101 as disintegrants was undertaken. Drug-excipient interaction was also investigated using fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC). Results showed a 48% yield of α-cellulose from the waste material. The MCC powder was off-white in colour, insoluble in water and gritty in texture. It showed negative reaction to the presence of starch, sugar and lignin but positive to cellulose. It exhibited a moisture content and swelling capacity of 2.1 and 63.3%, respectively. The paracetamol granules formulated showed good flowability with angles of repose ≤ 31 °, Hausner’s ratios of 1.07 - 1.18 and Carr’s indices of 6.58 - 16.00%. The formulated tablets showed good hardness (> 7 kp) and friability values (≤ 0.7%). Two batches of tablets containing 7.5 or 10% (w/w) of the MCC and three batches of tablets containing Avicel® (5, 7.5 and 10% (w/w) disintegrated within 15 min. The tablets containing 5 - 10% (w/w) of the MCC or Avicel® passed the dissolution test for tablets which specifies that at least 70% of the drug should be in solution after 30 min. FTIR and DSC analyses revealed no interaction between the excipients and paracetamol. MCC from cassava fermentation waste may serve as an alternative substance to explore as a pharmaceutical excipient in solid dosage form even though its tableting parameters are not as good as those of Avicel® PH 101.

Keywords: cassava, microcrystalline cellulose, disintegrant, paracetamol granules, tablets