Abstract
Ensete ventricosum (Welw.) cheeseman which belongs to the family of Musaceae is one of the main sources of starch in Ethiopia. This study aimed at evaluating epichlorohydrin cross-linked enset starch as a drug release sustaining excipient in microsphere formulations of theophylline. Extracted enset starch was cross-linked using epichlorohydrin as a cross-linking agent. The effect of cross-linker concentration, cross-linking duration, and cross-linking temperature on the degree of cross-linking and release rate of microspheres prepared by emulsion solvent evaporation method was investigated using the two-level full factorial design. Accordingly, the concentration of epichlorohydrin and duration of cross-linking were the most significant factors affecting both the degree of cross-linking and drug release rate. Thus, the effects of these two factors were further studied and optimized using the central composite design. As per the numerical method of central composite design, the optimal points were obtained at epichlorohydrin concentration of 13.70% and cross-linking time of 3.82 h. Under these optimal conditions, the model predicts the degree of cross-linking of 74.70% and drug release rate of 28.00 h1/2. The validity of these optimal points was confirmed experimentally. The microspheres of the optimum formulation also exhibited minimum burst release with sustained release for 12 h. Besides, the optimized formulation followed the Higuchi square root kinetic model with non-Fickian diffusion release mechanism. The finding of this study suggested that cross-linked enset starch can be used as an alternative drug-release-sustaining pharmaceutical excipient in microsphere formulation.
Highlights
IntroductionInexpensive, naturally renewable, and a major reserve polysaccharide of plant sources
Starch is an abundant, inexpensive, naturally renewable, and a major reserve polysaccharide of plant sources
The test result of Degree of Cross-Linking (DC) (Table 3) revealed that almost all the formulations showed discrepancies in their peak viscosity and the DC was observed to vary between the formulations
Summary
Inexpensive, naturally renewable, and a major reserve polysaccharide of plant sources. It is used as a source of energy during periods of dormancy and regrowth [1]. Of its wide applications in diverse areas of polymer science, starch has been used successfully as a polymer in the packaging industry and in the pharmaceutical manufacturing [2]. Different methods have been used to modify the functional characteristics of native starches in a way that can boost its pharmaceutical applications. Amongst the different techniques for starch modification, chemical and physical methods are the most common ones [1, 3]
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