Validação bioanalítica, análise farmacocinética e preparo de uma nanoemulsão do α-bisabolol

Abstract

Natural products are the greatest basis for the discovery and development of new drugs. Chamomile is an herb commonly used in the preparation of teas by different cultures and has several reported therapeutic effects. α-bisabolol (α-BIS), its main constituent, has been the target of several pharmacological studies due to its ability to act on different body systems, from inflammatory processes to pain. The behavior of the compound in the body has not yet been elucidated since there are no pharmacokinetic studies on them.. For pharmacokinetic analysis, a bioanalytical method is necessary so that it is possible to quantify plasma concentrations of the compound after administration. Furthermore, due to its physicochemical characteristics, the development of a nanoemulsion to improve its solubility in biological media becomes interesting. Therefore, the objective of this work was to develop and validate a bioanalytical method for the determination of α-BIS in plasma using High Performance Liquid Chromatography (HPLC) and subsequently evaluate its pharmacokinetics after intravenous administration of a nanoemulsified formulation containing the compound . To achieve this, the method was developed in accordance with the requirements recommended by regulatory agencies. The chromatographic conditions consisted of an isocratic flow of 1 ml/min of acetonitrile and ultrapure water (80:20), read at wavelengths of 201 and 240 nm.. The developed method proved to be precise, accurate, sensitive, and selective for quantifying the compound up to one month after freezing. The applicability of the method was carried out through a pharmacokinetic analysis of α-BIS after intravenous administration of the compound in Wistar rats, where pharmacokinetic parameters such as volume of distribution, clearance and half-life were calculated using concentration data. With this validated method and pharmacokinetic analysis carried out, it becomes possible to develop new in vivo studies that aim to quantify α-bisabolol in biological matrices, in addition to assisting in new pharmacodynamic studies, since, for the first time, the pharmacokinetics of the compound were described.