TABLE III

Examples of Packaging Concerns for Common Classes of Drug Productsb

Degree of Concern Associated with the Route of AdministrationLikelihood of Packaging Component-Dosage Form Interaction
HighMediumLow
HighestInhalation aerosols and solutions; injections and injectable suspensionsaSterile powders and powders for injection; inhalation powders
HighOphthalmic solutions and suspensions; transdermal ointments and patches; nasal aerosols and sprays
LowTopical solutions and suspensions; topical and lingual aerosols; oral solutions and suspensionsTopical powders; oral powdersOral 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).