Preparation and Characterization of Pregelatinized Enset Starch and Evaluation of its Use as Binder and Disintegrant in Tablet Formulations
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Date
2010-05
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Addis Ababa University
Abstract
Ensete ventricosum (Welw.) Cheeseman which belongs to the family Musaceae is a potential source of starch in Ethiopia. Starch is usually modified either chemically or physically to augment its convenience for industrial use. In this study, enset starch was modified by a physical method called pregelatinization. Properties of pregelatinized enset starch such as, densities, flow, swelling power, percentage solubility, moisture sorption, and compactability were investigated and compared to those of native enset starch and Starch 1500®. The comparative binding and disintegrant abilities of these starches in tablet formulations were also studied using paracetamol as a model drug. The granules prepared with the starches at different binder concentrations were characterized for particle size distribution, friability, and flow properties and the tablets were tested for crushing strength, friability, disintegration time, and dissolution rate using standard methods. The results indicated that pregelatinization improved the flowability of enset starch. Generally, the swelling power and percent solubility of the starches were found to increase with temperature and the values are higher for pregelatinized starches. The moisture sorption profiles indicate that the relative humidity during tablet production and storage should be carefully controlled. The compaction study revealed that the tensile strength of the compact of pregelatinized enset starch (10.14 Kg/cm2) and Starch 1500® (12.24 Kg/cm2) were comparable (p > 0.05). Compacts from native enset starch, however, presented significantly lower tensile strength (5.60 Kg/cm2). The results also indicate that granules and the tablets prepared with pregelatinized enset starch and Starch 1500® exhibit comparable characteristics. An increase in binder concentration provided tablets with increased crushing strength and disintegration time and decreased friability. The study also revealed that the softening of the tablets prepared with native starch as a disintegrant was reduced when prepared with pregelatinized starch. The dissolution studies of the paracetamol tablets showed that the release of the drug was within acceptable range (quantity dissolved in 30 min ≥ 80%). Thus, it can be concluded that pregelatinized enset starch can be a better binder and disintegrant than the native one in tablet formulations.
Key Words: Enset Starch; Pregelatinized Starch; Tablet; Binder; Disintegrant.
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Keywords
Enset Starch; Pregelatinized Starch; Tablet; Binder; Disintegrant