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Design of Experiments (DoE) is a statistical model that aims to determine if the factors under study affect the response, and if so, it determines the conditions under which this variable of interest can be optimized. In terms of pharmaceutical technology, independent variables are usually factors of the formulation, while dependent variables are properties of the product or parameters that indicate the performance of the process. Precisely, the dissolution test is a tool of interest for the developers of medicines since it allows them to evaluate the performance of a formulation designed in a solid pharmaceutical form, such as tablets. The present investigation used the design of experiments to establish and optimize the conditions of the dissolution test of a 10 mg Rupatadine fumarate tablets formulation, resulting in the use of HCl 0,1 N (pH 1) dissolution medium and a rotation speed of 100 rpm for the apparatus II USP, which allow the analysis of the product in a reproducible and reliable way. Keywords: Analysis of variances, Design of experiments, Dissolution test, Factorial design, Rupatadine Fumarate, Tablets, Test conditions.

It is essential to guarantee physico-chemical compatibility between the active pharmaceutical ingredient (API) and the components that are planned to be used in the development of a pharmaceutical formulation. A successful compatibility study allows distinguishing between the excipients that can be used and those that may represent a risk in the quality, safety and efficacy of the medication. The present study focuses on the identification of possible incompatibilities between Rupatadine fumarate and the excipients of three formulation prototypes for the development of API´s 10 mg tablets. Samples of each raw material, placebos and preformulation mixtures were analyzed by differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), X-ray diffraction (XDR) and infrared spectroscopy (IRS). The results obtained were analyzed and contrasted with the literature. Based on these, it is demonstrated that the excipients used along with the API do not generate problems in terms of compatibility, as there are no chemical changes in the drug.

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