Formulación, elaboración y control de calidad de un suero oral a base de agua de mar

Abstract

The main objective of this research study was to focus on dehydration which is a serious public health problem that affects millions of people, its origin is mainly due to ADD together with other causes such as physical exercise and burns, therefore, the objective was to develop a product in the form of an oral serum based on seawater with suitable excipients that meets the sanitary requirements as an efficient and safe alternative in the treatment of dehydration. The methodology implemented had a quantitative approach, experimental design, exploratory level; the research was based on the search for information from Pharmacopoeias and scientific articles where the quality control of seawater began, including the determination of pH, density, elemental impurities, ions and microorganisms. In the quality control of the finished product, the microbiological quality was evaluated according to USP # 42 specifications. Through this methodology it was determined that the seawater has a pH 7.78, a density of 1. 023 g/mL, compliance with the elemental impurities of USP # 42 was demonstrated, the quantity of ions present was quantified and the microbiological analysis of the finished product was favorable since it met the criteria established by USP # 42. 4 formulations were prepared and the optimum one was determined according to the adequate organoleptic characteristics of the final product. Finally, the necessary volume of seawater was defined, which was 166.67 mL, and the dilution percentage to be used in the serum formulation was 33.33%, which does not exceed the maximum intake limits established by FDA, EFSA and NIH. In this context, seawater satisfies the requirements for human consumption and the finished product becomes a safe alternative for electrolyte replacement in patients with dehydration.