Degree of Concern Associated with the Route of Administration | Likelihood of Packaging Component-Dosage Form Interaction | ||
---|---|---|---|
High | Medium | Low | |
Highest | Inhalation Aerosols and Solutions; Injections and Injectable Suspensionsa | Sterile Powders and Powders for Injection; Inhalation Powders | |
High | Ophthalmic Solutions and Suspensions; Transdermal Ointments and Patches; Nasal Aerosols and Sprays | ||
Low | Topical Solutions and Suspensions; Topical and Lingual Aerosols; Oral Solutions and Suspensions | Topical Powders; Oral powders | Oral Tablets and Oral (Hard and Soft Gelatin) Capsules |
↵a For the purpose of this table, the term suspension is used to mean a mixture of two immiscible phases (e.g., solid in liquid or liquid in liquid). As such, it encompasses a wide variety of dosage forms such as creams, ointments, gels, and emulsions, as well as suspensions in the pharmaceutical sense.
↵b From Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics (1).