INTRODUCTION

Mucosal drug products deliver drug substances to the body via the mucosal route. For the purposes of this chapter, the mucosal route of drug administration is divided into seven membrane surfaces characterized as otic, ophthalmic, nasal, oropharyngeal, urethral, vaginal, and rectal. Mucosal drug products include a wide variety of dosage forms such as solutions, suspensions, emulsions, creams, ointments, gels, inserts, strips, aerosols, sprays, films, medicated chewing gums, lozenges, tablets, and suppositories. Some of these dosage forms are also administered by other routes. For example, creams can be administered by the mucosal route (vaginal) and also by the topical route. Two categories of tests—product quality and product performance—are performed on these products. These tests provide assurances of batch-to-batch quality, reproducibility, reliability, and performance of a drug product. Product quality tests are performed to assess attributes such as assay, identification, and content uniformity and are part of the compendial monograph (see Mucosal Drug Products—Product Quality Tests 〈4〉). Product performance tests are conducted to assess the drug release from the dosage form. For certain mucosal drug products, determination of aerodynamic particle size or globule size may serve as a product performance test.