A PHARMACEUTICAL FORMULATION DEVELOPMENT USING A EXPERIMENTAL MIXTURE DESIGN
Keywords:experimental design of mixtures, research and development, surface of response.
The principal aim of this paper is to apply the experimental design of mixtures to formulate a solid dosage form (ibuprofen) through the study of the excipients and their proportion in the formulation. Besides it shows to the research and development teams in the pharmaceutical national companies how they can use statistical tools like the experimental design of mixtures to obtain a product with the required characteristics. The optimization of this one reduces not only the costs of investigation but also the costs of production. The experimental design of mixtures allows to typify the performance of the ibuprofeno formulation from the pharmatechnic point of view, as well as the angle of rest, hardness of the nucleus and friability. Besides Carr’s’s index, characterizing a surface of response that allows an efficient utilization of this methodology for the resolution of the problem of formulation. The angle of rest shows that it is necessary to improve the fluency of the formulation to guarantee a correct filling of the counterfoils in the rattling process on an industrial scale. The parameters of hardness and friability show that the formulations are correct and that it is possible to continue with a process to optimize the formulation.
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