FORMULATION AND DEVELOPMENT OF FAST DISINTEGRATING FILM OF DONEPEZIL HYDROCHLORIDE USING SALVIA HISPANICA MUCILAGE AS SUPERDISINTEGRANT

Natural gums and mucilage have attracted considerable interest as multifunctional pharmaceutical excipients owing to their biocompatibility, biodegradability, and cost-effectiveness. The current study scrutinized the potential of Salvia hispanica (chia) seed mucilage as a natural superdisintegrant in the formulation of oral fast dissolving films (ODFs) of Donepezil hydrochloride. Salvia hispanica (Chia) seed mucilage was isolated and characterized for its physicochemical properties. Different quantities of chia seed mucilage were used in the solvent casting procedure to create donepezil hydrochloride-loaded ODFs (F1–F6). Appearance, weight variation, thickness, folding durability, surface pH, moisture loss, drug content, in vitro disintegration time, and in vitro dissolution were all assessed for the formulations. FTIR was used to evaluate drug-excipient compatibility, while scanning electron microscopy (SEM) was used to study surface shape. For two months, the optimized formulation was put through accelerated stability tests in accordance with ICH requirements (40 ± 2°C/75 ± 5% RH). Drug–excipient compatibility was confirmed by IR spectroscopy and the drug did not undergo any changes in the crystal structure. SEM images showed rough, flaky and plate-like surface morphology. All formulations complied with as per acceptable Pharmacopeial limits, the drug content ranges from 94.2–99.2%. The thickness of the film was in the range of 50.33 to 60.41 μm and moisture loss ranged from 4.1 to 4.8%. The mucilage concentration was observed and the disintegrating time was found to be in the range from 42.1 to 59.5 s. Of all the formulations, the formulation F3 showed the shortest disintegration time (42.1 ± 1.14 s) and the highest cumulative drug release (99.72% within 6 min). The stability studies revealed no significant changes in the physicochemical properties, drug content, Dissolution time and disintegration time. Salvia hispanica (Chia) seed mucilage was a promising natural superdisintegrant for the Development of Donepezil hydrochloride oral disintegrating films. The optimized formulation (F3) showed rapid disintegration, good drug release and satisfactory stability, which indicated its ability to act as a viable immediate-release oral drug delivery system to better serve patients compliance.