Optimization of Dexketoprofen Trometamol Tablet Formulations Utilizing Different Modeling Techniques and the Quality by Design

Abstract

Dexketoprofen trometamol is a sensitive molecule and consists of a fine, poor flowing, extremely adhesive powder that leaves behind gummed residue on the punch surface of the tablet press machine. The purpose of this study is to determine the optimum formulation utilizing different modeling techniques and the Quality by Design (QbD) approach without sticking problem during production. General full factorial design of experiments (DoE) was formed and the raw experimental data were evaluated using Minitab, artificial neural network (ANN) and gene expression programming (GEP) modules of the INForm. The Minitab, ANN and GEP modeling programs suggested the optimum formulations that should contain 2.03% and 2.50% glyceryl dibehenate by applying slug compression. However, in trial studies, the only lubricant that resolves the sticking problem was sodium stearyl fumarate. Therefore, new optimum formula trials have been performed by employing sodium stearyl fumarate at the same percentages instead of glyceryl dibehenate. All of the optimum formula analysis indicates that quality target product profile (QTPP) was met and the sticking problem was resolved.