W10 Pharmaceutical packaging

Question 1

Why is packaging critical to a medicine?

Answer 1

Contains
Presents
Protects
Preserves
Identifies
Informs
Advertises
Prevents counterfeiting
Prevents adulteration Ensures compliance
Ensures convenience Enables delivery

Question 2

How many packets in a tablet box?

Answer 2

3
Primary pack-cont tablets
Secondary pack- Outer packaging
Tertiary pack- Box containing all small boxes

Question 3

Why is the primary pack material important?
What materials are used in the primary pack?

Answer 3

• 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)

Question 4

2 types of primary packs:
Give examples

Answer 4

Multiple-unit pack: Calpol, Tablets Pot, Inhaler, Injection Vial, Cream
Single-unit pack: Blister packs, Plaster

Question 5

What do secondary packs contain? (2)

Answer 5

Secondary packs contain
- The primary pack
- Patient information leaflet (PIL)
- Delivery aid, e.g. spoon, spatula (paste/ointment), applicator (pessary)

Question 6

What does the secondary pack typically consist
of?

What is their principle purpose?

Answer 6

• 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

Question 7

Primary pack must be compatible with

Answer 7

-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

Question 8

Glass as a packaging material:
- What does it consist of?
- Benefit?
- Features

Answer 8

• 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

Question 9

Amber glass filters out the..?

Answer 9

Amber glass filters out the most damaging wavelength light

Question 10

Two main types of glass used in pharmaceutical packaging:

Answer 10

– 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

Question 11

Plastics as a packaging material:

What are the properties of plastics?
What do these properties depend on?

Answer 11

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

Question 12

Give an example of an Amorphous polymers:

Answer 12

Polyvinylidene chloride (PVDC)

Question 13

Explain properties of amorphous polymers (3)

Answer 13

– Can have good transparency (plastic tablet bottle)
– Often “plasticized” to make it more flexible (iv infusion bags)
– Some permeability to water and organic vapour

Question 14

Explain properties of Crystalline / semi-crystalline polymers:

Answer 14

– Tough and stiff / good heat resistance
– Chemically inert

Question 15

Example of Crystalline / semi-crystalline polymers:

Answer 15

polyvinylidene chloride (PVDC)

Question 16

Combining amorphous and crystalline polymers can bring together the advantages of both types:

Answer 16

• 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

Question 17

Combining amorphous and crystalline polymers can bring together the advantages of both types:

Answer 17

• 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

Question 18

Polyvinyl chloride (PVC)

Answer 18

– Very widely used but there are environmental
concerns around plasticizer use

Question 19

Polypropylene (PP)

Answer 19

– Good heat resistance: can be autoclaved at 121 °C
– Can be used when rigidity required

Question 20

High-density polyethylene (HDPE)

Answer 20

– Not impermeable to vapours
– Good heat resistance: can be autoclaved at 121 °C

Question 21

Polyethylene terephthalate (PET)

Answer 21

– Less permeable to oxygen than HDPE
– Parabens absorption has caused concerns

Question 22

Advantages of Metal as packaging: (3)

Answer 22

– Mechanical strong / shatterproof (but can be flexible/malleable)
– Able to withstand heat
– Impermeable to light, liquids and vapours

Question 23

Disadvantages of Metal as packaging:

Answer 23

Metals can be expensive, heavy and interact with the medicine (coating with plastics can prevent this)

Question 24

Aluminium as packaging:

Answer 24

– Impermeable to moisture, oxygen/ other gases, microbes
– Inhalers, collapsible tubes
– Foils used in blister packs

Question 25

Tinplate as packaging

Answer 25

– Steel coated with tin
– Often used in closure manufacture

Question 26

Paper and cardboard as packaging:
Benefits:
What does it consist of?
What packaging are they used in?

Answer 26

• 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