PACKAGING OF MEDICINES Flashcards
(54 cards)
container-closure system. The sum of packaging components and materials that together contain and protect the article.
Packaging System
components when such components are requires to provide additional protection.
Secondary packaging
A receptacle that holds an intermediate compound, API, excipient, or dosage form, and is in direct contact with the article
Container
Container example
ampules,
vials,
bottles,
syringes,
pen injectors
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
Closure example
screw caps and stoppers
the act of removing a drug product from the original manufacturer’s packaging system
and placing it into another, usually of smaller size
Repackaging
PACKAGING CONSIDERATIONS
- Pre-formulation information on the drug substance
- The nature of the dosage form
- Drug product information
- Container material qualification
- Container/product compatibility
- Impact of the packaging operation on the drug product
- Ruggedness of the container system under actual conditions of packaging, shipping, storage and use
- Performance
- Cosmetic features
Pre-formulation information on the drug substance
sensitivity to heat,
oxygen,
humidity,
light,
glass,
metals,
pH,
reactivity with plastics, metals, or types of glass
The nature of the dosage form
solid oral,
liquids
powders,
creams,
ointments,
biodegradable polymers,
implants,
transdermals
Drug product information
humidity,
light,
heat,
pH,
compatibility studies w/ components
It should also be noted, further, that
drugs used or dispensed in __________need not be
dispensed with safety closures unless they are intended for patients who are leaving the confines of the institution.
inpatient institutions
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
PRODUCT INSTABILITIES WHEN PACKAGING
- Moisture
- Oxidation
- Light
- Microbial contamination
are hydrolyzed in the presence of moisture and broken down into acetic acid
and salicylic acid.
Aspirin tablets
is the chemical reaction or process in which a molecule is split into two different species on reaction with water.
Hydrolysis
