Pharmaceutical Packaging Flashcards
1
Q
How is packaging crucial to medicines?
A
Contains - Presents
Protects - Preserves
Identifies - Informs
Advertises - Prevents counterfeiting
Prevents adulteration - Ensures compliance Ensures - convenience Enables delivery
2
Q
How many levels of packaging are there?
A
primary - actual white case that tablets are in
secondary - the box the tablets come in
tertiary - big box containing several packs of tablets
3
Q
More details on the primary packaging?
A
- Primary pack is in direct contact with the
medicine so there must be no compatibility
issues - Numerous different materials employed
- aluminium -plastic - aluminium + rubber glass - plastics + aluminium foil
- can be either multi pack or single unit
4
Q
More details on secondary packaging?
A
- Secondary packs contain the primary pack
and various ancillary components
– Patient information leaflet (PIL)
– Delivery aid, e.g. spoon, spatula (paste/ointment), applicator
(pessary) - The secondary pack typically consists
of thick paper known as paperboard - Plastics are sometimes used, particularly
with fragile primary packs, e.g. glass vials/
ampoules - Principal purpose is protection against mechanical damage
to a medicine, but also protects against other factors, e.g.
light
5
Q
Packaging and product stability?
A
- Primary pack must be compatible with the
drug + excipients present - It must also maintain the integrity of the dosage form
- Packaging materials must be selected with the stability of a
specific product in mind
Packaging and product stability
6
Q
common packaging materials: glass… why is it used?
A
- 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 - Different types of glass are available, and they
vary in their degree of inertness - Fragile and heavy but can be moulded into
different shapes - It is widely recycled
- Glass used in medicines packaging is covered in
the British Pharmacopoeia Appendix XIX B. Glass
Containers for Pharmaceutical Uses
Glass
Amber glass filters out
the most damaging
wavelength light
7
Q
What types of glass are used in packaging?
A
- 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 - Appendix XIX B. Glass Containers for Pharmaceutical Use
– Test A. Hydrolytic resistance of the inner surfaces of glass containers
(surface test); acid-base titration
– Bottles filled with water, autoclaved, and then titrated against 0.01M
HCl with methyl red as the indicator
8
Q
Why are plastics used in packaging?
A
- Plastics are polymers used extensively in
packaging - Plastics have a variety of different properties: they can be
strong/breakable, rigid/flexible, clear/opaque,
thermoplastic/thermosetting - Whether amorphous or crystalline can impact properties
- Amorphous polymers, e.g. polyvinyl chloride (PVC)
– Can have good transparency (plastic tablet bottle)
– Often “plasticized” to make it more flexible (iv infusion bags)
– Some permeability to water and organic vapour - Crystalline / semi-crystalline polymers, e.g. polyvinylidene
chloride (PVDC)
– Tough and stiff / good heat resistance
– Chemically inert
9
Q
What are the advantages of combining plastics?
A
- 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
10
Q
What polymer plastics are used in packaging?
A
- 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
11
Q
Why are metals used in packaging?
A
- Metal brings numerous advantages
– Mechanical strong / shatterproof (but can be
flexible/malleable)
– Able to withstand heat
– Impermeable to light, liquids and vapours - But metals can be expensive, heavy and interact with the
medicine (coating with plastics can prevent this) - Aluminium
– Impermeable to moisture, oxygen/ other gases, microbes
– Inhalers, collapsible tubes
– Foils used in blister packs - Tinplate
– Steel coated with tin
– Often used in closure manufacture
12
Q
Why are paper, paperboard + cardboard used in packaging?
A
- Inexpensive and sustainable / recyclable
- Mostly consists of the polymer cellulose
- Paper and paperboard (paper >250 g/m2
or > 300 m 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
13
Q
What are some examples of approaches + technology to make packaging better + more sustainable?
A
- Examples of approaches and technology:
– Paperboard from sustainably-managed forests or
recycled material
– Plastics from post-consumer recycled (PCR)
materials
– Polyethylene (PE) from sugarcane makes up 50%
of blister packaging in one new product
– Aluminium oxide incorporated into PE can impart
barrier properties equivalent to aluminium foil
laminates – also is recyclable
