DEPOFILMTM - A NOVEL AND EFFICIENT METHOD FOR PRODUCING ORAL SOLUBLE FILM FOR DRUG DELIVERY

Project Summary-Nova Thin Film Pharmaceuticals LLC NOVA Thin Film Pharmaceuticals’ (NTFP) mission is to unlock the full economic andamp; therapeutic potential of the orally soluble film (OSF) dosage form. OSF pharmaceutical products were first introduced in the early 2000s andamp; are particularly appropriate for certain therapeutic areas andamp; patient types. The ability to swallow an OSF easily without water combined its portability made it particularly apropos for pediatric patients as well as adults or geriatrics with dysphagia. In addition, OSF products have found very successful applications in systemic drug delivery by sublingual or buccal routes to avoid GI digestion, gut-wall metabolism and hepatic first-pass metabolism. The limitation to widespread use of OSF has always been the cost and waste associated with the traditional solution film-casting process used in their manufacture which also makes rapid formulation prototyping difficult. NTFP’s approach involves our patented film-by-deposit system (DepoFilm™), which offers dramatic efficiency and cost advantages over the existing standard manufacturing methodology. DepoFilm™ is an integrated process for film manufacturing andamp; packaging. The film former solution andamp; drug are deposited and dried in wells that are part of a web that comprises the final package of the product. At the end of the drying cycle, a heat-sealable aluminum laminate ‘lidding’ sheet is applied to complete primary packaging. Yield loss is limited to very minor handling loss – we expect yields in the range of 96-98% which could even be superior to some types of tablet and capsule manufacturing processes involving multiple unit operations. Nova will license DepoFilm technology and offer product development services to ethical pharmaceutical companies seeking to develop OSF formulations of 1) pediatric and/or adult formulations of their existing or pipeline drugs, 2) drugs requiring buccal or sublingual delivery to avoid GI tract or first-pass metabolism andamp; 3) other suitable drug candidates for which portability and non-requisite water intake are desired attributes e.g acute or rescue indications. NTFP would work with client companies to develop andamp; manufacture OSF formulations for approval using the 505(b)(1) or 505(b)(2) New Drug Application pathway. The elegance, simplicity andamp; cost-effectiveness of our approach will also unlock OSF product possibilities in the Consumer Health/OTC space that were previously economically unattractive. Our management team is composed of a group that essentially created the modern pharma OSF industry. Joseph andamp; Richard Fuisz helped start the thin film drug delivery sector, inventing the largest patent portfolio for pharmaceutical OSF by solution-casting andamp; co-founding MonoSolRx/Aquestive Therapeutics. Madhu Hariharan is a drug delivery expert who worked on thin film at MonoSol Rx, has several OSF patents, andamp; through his consulting company Solvekta, has worked on virtually every major pharma film product launch to date.Project Narrative – Nova Thin Film Pharmaceuticals LLC (NTFP) There is a major unmet need to deliver oral pediatric drugs in a patient-friendly manner that provides improved compliance while being portable, ‘non-spillable’, compact and stable. NTFP’s DepoFilm™ technology represents a disruptive advancement in Oral Soluble Film (OSF) by dramatically lowering the cost of development and manufacture of these dosage forms. The DepoFilm™ platform offers compelling value for ethical pharmaceutical companies because it enables rapid formulation prototyping, greatly reduced development time, and near cost-parity with tablets/capsules – it opens up the possibility of buccal, sublingual and intraoral formulations for Phase I clinical studies which can be cross-utilized for adult or pediatric patient populations.