Oral Thin Film Technology - Current Challenges and Future Scope

Abstract

Over the past few years, Oral Thin Films (OTFs) have intrigued scientists and researchers in the domain of pharmaceutical formulations and are being looked upon as a novel approach to designing efficient drug delivery systems. OTFs are currently speculated to be an alternative to the conventional solid and liquid oral dosage forms. Oral Thin Films are dissolving films or oral drug strips to administer drugs via their adsorption in the mouth, ensuring that the drug directly enters systemic circulation. The thin films enable the drug to bypass the first pass metabolism, have quick action, are more convenient for pediatric and geriatric patients where problems of swallowing or nausea are generally encountered, are easy to transport and package and have many such advantages over traditional dosage forms. However, the commercialization of these OTFs has been limited majorly to the American, Japanese and European Union markets only for a restricted number drugs. There is extensive research going on to enable different types of drugs to be formulated into these strips and to overcome certain challenges confronted during manufacture, scale up and the cost effectiveness of the OTFs. The presented review focuses primarily on the different manufacturing processes adopted for making the OTFs like Solvent Extraction, Hot Melt Extrusion, Semi-Solid Casting, Solid Dispersion Extrusion and innovative ones like Flexographic Printing Technologies and the technical and economic difficulties that manufacturers encounter during their large scale production. It also describes the current trends in the OTFs market and its future scope worldwide and in India and analyses the feasibility of this innovative approach in terms of the current knowledge and technological resources available.

Keywords: Oral Thin Films (OTFs), drug delivery, extrusion, first pass metabolism