A container for a pharmacopoeial article is intended to contain a drug substance or drug product with which it is , or may be in direct contact. The closure is a part of the container (Indian Pharmacopoeia 2014).
Roles of containers
- Enable removal of contents in a manner suitable for intended use
- Provide adequate degree of protection from the environment
- Minimize loss of contents during storage, transport and use until the medicine is used
- Ensure integrity of the medicine
- Provide convenience and compliance for the medicinal product
- Provide identification of the medicinal product
Types of containers
Various pharmacopoeia including Indian Pharmacopoeia specifies different types of containers on the basis to their ability to protect their contents from external conditions and considerations for specific patients population categories (Child and elderly).
Well closed container protects the contents from contamination by extraneous solids and liquids and from loss of article under normal conditions of handling, storage and distribution.
Tightly-closed container protects the contents from contamination by extraneous solids, liquids or vapors, from loss or deterioration of article from effervescence, deliquescence or evaporation under normal conditions of handling, storage and distribution.
Airtight container is impermeable to solids, liquids and gases under ordinary conditions of handling, storage and transport.
Hermetically sealed container is impervious to air or any other gas under normal conditions of handling, storage and distribution.
(a) Single-dose container is intended for articles for parenteral administration and is designed to hold single dose (When opened cannot be resealed with assurance that sterility has been maintained).
(b) Multiple-dose container is a hermetic container that permits withdrawal of successive portions of the contents without changing the quality, strength or purity of remaining portion.
Tamper-evident container is fitted with a device or mechanism that reveals whether the container has been opened.
Light resistant container protects the contents from the effects of actinic light by means of opaque covering and/or stored in a dark place (USP standard: Not more than 10% transmission at any wavelength between 290-450 nm).
Child resistant container is one that is difficult for children under 5 years of age to open within a reasonable time and that is not difficult for normal adults to use properly.