primary packaging
- a packaging component that is or may be direct contact with the dosage form.
secondary packaging
-a packaging component that is not and will not be in direct contact with the dosage form
container closure
- the sum of packaging components that contain & protect the dosage form; can include primary & secondary packaging.
market package
-container closure system and labeling
- associated components like: dosing cups, droppers, spoons
glass containers
- is the traditional gold standard for pharmaceutical packaging.
a
Which type of glass is the highest quality and used for the MOST demanding applications?
a) Type I: Borosilicate
b) Type II: Treated Soda-Lime
c) Type III: Regular Soda-Lime
b
Which type of glass is suitable for most acidic and neutral aqueous products?
a) Type I: Borosilicate
b) Type II: Treated Soda-Lime
c) Type III: Regular Soda-Lime
c
Which type of glass is NOT used for parenteral products?
a) Type I: Borosilicate
b) Type II: Treated Soda-Lime
c) Type III: Regular Soda-Lime
a,b
Glass used for pharmaceutical containers is which type(s)?
a) Type I: Borosilicate
b) Type II: Treated Soda-Lime
c) Type III: Regular Soda-Lime
thermoplastics
-high molecular weight; amorphpous polymers with weak intermolecular bonds
thermosets
-polymers that cross-link and form irreversible bonds between polymer chains
-excellent chemical resistance & mechanical properties
permeation
-transmission of gasses, vapors, or liquids through plastic packaging; materials have an adverse effect on the drug
-oxidation, hydrolysis
leaching
-constituent from plastic container leaches into drug product causing toxic effect or catalyzes a reaction
sorption
-removal of constituents from the drug product by the package material; losses can affect efficacy and cause the loss of preservatives
chemical reactivity
-when ingredients in the drug product and the plastic formulation interact with one another
modification
-physical and/or chemical alteration of the packaging material by the drug product
a
Which plastic is the most widely used packaging material for drug products
a) high density polyethylene (HDPE)
b) low density polyethylene (LDPE)
c) Polyproylene
d) Polyvinyl chloride
b
Which plastic is the material of choice for liquid dispensing applications?
a) high density polyethylene (HDPE)
b) low density polyethylene (LDPE)
c) Polyproylene
d) Polyvinyl chloride
c
Which plastic is good for medical device applications?
a) high density polyethylene (HDPE)
b) low density polyethylene (LDPE)
c) Polyproylene
d) Polyvinyl chloride
closure
What is the most vulnerable & critical component of a container?
closure liners
-provide a gasket or seal to eliminate leaks by overcoming the minor imperfections between the container and closure
metal tube
-interior must be lined with wax-type formulation or resin solution to protect product from the metal
plastic tube
-LDPE, HDPE, or PP
-lined with other materials to improve barrier qualities
laminated
- consists of layers of plastic, paper, foil
functional packaging
-packaging that contains and delivers drug directly to the patient
-pre- filled syringes, injector systems, transdermal patches
overt tamper
-packaging system which must be cut or torn to open the container and remove the product
a
Which plastic has a poor barrier against gases?
a) high density polyethylene (HDPE)
b) low density polyethylene (LDPE)
c) Polyproylene
d) Polyvinyl chloride
a
What kind of plastic is Tyvek?
a) polyetylene
c) Polyproylene
d) Polyvinyl chloride
c
Which plastic is an effective barrier against gas, vapor, and moisture?
a) high density polyethylene (HDPE)
b) low density polyethylene (LDPE)
c) Polyproylene
d) Polyvinyl chloride
d
Which plastic is used for iv bags and tubing?
a) high density polyethylene (HDPE)
b) low density polyethylene (LDPE)
c) Polyproylene
d) Polyvinyl chloride
a
Which material is the most impermeable of the tube materials?
a) metal
b) plastic
c) laminated
b
Which blister packaging is the most protective?
a) polyvinyl chloride
b) aluminum
c) Aclar
d) Cycloolefine copolymer
a
Which blistering packaging is the cheapest to produce?
a) polyvinyl chloride
b) aluminum
c) Aclar
d) Cycloolefine copolymer
c
Which blistering packaging has the highest moisture barrier?
a) polyvinyl chloride
b) aluminum
c) Aclar
d) Cycloolefine copolymer
d
Which blistering packaging has outstanding transparency?
a) polyvinyl chloride
b) aluminum
c) Aclar
d) Cycloolefine copolymer