The mucosal route of drug administration is subdivided into seven membrane surfaces for the purposes of taxonomic distinction of dosage forms by route of administration. These membrane surfaces are characterized as otic, ophthalmic, nasal, oropharyngeal, urethral, vaginal, and rectal. This grouping does not include the pulmonary mucosal route addressed in Inhalation and Nasal Drug Products—General Information and Product Quality Tests 5. A drug product is administered to any of these seven mucosal surfaces to effect either local action or systemic absorption. Local action is to the area proximate to application. Where local action is intended, systemic absorption is not typically desired and is unnecessary for therapeutic effect. In some cases, however, the mucosal delivery of a drug for systemic absorption is used because it avoids first-pass metabolism, it provides more rapid systemic delivery, or it provides an alternative when oral delivery (to the gastrointestinal tract) is not possible due to a disease state. A large number of the dosage forms listed in Pharmaceutical Dosage Forms 11511 can be delivered by way of the various membrane surfaces in the mucosal category.

Analytical procedures and acceptance criteria for testing drug products are divided into two categories: those that assess general product quality attributes and those that assess product performance. Drug product quality tests assess attributes such as identification, assay (strength), dose content uniformity, and impurities and are usually part of the compendial monograph. Product performance tests include the dissolution test for a solid oral dosage form, Dissolution 711, and the drug release test, Drug Release 724. Taken together, quality and performance tests ensure the identity, strength, quality, and purity of a mucosal drug product.

This chapter also provides lists of consolidated, common product quality tests and certain specific tests based on route of drug administration requirements. Existing monographs contain all the tests required for the article. For new, specific drug product monographs or where a monograph is not available, the chapter provides specific quality tests as a resource for manufacturers until particular monographs for the specific product are developed by USP.

This chapter provides product quality tests that are generally necessary, tests that apply to specific products, and tests that apply to one or more of the specific mucosal routes. Quality tests listed under a specific mucosal route in this chapter represent expectations for any dosage form administered by that specific route.