Topical, Ophthalmic, and Otic Preparations

Included in this broad category are ointments, creams, lotions, pastes, gels, solutions, and nonmetered aerosols for application to the skin. 

Topical preparations should be evaluated for appearance, clarity, color, homogeneity, odor, pH, resuspendabil-ity (for lotions), consistency, viscosity, particle size distribution (for suspensions, when feasible), assay, degradation products, preservative and antioxidant content (if present), microbial limits and sterility, and weight loss (when appropriate). 

Appropriate stability data should be provided for products supplied in closed-end tubes to support the maximum anticipated use period—during patient use—once the tube seal is punctured, allowing product contact with the cap and cap liner. Ointments, pastes, gels, and creams in large containers, including tubes, should be assayed by sampling at the surface, top, middle, and bottom of the container. In addition, tubes should be sampled near the crimp (see also Section VII.D.2). 

Evaluation of ophthalmic or otic products (e.g., creams, ointments, solutions, and suspensions) should include the following additional attributes sterility, particulate matter, and extractables. 

Evaluation of nonmetered topical aerosols should include appearance, assay, degradation products, pressure, weight loss, net weight dispensed, delivery rate, microbial limits, spray pattern, water content, and particle size distribution (for suspensions). 

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Topical, Ophthalmic, and Otic Preparations Clarity, homogeneity, pH, resus-pendability (for lotions), consistency, viscosity, microbial bioburden, and water loss should be tested. For ophthalmic and otic products additional attributes should include sterility, particulate matter, and extractables. 

Tablets Capsules Emulsions Oral solutions and suspensions Metered dose inhalers Topical ophthalmic and otic preparations Parenterals...

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