Produção e caracterização de filmes de desintegração oral à base de agar-agar com adição de extrato hidroalcóolico das sementes de Hibiscus sabdariffa L.

Abstract

Orally disintegrating films (ODFs) emerge as an alternative to other pharmaceutical forms, characterized by rapid disintegration, thus allowing for the release of active agents directly into the oral mucosa. Roselle (Hibiscus sabdariffa L.) is a plant cultivated primarily for its flowers, leaves, calyces, and seeds. Roselle seeds are found within the calyx after the flower wilts. They are small and dark in color, rich in proteins, fibers, lipids, and minerals. Additionally, roselle seeds contain bioactive compounds, antioxidant properties, and nutritional benefits. In this context, the objective of this study was to develop agar-based orally disintegrating films incorporating hydroalcoholic extract of Hibiscus sabdariffa L. seeds (HEHSS) as a source of phenolic compounds. Four formulations were tested, varying HEHSS concentrations (0, 1, 3, and 5 g HEHSS/100 g of film-forming solution) with constant sorbitol (30 g/100 g polymer) and agar-agar (3 g/100 g of film-forming solution) concentrations. After production, the ODFs were characterized regarding visual evaluation, mass, thickness, water content, color parameters, surface pH, contact angle, contact angle kinetics, disintegration time, scanning electron microscopy, atomic force microscopy, and total phenolic compounds. Regardless of formulation, the orally disintegrating films demonstrated film formation capability, ease of handling, and ease of removal from the production support. Mass and thickness showed no significant differences across HEHSS concentrations. Water content ranged between 11.57-14.85 g/100 g film. Regarding color parameters, increasing HEHSS concentration in the ODFs led to a significant increase in b* chroma values due to increased yellow coloration. Surface pH remained near 6.9 regardless of HEHSS concentration or evaluation time. Addition of different HEHSS concentrations reduced disintegration time from ~89.00 seconds (0 g HEHSS) to ~70.78 seconds (5 g HEHSS) and increased phenolic compound concentration (p<0.05), indicating effective incorporation of the extract in the film and minimal degradation of compounds during drying. Therefore, orally disintegrating films can be considered an innovative vehicle for active compounds, with no reported mucosal irritation during consumption.