ABSTRACT
Acid hydrolyzed starch produces microcrystalline starch (MCS) with improved functional properties in terms of flowability or compressibility. The aim of this study was to investigate the binder, disintegrant and compressional properties of native and modified starches derived form of Digitaria iburua. Digitaria iburua grains were collected and identified by the herbarium unit of Department of Biological Sciences, Ahmadu Bello University, Zaria. Digitaria iburua starch (DS) was extracted from the grains using the wet method of extraction and the percentage yield was determined. Microcrystalline starch (MCS) was produced by acid hydrolysis using 6 N HCl. The amylose-amylopectin content of DS and MCS was determined. The physicochemical characterization for DS and MCS was conducted using standard methods. Metronidazole granules of varying binder and disintegrant concentrations (2.5, 5.0, 7.5, 10.0 and 12.5 % w/v) were prepared by wet granulation method of massing and screening and compared with Maize Starch BP (MS) and gelatin (GEL) as standard disintegrant and binder respectively. The granules were subjected to tests to determine its flowability and compressibility. The granules were then compressed into tablets at 7.0 metric tones after mixing with extra granular excipients. Quality control tests were conducted on the tablets after compression of the granules. The mode of fragmentation or deformation of the powder was assessed by Heckel analysis. Digitaria iburua grains yielded 62.88 % w/w DS and after 24 h of hydrolysis, the yield of MCS was found to be 85.14 % w/w. The amylose-amylopectin ratio for MCS determined revealed that the amylose content at different hydrolyzing times was greater than the amylopectin content. The mean particle size was found to be less than 10.5 µm for both starches. The values of angle of repose, Carr`s index and Hausner`s ratio for viii DS and MCS suggest that the materials possess poor flow property. The particle size distributions of the granules were uniformly distributed. Tablet parameters revealed that the crushing strength (CS) increased with increase in the binder concentration for all binder types while CS decreased with increase in disintegrant concentration for disintegrant types. The CS of the binder type is in the order; GEL>MCS>DS while that of the disintegrant is; MCS>MS>DS. The friability (FR) decreased with increase in binder concentration for all binder types while showing an increase with increase in disintegrant concentrations. The disintegration time (DT) increased with increase in binder concentration while increase in disintegrant concentration resulted in a decrease in DT. The (CS/FR)/DT values of the tablets decreased with increase in disintegrant concentration for all disintegrant type. Maize starch B.P. has the highest (CS/FR)/DT ratio at all concentrations. The (CS/FR)/DT ratio for tablets containing DS and MCS was comparable. The dissolution efficiency (D.E.) which is the percentage of drug released after 30 min ranged from 85.48 – 99.03 % for 7.5 % w/v binder concentration and 96.49 – 100 % for 10.0 % w/w disintegrant concentration. The order of D.E for 7.5 % w/v binder concentration was; DS>MCS>GEL while the order of D.E for 10.0 % w/w disintegrant concentration was; DS>MS>MCS. The mean yield pressure (PY), relative density at zero pressure (DO) and total deformation occurring in the powder (DA) ranked in this order: GEL>MCS>DS. The fragmentation tendency of the powder (DB) value was in the order: MCS>GEL>DS. The mean yield pressure was high which is indicative of higher resistance against plastic deformation. The (CS/FR)/DT and compressional studies results revealed that tablets were generally weak. DS and MCS could be used with other excipients to produce tablets that require fast disintegration
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