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 |
↵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 (12).