Análisis bibliográfico sobre la compatibilidad química entre principios activos y excipientes en formulaciones sólidas orales

Abstract

Abstract: Chemical compatibility between active pharmaceutical ingredient and excipient is a factor underestimated in the development of solid oral formulations, and the mechanisms and chemical interactions reported for this system remain limited. In response to this gap, the present study aimed to develop a systematic bibliographic analysis of articles published between 2011 and 2025. The bibliographic analysis was carried out using the PRISMA 2020 method, with searches in databases such as Scopus, PubMed, ScienceDirect, and Web of Science, and the CEBM 2011 scale for methodological appraisal. The Maillard reaction was the most frequently reported mechanism, followed by hydrolysis and oxidation; furthermore, lactose and magnesium stearate were identified as the excipients with the highest recurrence among those involved in these active ingredient-excipient reactions. The most widely used characterization techniques are differential scanning calorimetry, infrared spectroscopy, and high-performance liquid chromatography, complementary techniques capable of confirming such incompatibility. The combined use of these techniques reduces the risk of false negatives and supports recommendations for pharmaceutical preformulation.