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.
In this article we 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.
Universal Tests
- Definition
- Identification
- Assay
- Impurities (organic, inorganic, and residual solvents)
- Uniformity of Dosage Units (typically included in a USP product monograph)
Specific Mucosal Route and Product-Specific Tests
Otic Route
- Sterility Tests (Typically required)
- Microbial Enumeration Tests (Where sterility is not required)
- Tests for Specified Microorganisms (Where sterility is not required)
- Antimicrobial Effectiveness Testing and Antimicrobial Agents—Content (Sometimes may required)
Ophthalmic route
- Universal Tests
- Particulate and Foreign Matter
- Sterility
- Particle Size and Particle Size Distribution
- Antimicrobial Preservative
- Viscosity
- pH
- Oropharyngeal route
- Minimum fill (for gels and ointments)
Urethral route
- Test for specified microorganism
- Microbial enumeration tests
Vaginal route
- Test for specified microorganism
- Microbial enumeration tests
- Minimum fill (for creams and gels)
Rectal route
- Softening time of lipophilic suppositories
- Minimum fill (for foams and ointments)
Reference: USP General Chapter 〈4〉
Read also: Product Quality Tests for Oral Dosage Form