Physicochemical Characterization of Plectranthus Edulis (Ethiopian Potato) Starch and its Evaluation as a Disintegrant In Paracetamol Tablet Formulations

dc.contributor.advisorGebre-Mariam, Tsige(Professor)
dc.contributor.advisorBelete, Anteneh (PhD)
dc.contributor.authorAssefa, Anteneh
dc.date.accessioned2018-06-13T12:13:06Z
dc.date.accessioned2023-11-06T08:09:04Z
dc.date.available2018-06-13T12:13:06Z
dc.date.available2023-11-06T08:09:04Z
dc.date.issued2015-01
dc.description.abstractPlectranthus edulis, Vatke (P. edulis) [fam., Lamiaceae], is an ancient Ethiopian tuber crop and one of the traditional root crops indigenous to Ethiopia. It is a large (~1m high) and an erect herbaceous plant with hirsute, decumbent and glandular stems, and leaves of lanceolate to elliptic and root of swollen nodes which produces edible underground potato-like tubers. Starch from the tubers of P. edulis was isolated using 0.075% (w/v) sodium metabisulphite and it gave a yield of about 80.4% on dry weight basis. The starch was examined for the chemical composition, amylose content, physicochemical properties and evaluated for its applicability as a pharmaceutical disintegrant in tablet formulations. The proximate composition of the starch on dry weight basis was found to be 0.14% ash, 0.21% lipid, 0.43% protein, and 99.22% starch. The amylose content was 30.6%. Its true density, moisture content and pH values were 1.47 g/ml, 11.2% and 6.6, respectively. Scanning electron microscopy (SEM) of the starch granules showed characteristic morphology that was oblong (elliptical) with some oval in shapes. The starch showed a monomodal normal granule size distribution with a mean particle size of 36.2 μm and specific surface area of 0.302 m2/g. The DSC thermograms of P. edulis starch exhibited higher T0 (69.2 oC), Tp (74.3 oC) and Te (83.3 oC) values than potato starch. X-Ray Diffraction pattern of the starch was typical B-type with a distinctive maximum peak at 17.5o 2θ. The FTIR spectral features of the starches show characteristic peaks at 3325, 2930, 1462, 1377, 1155, 860 cm-1 attributed to various stretching and bending vibrations of O–H, C–H, C–O, or C–O–C bonds for starches. It has typical swelling power, solubility and moisture sorption pattern at different conditions of temp and relative humidities. It possesses higher values relative to potato starch, but its solubility values are lower than potato starch at all temp studied. The comparative disintegrant abilities of these starches in paracetamol tablet formulations prepared by wet granulation method were studied. The granules prepared with the starches (P. edulis starch and potato starch) at different disintegrant concentrations were characterized for particle size distribution and flow properties. The excellent flow property of the granules was manifested by the weight uniformity of tablets. The crushing strength, friability, disintegration time, and dissolution rate of the tablets were studied using standard methods. The results II indicated that the properties of paracetamol tablets formulated with both starches as disintegrants were affected by their concentration and the compression force (CF). Increasing the concentration of the starches reduced the crushing strength and disintegration time of the tablets and increased the percent friability of the tablets. Conversely, increasing the CF increased crushing strength and disintegration time of the tablets and reduced the percent friability of tablets. The results have shown that P. edulis starch has favorably competed with potato starch as a disintegrant in the paracetamol tablet formulations. The optimization study of P. edulis starch as a disintegrant in paracetamol tablets was carried out by selecting the CF (X1) and P. edulis starch concentration (X2) as factors, and crushing strength, percent friability and disintegration time as response variables; and employing central composite statistical design (CCD). Design-Expert 8.0.7.1 software was utilized in the experimental design, statistical analysis and optimization process. Using the software several statistical parameters were compared, quadratic model for all the three responses were selected, and the adequacy of the models were checked by analysis of variance (ANOVA). The ANOVA results revealed that quadratic model is significant for the terms (factors) and responses studied. A quadratic mathematical model was developed; and the optimum formulation of paracetamol tablet containing P. edulis starch as a disintegrant was obtained by simultaneous optimization of the responses. From the optimum region, a CF (X1) of 14.40 KN and a disintegrant concentration (X2) of 5.96% was selected to check the validity and predictability of the design. The predicted values of crushing strength, friability and disintegration time of the formulation at the aforementioned levels of factors closely matched with the results of actual experimentation. Thus, the optimization technique provided the optimum formulation of paracetamol tablet containing P. edulis starch as a disintegrant. The results of the physicochemical characterization of P. edulis starch, as well as the comparative and optimization study of the starch as a disintegrant in the tablet formulations indicate that P. edulis can be used as an alternative source of starch for applications in the pharmaceutical industry. Keywords: Plectranthus edulis, Starch, Differential scanning calorimetry, Scanning electron microscopy, X-ray diffraction, Tablet disintegrant, Optimization, Central Composite Designen_US
dc.identifier.urihttp://etd.aau.edu.et/handle/123456789/765
dc.language.isoenen_US
dc.publisherAddis Ababa Universityen_US
dc.subjectPlectranthus edulis;Starch; Differential scanning calorimetry; Scanning electron microscopy; X-ray diffraction Tablet disintegrant;Optimization; Central Composite Designen_US
dc.titlePhysicochemical Characterization of Plectranthus Edulis (Ethiopian Potato) Starch and its Evaluation as a Disintegrant In Paracetamol Tablet Formulationsen_US
dc.typeThesisen_US

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