Umang Kumar, Shilpa Mamgain, Dr. Tarun Parashar
Background: Orodispersible films (ODFs), also referred to as oral thin films (OTFs), are rapidly dissolvingpolymeric films designed to release drugs in the oral cavity without the need for water, providing an innovativealternative to conventional oral dosage forms for patients who experience problems swallowing tablets or capsules. They are especially beneficial for pediatric, geriatric, and dysphagic populations, offering enhanced convenienceand compliance over traditional formulations. ODFs have been increasingly recognized in modern pharmaceutics asa patient-centric drug delivery system capable of rapid onset of action and enhanced bioavailability due to reducedfirst-pass metabolism. Advantages: Key advantages of ODFs include rapid disintegration within seconds, improved bioavailability, elimination of the need for water, enhanced patient compliance, and accurate dosing in portable formats. Their versatility also allows the delivery of both systemic and local therapies across various therapeutic areas. Formulation Components & Manufacturing Methods: ODFs are typically composed of film-forming polymerssuch as hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol (PVA), and natural polymers like maltodextrin, along with plasticizers, sweeteners, flavoring agents, saliva stimulating agents, surfactants, and stabilizers. Commonmanufacturing techniques include solvent casting, hot melt extrusion, semisolid casting, and rolling, while emergingmethods such as 3D printing and electrospinning offer personalized dosing capabilities. Evaluation & Regulatory Aspects: Quality assessment of ODFs involves mechanical testing, disintegration time, dissolution, drug content uniformity, moisture uptake, and bioavailability studies. Regulatory frameworks bytheFDA, EMA, and pharmacopoeial guidelines ensure the consistent quality, safety, and efficacy of these films. Challenges & Future Scope: Despite their advantages, ODFs face challenges including limited drug loadingcapacity, stability concerns, taste masking difficulties, and the need for specialized packaging. Future prospectsfocus on high-dose ODF formulations, smart biodegradable films, personalized medicine, regulatory harmonization, and innovations in industrial scale-up and manufacturing technologies.