Pharmaceuticals for Oral Mucosal Drug Delivery: Regulatory Considerations

Abstract

Intraoral drug delivery offers many advantages including ease of accessibility, enhanced permeability, avoidance of first-pass metabolism, improved patient acceptability, and increased systemic absorption. Consequently, the oral cavity has become a very attractive and feasible site for local and systemic drug delivery. Despite industry interests, effective drug delivery through the oral mucosa is complex, and only a few products have achieved commercial success. Over the past few years, oral mucosal drug delivery research has greatly advanced with the advent of new technologies, mucoadhesives, and permeability enhancers. As a result, they also present new opportunities to increase the number of available therapeutics administered through the oral mucosa. Alongside the scientific hurdles, which are often unpredictable, a good understanding of the regulatory requirements for product development is critical for maximizing resources and positive interactions with the regulatory authorities. This chapter provides a general overview of the US Food and Drug Administration’s regulatory considerations for intraoral drug product development and marketing approval. A successful navigation through the regulatory approval process requires an interdisciplinary approach from the legal, clinical, chemistry, clinical pharmacology, nonclinical, and biopharmaceutics perspectives.