Multilayered mucoadhesive hydrogel films based on Ocimum basilicum seed mucilage/thiolated alginate/dopamine-modified hyaluronic acid and PDA coating for sublingual administration of nystatin

The present study establishes an experimental design for the preparation of new bi and tri-layer mucoadhesive sublingual films based on basil (Ocimum basilicum L.) seed mucilage (OBM) as novel plant-polysaccharide for oromucosal administration of nystatin (Nys). The films formulation consists of a drug reservoir-mucoadhesive layer cross-linked via CaCl2, with protective mucoadhesive layers based on thiolated alginate (TA) and poly dopamine (PDA). OBM served as a new mucoadhesive polysaccharide in second layers, where the dopaminemodified-hyaluronic acid (DHA) improved the mucoadhesive strength and swelling rate properties. The drug loaded formulations of trilayer film with PDA coating, and bilayer film with DHA/OBM (1:1) in the second layer, showed the desired mucoadhesion properties (about 69 and 75.3% respectively). The obtained results revealed that the bilayer film containing DHA had a superior swelling degree in the range of 15-19 (g/g). While the PDA coating sample showed the highest resistance to water uptake and erosion. The bilayer film (DHA/OBM with 1:1 ratio) provided a maximum drug release of 86% after 4 h. The selected formulations indicated good mechanical properties with no cytotoxicity.