ABSTRACT

The oral fast-dissolving drug delivery systems were first developed in the late 1970s as an advanced alternative to conventional oral tablets and capsules for pediatric and geriatric patients who experience difficulties in swallowing traditional oral solid dosage forms [1]. In response to this need, oral thin films evolved from confectionary and fresh breath strips to become a novel and widely accepted film dosage form by consumers and patients for delivery of supplements, vitamins, and active pharmaceutical ingredients (APIs) [2-4]. Vaginal films containing nonoxynol-9 (N-9) have been marketed since 1995 for contraceptive use. In 2010, the first two oral film products, Zuplenz® (Strativa Pharmaceuticals, Woodcliff Lake, NJ, USA) and Suboxone® (Reckitt Benckiser Pharmaceuticals, Inc., Richmond, VA, USA), were approved by the US Food and Drug Administration (FDA) for use as an antiemetic for prevention of nausea and vomiting after chemotherapy and opioid dependence

treatment, respectively. To date, the film dosage form has been proposed for drug delivery to the buccal and vaginal mucosa as well as gingival, sublingual, and dermal surfaces [5-10].