University of Khartoum

Efficiency of four Experimental Designs for development of Colon-targeted Matrix Formulation

Efficiency of four Experimental Designs for development of Colon-targeted Matrix Formulation

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Title: Efficiency of four Experimental Designs for development of Colon-targeted Matrix Formulation
Author: Omer, Hadeel Hassan Salih
Abstract: Background: As one of aims of pharmaceutical development is to design a quality product and a manufacturing process in a reproducible manner, the use of statistical experimental designs and optimization techniques nowadays found wide-spread use. As no single design suites development and optimization of all pharmaceutical products, searching for the efficiency of different designs on a pharmaceutical product is important. Objectives: In this study 23 full factorial, 2(3-1) fractional factorial, mixe0d levels quantis and two-level taguchi designswere comparatively investigated for their appropriateness and efficiency in developing and optimizing colon-targeted matrix formulation of Ibuprofen, a model drug. Method: Factors iterated within all designs included guar gum content, tablet hardness and drying temperature of granules prior compression whereas responses measured for comparison were precolonic % drug release as indicated by matrix dissolution efficiency during the first 5hours (DE0-5hrs) and colonic % drug release (DE7-26hrs). Results: While 23 full factorial and 2(3-1) fractionaldesigns have similarly supported the use of 10% guar gum to form granules that dried at 40oC prior compression into tablets of hardness level of 10kg/cm2 in order to achieve very limited precolonic drug release (DE0-5hr ≤ 5), both models indicated the use of 10% guar gum to form granules that dried at 60oC prior compression into tablets of hardness level of 5kg/cm2 as to attain maximum colonic drug release (DE7-26hrs ≥ 85). Value of DE0-5hr revealed by the mixed-level three factors quantis design was under estimated. Moreover, the model supported the compression of tablets to a wider range of hardness (5-10 kg/cm2) indicating the insignificancy of the compression force role in the drug release process, which goes up against the documented role of hardness on matrix drug release. Furthermore, the expected value of DE7-26hr revealed by the quantis model (95.3%) was higher compared to the other three models whichopposeboth the high gel strength behavior of the guar gum and the nature of the matrix systems. 23 full factorial, 2(3-1) fractional and mixed levels quantis designs have addressed slight, but effective, increase in DE0-5hr and DE7-26hr with increasing the drying temperature. However, this was not the case with the taguchi design in which increasing and decreasing values of DE0-5hr and DE7-26hr were revealed, respectively. Conclusion: Among the four designs tested in this study, both full and fractional designs confirmed to be more effective compared to quantis and taguchi designs in estimating optimum guar gum content, granules drying temperature and tablet compression force to develop colonic target matrix system based on desired drug release parameters.
URI: http://khartoumspace.uofk.edu/handle/123456789/19967
Date: 2016-03-23


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