University of Khartoum

Effects of Applied Compression Force, Mixing Duration and Manufacturing Method on the Properties of Ibuprofen Sustained Release Matrices

Effects of Applied Compression Force, Mixing Duration and Manufacturing Method on the Properties of Ibuprofen Sustained Release Matrices

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Title: Effects of Applied Compression Force, Mixing Duration and Manufacturing Method on the Properties of Ibuprofen Sustained Release Matrices
Author: Elamin, Khaled Mohamed
Abstract: Hydroxy propyl methyl cellulose (HPMC) matrices are the most frequently used solid dosage in drug sustained release technology. Many formulation and processing variables are expected to influence the in vitro and, consequently, the in vivo performance of these matrices. This study aims to investigate the possible effects that mixing time, manufacturing method and applied compression force might have on the physicochemical properties of HPMC based Ibuprofen matrices. Methods: To achieve the stated objectives, 23 full screening and 32 optimizing designs were selected and applied in a consecutive manner. At the screening stage, mixing time, manufacturing method and applied compression force were explored, each at two levels, for their influences on weight, content, thickness, friability and drug release profile of different matrix formulations. Within the optimization stage, most influential factors found in the screening design (manufacturing method and applied compression force) were verified and optimized further, each at three levels, for their individual and mutual impact on matrix friability and drug release properties. Results: Based on the effect estimates of factors in the screening design, the influences of applied compression force on different matrix properties were quite apparent (p values for the effects on all properties measured ranged between 0.0017-0.0556, CI 95%) in contrast to that of mixing duration whereas the influence of manufacturing method was ambiguous. Upon optimization, however, both manufacturing method and applied compression force were confirmed to have profound improving effects (t' test, p≤ 0.05 for properties measured) on matrix friability (≤0.5%), thickness (≤ 4.4mm), drug dissolution efficiency (DE4hrs ≤0.2) and diffusional exponent of the drug release (0.5≤ n ≤1). Conclusion: The study concluded that both manufacturing method and applied compression force are important factors to be considered in development and optimization of an oral matrix tablet formulation. Application of either direct or slugging manufacturing methods and compression force equivalent to 6-8 kg/cm2 were essential to achieve matrix tablets with acceptable physical Ibuprofen release characteristics, at least under the adopted study conditions. The study recommends the collaboration between academia and local drug manufacturing facilities to enable the know-how transfer between different parties.
URI: http://khartoumspace.uofk.edu/123456789/16803
Date: 2015-10-29


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