Ultrathin oral films with extracts of Agastache mexicana and its hypnotic activity as a potential treatment for insomnia

Abstract

Ultrathin oral films are novel delivery systems that do not require water to swallow, show rapid systemic release, and allow a comfortable and precise dosage. These films represent an option for administering active metabolites from medicinal plants used against insomnia, such as Agastache mexicana. However, incorporating complex bioactive molecules can compromise the functionality of the films. This study evaluated the physicochemical properties and biological activity of sodium alginate films added with the ethanolic extracts of Agastache Mexicana. After incorporating the extracts, the films preserved their homogeneous morphology, thickness (<50 µm), and solubility time (<10 min). In contrast, hardness increased more than 40%, and elasticity increased 60%. Infrared spectroscopy analysis revealed that, after the preparation of the films, the functional groups of the extracts and the chemical structure of the ultrathin films were maintained. Moreover, we demonstrated that the hypnotic effect of Agastache mexicana was preserved, since the sleep onset latency and total sleep time in a murine model were similar between the liquid extract and the film formulation. These data support the use of ultrathin films with natural extracts as a potential treatment for sleep disorders like insomnia.