Dissolvable oral thin films (OTFs) evolved over the past few years from the confection and oral care markets in the form of breath strips and became a novel and widely accepted form by consumers for delivering vitamins and personal care products. Companies with experience in the formulation of polymer coatings containing active pharmaceutical ingredients (APIs) for transdermal drug delivery capitalized on the opportunity to transition this technology to OTF formats. Today, OTFs are a proven and accepted technology for the systemic delivery of APIs for over-the-counter (OTC) medications and are in the early- to mid-development stages for prescription drugs.
This article provides insight into the functionality and benefits of dissolvable films and reviews the current product landscape and market potential. The authors also explain how thin films are formulated and manufactured, and discuss potential future applications.Functionality and benefits
Pharmaceutical companies and consumers alike have embraced OTFs as a practical and accepted alternative to traditional OTC medicine forms such as liquids, tablets, and capsules. OTFs offer fast, accurate dosing in a safe, efficacious format that is convenient and portable, without the need for water or measuring devices (2). OTFs are typically the size of a postage stamp and disintegrate on a patient's tongue in a matter of seconds for the rapid release of one or more APIs.
The formulation of dissolvable films is customarily facilitated through aqueous polymer matrices that span a wide molecular weight (MW) range, thereby providing flexibility to achieve certain physical properties. With the selection of appropriate polymer excipients, these properties can be tailored to meet specific API-loading needs and dissolution rates.