Quality evaluation of a Brazilian marketed herbal medicine made from Schinus terebinthifolius Raddi: changes in the legislation for registration throughout 20 years / Avaliação da qualidade de um medicamento à base Schinus terebinthifolius Raddi (aroeira) comercializado no Brasil: adequação à legislação ao longo de 20 ano

Considering the importance of the evaluation of quality and performance attributes of herbal medicines, this work evaluated a gynecological gel containing aroeira (Schinus terebinthifolius Raddi), which was previously registered in 2001, and is still marketed in Brazil. Using the updated guides and legislation as a basis, the product was evaluated by checking the pH, spreadability, rheological behavior, in vitro release test, ex vivo permeation and retention study using porcine vaginal mucosa in Franz diffusion cells, and histological evaluation of the porcine vaginal mucosa before and after application of the product. After the permeation study, it was verified that gallic acid (chemical marker quantified) does not cross the mucosa, therefore, it is safe for local use. In addition, the pH of the formulation is within the range considered normal for use in healthy women. Finally, the histological evaluation of the mucosa showed changes compatible with the application of tannins (major compounds of the plant), and without changes indicative of loss of tissue integrity.

Mupirocin ointments: In vitro x In vivo bioequivalence evaluation

Bioequivalence (BE) assessment of topical drug products is a long-standing challenge. Agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published several drafts in recent years suggesting different approaches as alternative to evaluate the BE. A proposed Topical Classification System (TCS) has even been discussed. Given the above, the objective of this research was to use in vitro and in vivo BE approaches to evaluate Brazilian marketed mupirocin (MPC) ointments, previously classified as TCS class The in vitro permeation test (IVPT) was performed by applying formulations to pig skin by Franz cells. The in vivo methodology was dermatopharmacokinetic (DPK). These approaches (in vivo tape stripping and IVPT) demonstrated capability of distinguishing among different formulations, thus making them useful methodologies for BE evaluation