Neuropsychophysiological measurements as tool for neuromodulator oral films evaluation

Oral films (OF) are a new delivery system of drugs or bioactive molecules for oral administration. Pharmaceutical and nutraceutical companies have been investing in the knowledge of these innovative products and technologies. Although there are multiple products on the market, in terms of regulatory guidelines, much uncertainty still exists about the appropriate methods, specifications, and standardization for the development and evaluation of OF. This paper systematically reviews the scientific literature about the use of psychophysiological approaches in neuromodulator OF evaluation. The PRISMA reporting criteria for systematic reviews and meta-analyses were applied, and 6 publications ranging from 1993 to 2020 were found suitable for inclusion in this study. These studies were analyzed to evaluate the contribution of psychophysiological measurements as a model of evaluation for neuromodulator OF. The combined data confirmed the lack of psychophysiological studies in the evaluation of OF, and raised the importance, as well as, advantages of using psychophysiological measurements as valuable evaluation methods. Moreover, it provides support for a more non-invasive, but detailed evaluation of these new drug/bioactive molecules delivery systems.