PACKAGING DEFINITIONS…………Basic information
- The primary container is the immediate container in direct contact with the pharmaceutical product. This container typically protects the drug from the environment (e.g., gas, moisture, and light) and plays the greatest role in regulating the conditions to which the drug is exposed.
- Enclosing the primary container is a secondary container. This container may contain one or more primary containers and typically provides protections and labeling for the primary container.
- Some drugs require light protection based on their stability characteristics, and these drugs should be packaged in light-resistant containers.
- Many drugs are moisture-sensitive, so their storage requirements may dictate that a tight container Well-closed, tight, and hermetic containers also are assigned
Packaging systems are also classified based on the dosage capacity of the container.
- A single-unit container is one that contains a single quantity of medication to be used at one time, whereas a single-dose container is a single-unit container designed for parenteral administration only.
- A unit-dose container is also a single-unit container, but notably the unit-dose container does not include parenteral preparations and is mainly intended for solid oral dosage forms.
- The unit-of-use container is one that may contain any number of doses, but is designed to be dispensed as packaged without further repackaging and is intended for a specific therapeutic use.
- In containers holding multiple drug doses, a multiple-unit container is one that encloses multiple doses and permits multiple withdrawals of oral dosage forms, while a multiple-dose container is a multiple unit containers.