Physicochemical Characterization Of Plectranthus Edulis (ethiopian Potato) Starch And Its Evaluation As A Disintegrant In Paracetamol Tablet Formulations

Plectranthus edulis, Vatke (P. edulis) [fam., Lamiaceae], is an ancient Ethiopian tuber crop andrnone of the traditional root crops indigenous to Ethiopia. It is a large (~1m high) and an erectrnherbaceous plant with hirsute, decumbent and glandular stems, and leaves of lanceolate tornelliptic and root of swollen nodes which produces edible underground potato-like tubers.rnStarch from the tubers of P. edulis was isolated using 0.075% (w/v) sodium metabisulphite and itrngave a yield of about 80.4% on dry weight basis. The starch was examined for the chemicalrncomposition, amylose content, physicochemical properties and evaluated for its applicability as arnpharmaceutical disintegrant in tablet formulations.rnThe proximate composition of the starch on dry weight basis was found to be 0.14% ash, 0.21%rnlipid, 0.43% protein, and 99.22% starch. The amylose content was 30.6%. Its true density,rnmoisture content and pH values were 1.47 g/ml, 11.2% and 6.6, respectively. Scanning electronrnmicroscopy (SEM) of the starch granules showed characteristic morphology that was oblongrn(elliptical) with some oval in shapes. The starch showed a monomodal normal granule sizerndistribution with a mean particle size of 36.2 μm and specific surface area of 0.302 m2/g. ThernDSC thermograms of P. edulis starch exhibited higher T0 (69.2 oC), Tp (74.3 oC) and Te (83.3 oC)rnvalues than potato starch. X-Ray Diffraction pattern of the starch was typical B-type with arndistinctive maximum peak at 17.5o 2θ. The FTIR spectral features of the starches showrncharacteristic peaks at 3325, 2930, 1462, 1377, 1155, 860 cm-1 attributed to various stretchingrnand bending vibrations of O–H, C–H, C–O, or C–O–C bonds for starches. It has typical swellingrnpower, solubility and moisture sorption pattern at different conditions of temp and relativernhumidities. It possesses higher values relative to potato starch, but its solubility values are lowerrnthan potato starch at all temp studied.rnThe comparative disintegrant abilities of these starches in paracetamol tablet formulationsrnprepared by wet granulation method were studied. The granules prepared with the starches (P.rnedulis starch and potato starch) at different disintegrant concentrations were characterized forrnparticle size distribution and flow properties. The excellent flow property of the granules wasrnmanifested by the weight uniformity of tablets. The crushing strength, friability, disintegrationrntime, and dissolution rate of the tablets were studied using standard methods. The resultsrnIIrnindicated that the properties of paracetamol tablets formulated with both starches as disintegrantsrnwere affected by their concentration and the compression force (CF). Increasing thernconcentration of the starches reduced the crushing strength and disintegration time of the tabletsrnand increased the percent friability of the tablets. Conversely, increasing the CF increasedrncrushing strength and disintegration time of the tablets and reduced the percent friability ofrntablets. The results have shown that P. edulis starch has favorably competed with potato starch asrna disintegrant in the paracetamol tablet formulations.rnThe optimization study of P. edulis starch as a disintegrant in paracetamol tablets was carried outrnby selecting the CF (X1) and P. edulis starch concentration (X2) as factors, and crushing strength,rnpercent friability and disintegration time as response variables; and employing central compositernstatistical design (CCD). Design-Expert 8.0.7.1 software was utilized in the experimental design,rnstatistical analysis and optimization process. Using the software several statistical parametersrnwere compared, quadratic model for all the three responses were selected, and the adequacy ofrnthe models were checked by analysis of variance (ANOVA). The ANOVA results revealed thatrnquadratic model is significant for the terms (factors) and responses studied. A quadraticrnmathematical model was developed; and the optimum formulation of paracetamol tabletrncontaining P. edulis starch as a disintegrant was obtained by simultaneous optimization of thernresponses. From the optimum region, a CF (X1) of 14.40 KN and a disintegrant concentrationrn(X2) of 5.96% was selected to check the validity and predictability of the design. The predictedrnvalues of crushing strength, friability and disintegration time of the formulation at thernaforementioned levels of factors closely matched with the results of actual experimentation.rnThus, the optimization technique provided the optimum formulation of paracetamol tabletrncontaining P. edulis starch as a disintegrant.rnThe results of the physicochemical characterization of P. edulis starch, as well as therncomparative and optimization study of the starch as a disintegrant in the tablet formulationsrnindicate that P. edulis can be used as an alternative source of starch for applications in thernpharmaceutical industry.rnKeywords: Plectranthus edulis, Starch, Differential scanning calorimetry, Scanning electronrnmicroscopy, X-ray diffraction, Tablet disintegrant, Optimization, Central Composite Design

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