Innovations in oral thin films: from formulation science to clinical applications

Priya Gogula, Haranath Chinthaginjala*, Nikhila Subramanyam, Bhargavi Dasari, Yaga Maheswar Reddy

Department of Pharmaceutics, Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Anantapur, Andhra Pradesh, India

Refer this article

Priya Gogula, Haranath Chinthaginjala, Nikhila Subramanyam, Bhargavi Dasari, Yaga Maheswar Reddy, Innovations in oral thin films: from formulation science to clinical applications. International Journal of Therapeutic Innovation, September-October 2025, V3 – I5, Pages - 6 – 11. 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 State 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 summarized with specific details on; polymers, plasticizers, 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 developments in the future.

Keywords:

Oral thin films, Mucoadhesive films, Bioavailability, Drug delivery system