Análisis de los estudios de preformulación de una forma farmacéutica líquida a base de amoxicilina trihidratada.

Abstract

The preformulation is understood as a series of tests necessary to determine the physicochemical and biopharmaceutical nature of an active principle, for which these characteristics are studied, identifying whether it qualifies for a formulation. For this reason, the objective is to analyze the preformulation studies on a liquid pharmaceutical form based on amoxicillin trihydrate, applying a bibliographic search to identify the first steps to follow for the design of a new drug. Through a scientific bibliographic search, considering a series of analyzes on amoxicillin trihydrate, taking into account solubility and particle characteristics; in addition to bioavailability, compatibility and stability studies. It was identified that amoxicillin has a good solubility in the digestive tract, due to its stability at certain temperatures and low pH, which makes it a good option to be administered orally. However, in aqueous mixtures the stability decreases considerably; despite the fact that it is compatible with several excipients such as flavorings, alcohols, etc., which do not produce a chemical alteration or degradation of the drug; For this reason, a powder formulation for solution is proposed, which once in solution can take on the properties of a liquid pharmaceutical form. As a conclusion, it was obtained that there is a large number of studies to be carried out for a good preformulation, in addition to suggesting that the most stable way to obtain a liquid pharmaceutical form for the studied drug is by reconstituting it, so that its stability is prioritized.