W10 Pharmaceutical packaging Flashcards
Why is packaging critical to a medicine?
Contains
Presents
Protects
Preserves
Identifies
Informs
Advertises
Prevents counterfeiting
Prevents adulteration Ensures compliance
Ensures convenience Enables delivery
How many packets in a tablet box?
3
Primary pack-cont tablets
Secondary pack- Outer packaging
Tertiary pack- Box containing all small boxes
Why is the primary pack material important?
What materials are used in the primary pack?
- Primary pack is in direct contact with the medicine so there must be no compatibility issues
Aluminium (inhaler)
Plastic (Calpol bottle)
Aluminium + Rubber glass (VIAL)
Plastics (IV bag)
Plastics + aluminium foil (blister packs)
2 types of primary packs:
Give examples
Multiple-unit pack: Calpol, Tablets Pot, Inhaler, Injection Vial, Cream
Single-unit pack: Blister packs, Plaster
What do secondary packs contain? (2)
Secondary packs contain
- The primary pack
- Patient information leaflet (PIL)
- Delivery aid, e.g. spoon, spatula (paste/ointment), applicator (pessary)
What does the secondary pack typically consist
of?
What is their principle purpose?
- Thick paper known as paperboard
- Plastics are sometimes used, particularly
with fragile primary packs, e.g. glass vials/
ampoules
-Protect against mechanical damage to a medicine, but also protects against other factors, e.g. light
Primary pack must be compatible with
-All components of the medicine (drug + excipients)
- It must also maintain the integrity of the dosage form
-Packaging materials must be selected with the stability of a specific product in mind
Glass as a packaging material:
- What does it consist of?
- Benefit?
- Features
- Consisting of a silica (silicon dioxide; SiO2) in a 3D
network, glass is generally not referred to as being polymeric - It possesses excellent barrier properties against
all substances - Fragile and heavy but can be moulded into different shapes
- It is widely recycled
Amber glass filters out the..?
Amber glass filters out the most damaging wavelength light
Two main types of glass used in pharmaceutical packaging:
– Neutral glass (Type I) is a borosilicate glass containing significant amounts of boric oxide, aluminium oxide alkali and/or alkaline earth
oxides
– Soda-lime-silica glass (Type II or III) is a silica glass containing alkali metal oxides, mainly sodium oxide and alkaline earth oxides, mainly calcium oxide.
- All types are resistant to heat and can be autoclaved (121 °C)
- Alkali components may leach from glass causing chemical
instability
Plastics as a packaging material:
What are the properties of plastics?
What do these properties depend on?
Plastics are polymers used extensively in packaging
They can be:
-strong/breakable,
-rigid/flexible,
-clear/opaque, thermoplastic/thermosetting
-Whether a plastic is amorphous or crystalline
Give an example of an Amorphous polymers:
Polyvinylidene chloride (PVDC)
Explain properties of amorphous polymers (3)
– Can have good transparency (plastic tablet bottle)
– Often “plasticized” to make it more flexible (iv infusion bags)
– Some permeability to water and organic vapour
Explain properties of Crystalline / semi-crystalline polymers:
– Tough and stiff / good heat resistance
– Chemically inert
Example of Crystalline / semi-crystalline polymers:
polyvinylidene chloride (PVDC)
Combining amorphous and crystalline polymers can bring together the advantages of both types:
- PVC / PVDC films
– PVC (amorphous) tough, low cost and easily coloured, but a poor
barrier
– PVDC (crystalline) provides protection against water vapour but is
expensive and can be brittle - Commonly used in blister pack manufacture + aluminium foil
Combining amorphous and crystalline polymers can bring together the advantages of both types:
- PVC / PVDC films
– PVC (amorphous) tough, low cost and easily coloured, but a poor
barrier
– PVDC (crystalline) provides protection against water vapour but is
expensive and can be brittle - Commonly used in blister pack manufacture + aluminium foil
Polyvinyl chloride (PVC)
– Very widely used but there are environmental
concerns around plasticizer use
Polypropylene (PP)
– Good heat resistance: can be autoclaved at 121 °C
– Can be used when rigidity required
High-density polyethylene (HDPE)
– Not impermeable to vapours
– Good heat resistance: can be autoclaved at 121 °C
Polyethylene terephthalate (PET)
– Less permeable to oxygen than HDPE
– Parabens absorption has caused concerns
Advantages of Metal as packaging: (3)
– Mechanical strong / shatterproof (but can be flexible/malleable)
– Able to withstand heat
– Impermeable to light, liquids and vapours
Disadvantages of Metal as packaging:
Metals can be expensive, heavy and interact with the medicine (coating with plastics can prevent this)
Aluminium as packaging:
– Impermeable to moisture, oxygen/ other gases, microbes
– Inhalers, collapsible tubes
– Foils used in blister packs
Tinplate as packaging
– Steel coated with tin
– Often used in closure manufacture
Paper and cardboard as packaging:
Benefits:
What does it consist of?
What packaging are they used in?
- Inexpensive and sustainable / recyclable
- Mostly consists of the polymer cellulose
-Paper and paperboard (paper >250 g/m2
or > 300 microm thickness) are primarily used
in secondary pack manufacture
Primary pack: paper was traditionally
used for wrapping powders and is still
used in sachet manufacture and packaging of effervescent
tablets
