TABLE I

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 (1).