Solubility Enhancement and Formulation Development of an Oral Film of Ondansetron Hydrochloride Monohydrate using Mix-solvency Concept
Abstract
This research paper presents the formulation and evaluation of ondansetron hydrochloride monohydrate oral film using the mix-solvency concept. Ondansetron hydrochloride monohydrate a selective serotonin receptor antagonist is commonly prescribed to prevent chemotherapy or surgery-induced nausea and vomiting. The aim of the study was to enhance the solubility of ondansetron hydrochloride monohydrate which has been enhanced by the blend of varying aqueous solubilizers poly ethylene glycol, niacinamide, and caffeine. The oral film formulation was prepared using a solvent casting method, incorporating polymers, plasticizers and different solvents. Various formulation variables, including solvent type and concentration, polymer-to-plasticizer ratios, and drug loading, were optimized systematically the resulting oral film was investigated for various parameters such as thickness, drug content, disintegration time, folding endurance and surface pH. The % in-vitro release of drug of the best two formulations F3 and F5 was 99.70 and 96.62%, respectively.
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