UNIT 4 - PACKAGING OF MEDICINES Flashcards
aka container-closure system
Packaging System
This includes Primary packaging components as well as Secondary packaging components when such components are requires to provide additional protection.
Packaging System
A receptacle that holds an intermediate compound, API, excipient, or dosage form, and is
in direct contact with the article
Container
(e.g., ampules, vials, bottles, syringes, and pen injectors)
Container
A material that seals an otherwise open space of a Container and provides protection for the contents. It also provides access to the contents of the Container.
Closure
(e.g., screw caps and stoppers).
Closure
the act of removing a drug product from the original manufacturer’s packaging system
and placing it into another, usually of smaller size
Repackaging
For dispensing liquids of low
viscosity
Prescription bottles
For bulk powders and viscous liquids
Wide mouth bottle
For ophthalmic, nasal,
otic, or oral liquid
administered by drop
Dropper bottle
Used for applying liquid
medication to a wound or
skin surface
Applicator bottle
For semisolid DF such as ointments
and creams
Ointment Jar & Collapsible Tube
Single-unit containers for solid DFs
like tablets, capsules & lozenges
Blister and Foil Packs
For topical powders to be applied
by sprinkling. Bottle sprays are for
applying liquid medication in mist
Sifter-top Container & Spray Bottle
Used for dispensing suppositories
and powders prepared in packets
Slide or Hinge-lid Boxes
For small and large volume
parenterals and admixtures
Ampules, Vials, IVF Bags
By law, dispensing containers must restrict entrance of moisture into the container.
Moisture
has deteriorating effect on many dosage forms, especially capsules, tablets, and powders.
Moisture
are hydrolyzed in the presence of moisture and broken down into acetic acid
and salicylic acid. Hydrolysis is the chemical reaction or process in which a molecule is split into two different species on reaction with water.
Aspirin tablets
tablets are always dispensed in their original glass bottles to minimize
exposure to air and moisture.
Sublingual nitroglycerin
Oxygen is one of the most common environmental factors to cause degradation.
Pharmaceutical packaging can use many different approaches to block or eliminate
oxygen or the free radicals it produces and provide the product protection needed.
Oxidation
Ultraviolet light is the most energetic form of light and is present in sunlight. Visible light is less energetic but can still provide the energy necessary for a chemical reaction to take place.
Light
ican also generate heat, or can be absorbed selectively by materials in the formulated product.
Light
such as hydrocortisone, prednisolone, and methyprednisolone are examples of drugs that are susceptible to changes from light.
Steriods
Sterility and prevention of microbial contamination of the packaging system
is of great concern when compounding sterile preparations like parenterals or ophthalmic preparations.
Package sterilization in aseptic systems uses two different mechanisms to achieve sterility of the
package and the package closure before being filled.
Microbial contamination
