Aplicación del método SeDeM en la caracterización de sustancias pulverulentas para la preformulación y formulación de formas farmacéuticas por vía oral

Abstract

The following project studies the characterization of 50 pulverulent substances of pharmaceutical use. This was carried out using the SeDeM methodology. In addition, the Quality Management System of the Laboratory of Pharmaceutical Technology of the UTPL, through the generation of POEs, contributed to the different techniques used to perform the characterization of powdery substances. In the same way, a template was implemented with the database resulting from the characterization study. This showed what is the most suitable pharmaceutical form that an active principle needs, in addition to the correct selection of raw materials required by each Active principle and necessary manufacturing techniques that will help the active principle fulfill the purpose for which it was created. As a result, it was found that with the methodology employed it is possible to recognize the raw materials that can be used for the generation of solid dosage forms through direct compression and otherwise not suitable for another pharmaceutical form of oral administration