Rapid Delivery of Therapeutics Via Dissolution of Polymeric Films

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Oral delivery of pharmaceuticals is the most common form of drug administration, and is dominated by the use of tablets and capsules of various forms. However, there are a number of problems associated with tablets that diminish the utility of this form of dose administration. For instance, patients that have difficulty swallowing (children, the elderly, people with severe nausea, and patients suffering from dysphasia) are unable to tolerate solid tablets. In addition, tablets must pass through the gastrointestinal tract, with the therapeutic agents being absorbed through the gut. This takes significant amounts of time, delaying the onset of therapeutic action. Finally, drugs that are swallowed generally undergo metabolism, and can cause liver toxicity. As an alternative to tablets, thin polymer films that rapidly dissolve in the mouth have received significant attention. These films have been introduced in the market by Pfizer as Listerine PocketPaks, and have been a popular breath freshener since 2001. However, these films can also be loaded with pharmaceutical agents for oral drug delivery. This allows a therapeutic dose to be released in the mouth, and to be absorbed through the mucosal membranes directly into the bloodstream, bypassing the stomach and liver. This is advantageous as it results in rapid entry of drugs into circulation, bypasses gastrointestinal metabolism, decreases liver toxicity, and does not require swallowing. However, loading different drug compounds, especially those that are not water soluble, within a rapidly dissolving thin polymer film poses challenges, as different structures will impact film integrity and properties. This proposal aims to investigate new formulations for incorporation and encapsulation of a wide array of drugs within polymer films, and to help the industrial partner (Rapid Dose Therapeutics, Inc.) develop alternative delivery methods for the pharmaceutical industry.