Innovations in oral thin films: from formulation science to clinicalapplications

Doi: https://doi.org/10.55522/ijti.v3i5.0124

Abstract

Oral thin films (OTFs), sometimes called fast-dissolving films, have emerged as an innovative, alternative dosage delivery system intended to resolve the drawbacks of traditional oral dosage forms such as tablets or capsules. OTFs are defined as very thin (less than 50 µm), flexible polymeric strips containing an active pharmaceutical ingredient (API), by the United States Food and Drug Administration, and display rapid disintegration without the need for water, dissolved in the oral cavity, enhancing patient compliance in particular populations, including children, geriatrics, and dysphagic patients. Other advantages OTFs offer patients include predictable, swift onset of action; first-pass metabolism avoidance; bioavailability increases and patient convenience, while limitations include drug-loading capacity, fragility, and hygroscopicity. OTFs' formulation components are summarised with specific details on polymers, plasticisers, surfactants, sweeteners and flavouring agents; and OTFs manufacturing processes, including solvent casting, hot-melt extrusion, electrospinning, and printing technologies. Novel OTFs, including SOLULEAVES™, FOAMBURST™, and XGEL™, helps expanded OTF's many possible uses. Product evaluation parameters (e.g., drug content uniformity, disintegration time, tensile strength, stability) help ensure product quality and effectiveness. They are commercially marketed for seizure management, migraine relief, smoking cessation, vaccine delivery, and promising applications for probiotics, herbal therapy, and individual medicine. Overall, it represents a novel platform with enormous therapeutic potential for patients and significant opportunities for development in the future.