pharmaceutics - packaging Flashcards
who approves packaging info for UK medicines?
MHRA
reasons to package medicines?
presentation
identification
protection
information
what is primary packaging?
in direct contact with medicine
must not interact with the medicine
protect medicine from damage and contamination
what is secondary packaging?
additional packaging materials that dont make direct contact with the medicine
types of primary packaging?
- single and multi-dose containers
- strip packs
- blister packs
- glass
what must primary packaging offer?
child-resistance to restrict access
tamper-resistance and tamper evidence
what is a closure?
device part of the pack
provides effective seal to retain contents and exclude contaminants
why aren’t plastics safe like people think?
- known permeability to water vapour, oxygen and other small molecules
- plastics contain low-molecular weight additives that can be released over time
advantages of glass packaging?
inert/compatible with most drugs
stable at high temps
clear to allow visualisation
can be coloured to protect from UV
disadvantages of glass packaging?
costly
heavy
brittle
certain types release alkali into content
what is type 1 glass?
borosilicate glass
highest pharmaceutical grade
most inert and high hydrolytic resistance
high thermal resistance
suitable for all preparations but expensive
what is type 2 glass?
soda-lime-silica glass
treated with sulphur dioxide
mostly used for aqueous preparations
what is type 3 glass?
similar to type 2 but more leachable oxides
commonly used to produce dispensary medical bottles
advantages of plastic packaging?
light and shatterproof
easily shaped and sealed
cheap
greater versatility
disadvantages of plastic packaging?
inertness and impermeability is lower
less resistant to heat and long-term exposure of light
