The objective of this study was to develop and assess orodispersible films as a solution to the limitations of traditional dosage forms, including deterioration caused by first liver metabolism, reduced effectiveness and lack of patient adherence. The current study involved the formulation of taste-masked lansoprazole in the form of an orodispersible film. The primary aim of this formulation was to develop an orally dissolving film of lansoprazole that effectively masks its taste, hence improving patient adherence across all age groups from adults to geriatrics. The orodispersible films were fabricated using the solvent casting technique, with pullulan serving as the film-forming agent, PEG-400 as the plasticiser, citric acid as the salivary stimulant, mannitol as the sweetening agent and mixed fruit flavour as the taste-masking agent. The preparation of lansoprazole film involved the creation of an inclusion complex with sulfobutyl-ether-β-cyclodextrin (SBEβCD) using the chilling process. The study utilized a 32 factorial design to examine the impact of two independent factors, namely the concentration of pullulan (X1) and the concentration of PEG-400 (X2), on three dependent variables: in-vitro drug release, folding endurance and disintegration time. The optimized formulation was assessed for its physical appearance, thickness, moisture content, weight uniformity, surface pH measurement and stability. The optimized batch (Y5) exhibited a drug release rate of 99.94%, a folding endurance of 72 and disintegration duration of 24 seconds. The proposed formulation was confirmed to display rapid drug release and stability using ex-vivo permeation, oral mucosa sensitivity testing, release kinetics and accelerated stability investigations. The combination of lansaprazole and Sulfobutyl-ether-β-Cyclodextrin, with its taste disguised, was effectively prepared into an orodispersible film.
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