EVALUATION OF MODIFIED STARCHES AND MUCILAGE DISPERSIONS OBTAINED FROM IPOMOEA BATATAS L. LAM (CONVOLVULACEAE) AS BULK EXCIPIENTS IN CHEWABLE TABLET FORMULATIONS
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ABSTRACT
Increasing attention has been paid to incorporating hydrocolloids into starch-based products due to their unique functional properties and bio-safety. The aim of this work was to determine the suitability of modified starch and mucilage dispersions obtained from Ipomoea batatas as direct compression excipients in chewable tablet. Native starch (SPS) and mucilage were extracted from Ipomoea batatas. Subsequently, SPS was pregelatinized (PPS) and acid modified (APS) and dispersions of mucilage with SPS, PPS and APS in a ratio 1:20, 1:10, 2:10, 3:10 and 4:10 respectively were produced. The dispersions were characterized using standard methods for their particle size, flow properties, moisture sorption capacity, true density, porosity, hydration and swelling capacity. Pasting and thermal properties, syneresis, dilution capacity, lubricant sensitivity, compaction studies using the Heckel and Kawakita parameters, panel assessment of formulated chewable tablets and accelerated stability studies was also carried out. Generally, an increase in particle size, flow properties, moisture sorption capacity, true densities and a decrease in porosity, hydration and swelling capacity were observed as the mucilage concentration increased. Dispersions of SPS, PPS and APS in mucilage showed an increase in peak time, pasting temperature and enthalpy change as the mucilage concentration increased and a decrease in peak viscosity, syneresis (except SPS), peak temperature (except APS) as the mucilage concentration increases. Dispersions in mucilage generally led to an increase in disintegration time, crushing and tensile strength with a decrease in friability of formulated compacts (placebo). Optimized dispersions of mucilage in SPS, PPS and APS in a ratio 3:10 (i.e. 30-MSPS, 30-MPPS and 30-MAPS respectively) were used for further studies. The order of mean yield pressure (Py) for native and modified starches were APS > PPS > SPS and for their dispersions, 30-MSPS > 30-MPPS > 30-MAPS while Pk was in the order SPS > PPS > APS. In other words, modification of starch increases the plastic deformation of the native starch but reduces the viii plastic deformation of their dispersions in the order: 30-MAPS > 30-MPPS > 30-MSPS. The elastic recovery and brittle fracture index were in the order SPS > APS > PPS, while for their dispersions, which showed a decrease in elastic recovery and brittle fracture index as compared to their parent forms, were in the order; 30-MAPS > 30-MPPS > 30-MSPS. The order of dilution capacity index was MCC > 30-MPPS > 30-MAPS > 30-MSPS > mannitol. The overall order of lubricant sensitivity ratios at lower pressure was MCC < mannitol < 30- MPPS < 30-MAPS < 30-MSPS and at higher pressures, 30-MAPS < 30-MPPS < 30-MSPS < MCC < mannitol. All ascorbic acid chewable tablets made from starch dispersions were round and brown in colour without any tablet defects and had a characteristic sweet potato flavour. Generally, formulations F1 – F6 which contained starch dispersion alone had acceptable friability (< 1 %), crushing strength (> 3 Kgf) and disintegration time (< 15 min). Increase in concentrations of binary mixtures of mannitol and maltitol gave tablets with unacceptable properties. Tablets with acceptable friability, crushing strength and disintegration time were used to determine the degree of acceptance of the formulated ascorbic acid chewable tablets. Formulation F6 had the highest degree of acceptance while formulation F20 had the lowest. Formulations F4 – F6, which had higher degree of acceptance, were subjected to acceleration stability studies at 40 0C/75 % relative humidity for 3 months. There was a gradual decrease in disintegration time and crushing strength within the duration of study for all formulations. There was no significant difference (p < 0.05) within the cummulative drug release of optimized formulations. Modified starch and mucilage dispersion possessed excellent properties as excipient for ascorbic acid chewable tablet formulations using the direct compression method in view of its physicochemical and material properties as well as its positive panel assessment and stability over time
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