Examples of Packaging Concerns for Common Classes of Drug Productsb
| 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 |
↵Notes: 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 (14).