Development evaluation and characterization of Buccal patches containing Nebivolo using hydrophilic polymers

Abstract

This study aimed to design and assess buccal patches for Nebivolo release, using mucoadhesive hydrophilic polymers such as sodium alginate and tamarind seed polysaccharide. The patches were constructed with a drug-free backing layer composed of 6% ethyl cellulose. The Nebivolo-loaded buccal patches were fabricated through the solvent evaporation technique, utilizing mucoadhesive hydrophilic polymers. The formulations were evaluated for various parameters, including patch thickness, weight variation, folding endurance, drug content, moisture content, moisture absorption, swelling percentage, surface pH, in vitro residence time, and mucoadhesive performance. Drug permeation studies were performed using a Franz diffusion cell with a goat buccal mucosal membrane in phosphate-buffered saline at pH 6.8. Characterization techniques such as FT-IR and SEM were employed to assess the formulation. Stability testing was carried out following ICH guidelines. The developed buccal patch formulations demonstrated consistent results in terms of average weight, thickness, drug content, moisture content, moisture absorption, swelling index, and surface pH. Among the seven formulations tested, F1exhibited the most favorable mucoadhesive strength (31.36±0.95 g), force of adhesion (0.31±0.04 N), highest swelling index (341±0.83%), and a residence time of over 24 hours. F1also showed the highest drug permeation rate (97.51%) over 24 hours and was stable. FT-IR analysis indicated no significant interaction between the drug and the polymer, and SEM analysis revealed a smooth surface texture of the patch. The formulated Nebivolo buccal patches hold significant potential for improving patient compliance and reducing the frequency of administration, offering a promising approach to controlled drug delivery.