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.

The views expressed in this chapter are those of the authors and do not reflect the official policy of the FDA. No official support or endorsement by the FDA is intended or should be inferred.