Desenvolvimento de fitoterápicos a partir das folhas da nogueira-da-índia (Aleurites moluccanus): relato de experiência de parceria entre uma Universidade Comunitária e indústrias farmacêuticas nacionais

This work, of partnerships between a Community University and national pharmaceutical companies reports the development of new and effective phytotherapics obtained from the leaves of Aleurites mollucanus (Euphorbiaceae), an exotic species, from Asia, adapted in Brazil. The project, although it has not yet reached the final stage of clinical studies and registration with ANVISA, represents a relevant experience to be analyzed in light of the difficulties and overcomes during the stages that make up the chain of establishment of a new herbal medicine in Brazil. Tablets were developed based on the standardized dry extract of A. moluccanus, on pilot scale, with approval in the stages of non-clinical studies and in the clinical stage-phase I. In addition, formulations such as topical cream and oral suspension were established. The overcoming of challenges related to the standardization of the extract on an industrial scale, under good manufacturing practices (GMP) and the stability aspects of the formulations, the continuity of studies depends on the scenario and consequent market direction. Therefore, this report provides an insight into the setbacks and overcoming experienced by researchers from Brazilian Community University with a focus on research and development of new, effective and safe analgesic and anti-inflammatory herbal medicine.