Film-Forming Gels (FFG) is a primarily water–based, pH–sensitive polymer-containing mucoadhesive that forms a thin, dry film when applied topically. FFG adheres to skin or wet mucosal surfaces, creating a barrier, which lasts from minutes to days depending upon application site. This bioerodible film is non–irritating, dry, non–oily, and non–sticky. Importantly, all FFG ingredients are GRAS, readily available, and monograph compliant.
FFG can be utilized to deliver small molecules, peptides, proteins, and nucleic acids either locally to act at the site of administration or for the absorption of said molecules of interest across biological membranes into the systemic circulation.
FFG were evaluated in a GLP animal irritation study (buccal route) and were shown to be non–irritating in humans (in a non-GLP study). FFG were formulated to deliver a proprietary antimicrobial agent for vaginal application in a viral challenge in vivo mouse model; and were formulated to deliver a novel anti-inflammatory drug (used in the treatment of chronic mucocutaneous disorder) in a Phase II human clinical study.