Comparative evaluation of the physicochemical and disintegrant properties of starch from five improved varieties of cassava in paracetamol tablet formulations

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Starch has been employed in pharmaceutical industries extensively as diluents, binding agents and disintegrants in tablet formulations and various studies have been conducted to develop novel starches from local sources for use as excipients. The objective of this study was to determine the physicochemical and tablet disintegrant properties of starches obtained from five improved cassava varieties to assess their potential as disintegrants substitute for the pharmaceutical manufacturing industry. The cassava varieties used were Sika Bankye, Ampong, AW/ 10 / 008, 12/ 0245 and 12/0197 and were assigned with codes V10, V20, V30, V40 and V50, respectively. The cassava starches were obtained by wet separation techniques and the organoleptic properties of the starches were determined to be fine texture, odourless, bland taste and white in colour. The physicochemical properties of the starches namely: pH, moisture content, angle of repose, solubility, bulk and tapped densities, Hausner‟s ratio and Carr‟s index were determined to assess their suitability for pharmaceutical use. The percentage yield of the starches ranged from 7.97 – 26.82 % with V50 and V20 having the lowest and highest starch yield, respectively. The particle density, bulk density and tapped density of the starches followed the same pattern of V20 > V30 > V50 > V40 > V10. All the starches had particle size distributed from 162.2μm – 177.5μm. All the starches showed good swelling and water retention capacities with an order of swelling power of V30 > V20 > V40 > V10 > V50. The toxic metal analysis showed an insignificant amount of arsenic, lead, cadmium and mercury, suggesting the safety of the cassava starches for use as pharmaceutical excipient. FTIR study confirmed there was no interaction of the starches with the pure paracetamol powder. The uniformity of weight, tensile strength, hardness and friability of the paracetamol tablets containing different concentrations of the cassava starches as disintegrant were not significantly different (p > 0.05) from compacts vi containing the commercial disintegrant, maize starch. The cassava starches caused faster tablet disintegration and the release of paracetamol from the cassava starches showed comparative effectiveness as disintegrants to compacts containing maize starch at the same concentration. The Crushing strength-friability (CSFR) and Crushing strength-friability/ disintegration time (CSFR/DT) values of tablets containing cassava starches were high (formed strong tablets) and were comparable to compacts containing maize starch at the same concentration. All tablets containing different concentrations of starch passed the dissolution and assay tests for immediate release dosage forms. The results obtained establish the suitability for pharmaceutical use of the cassava starches as disintegrants with comparable properties to the commercially available maize starch.
A thesis submitted to the school of Graduate Studies in partial fulfillment of the requirement for the degree of master of science (Pharmaceutical Technology), 2016.