packaging

Question 1

how many stages ‘packs’ are there

Answer 1

3

Question 2

Pharmaceutical pack = stage 1

Answer 2

• includes container + closure; the closure is part of the pack
• closure happens by heat/pressure sealing

Question 3

closure

Answer 3

• Child-resistant, senior-friendly
• tamper-resistant (difficult to tamper with), tamper-evident (it will be obvious if someone has tampered with it)
• Cap material, liner, inner seal (often no liner)
• Closure is very important as it may allow exchange of gases if seal is not good.

Question 4

a pack can be single unit e.g a sachet or blisterpack
it can also be multiple unit e.g a bottle containing many tablets

Answer 4

single adv: you can see how many you have taken, each tablet is protected until you open it to take it
multdis: all tablets exposed to bacteria etc every time u open it

adv: more convenient to carry and easier to recycle

Question 5

unit dosages has what 2 types of packaging

Answer 5

blister and strip
https://www.notion.so/packaging-15300bb3982d806494dbfcec591cb91c?pvs=4#17b00bb3982d800d8901c8b657e379e3

Question 6

advantages of blister and strip packaging

Answer 6

convenient
patient education
compliance
tamper evident
stability

Question 7

packaging that can’t be separated from the medicine

Answer 7

asthma inhalers and patches go two in two

Question 8

why is compatibility of the primary pack key

Answer 8

The primary pack is in direct contact with the medicine. It must be compatible with the medicine, and must not change it in any way.
The pack must take nothing out of the product and add nothing in. e.g. how glass won’t get into your medicine

Question 9

why do we need packs for medicine?

The pack provides:

Answer 9

1. containment
2. protection
3. presentation
4. identification
5. information
6. convenience
7. compliance aids eg spoons

Question 10

example: packing covid vaccines:

Answer 10

consider vaccine stability to heat or storage

if not stable e.g. if sensitive to heat, and isn’t immediately put back in fridge etc, we cannot administer it, so must be thrown away, as no way to check

→ leads to lots of vaccine wastage
recently. vaccine vial’s have a sticker like vaccine vial monitor to check how long its been left out & how long? it changes colour to show thi

Question 11

role of packaging expanding

how?

Answer 11

?

• to combat counterfeiting e.g. scratching of a code to text to confirm if its fake or not
• To facilitate medicine administration by healthcare
  practitoners and by patients, e.g. use of pre-filled
  syringes, instead of drawing out from a multi dose bottle (ensures accurate dosing, however, even if using one vial, u need to use a new needle and syringe per patient due to contamination, and can lead to injuries)
• To brand and promote products to the consumer
• To remind patients to take their medicines and track
  their compliance

Question 12

packaging must:

Answer 12

• Be chemically inert, compatible with product
• Protect product from mechanical hazard, environmental hazard etc
• Be accessible to the user
• Be child-resistant, tamper-resistant, tamper evident
• Keep its integrity in the distribution system

Question 13

packaging materials:

Answer 13

Glass, plastics and metal - the most commonly used primary packaging materials.
Paper is used mainly in the secondary packaging. The latter holds/covers the primary pack. It can also be sashes
Rubber is used in closures
Laminates – consisting of plies (layers) of different materials such as paper, plastic and metal – combine the advantages of the different materials.

Question 14

glass advantages and disadvantages

Answer 14

advantages: relatively unreactive and inert, does not allow gas transmission, easy to clean, transparent, can be steam sterilised, etc)

disadvantage: fragility, heavy weight, (reduced by surface
coating and good design)

Question 15

glass characteristics

Answer 15

Consider type of glass, shape, volume, neck finishing,
colour, light transmission

Glass is composed mainly of silicon dioxide. Other oxides (which are loosely bound in the network) may also be present. There are different types of glass, some are more resistant than others. Need to consider application e.g. need for sterilisation

Question 16

what types of glass are there

Answer 16

type I, II and III

Question 17

Type I glass

Answer 17

also called borosilicate glass. the most inert, is highly resistant to temperature changes and the most expensive. It is used in ampoules and vials for liquid parenteral products, and to package slightly acidic solutions

Question 18

Type II glass

Answer 18

it’s surface is treated to reduce the amount of ions that can leach out of the glass. Type II glass is suitable for solutions that can be buffered to remain below pH 7.

Question 19

Type III glass – the next grade

Answer 19

– not used for aqueous parenteral preparations.

Question 20

plastic properties

Answer 20

→ widely used as diff types: e.g. bottles, tubes, pouches, blister packs, bags etc

use as a material growing due to their advantages and consumer preference
diff plastics/polymers = diff properties

Some have better barrier properties than others. Some are a good
barrier to water vapour but a poor barrier to oxygen.

plastics also may have residues of additives from making them

Question 21

plastic adv and disadvantages

Answer 21

advantages:

lighter than glass, resists breakage, lower cost. Flexible. Can be clear or opaque. Plastics are easily shaped and sealed, which gives great versatility in the design of the pack, and allows the inclusion of administration aids such as squeezable dropper

disadvantages:

permeable to water vapour, CO2, O2, allow light transmission, leaching of chemicals, poor impact resistance, not as clear as glass, many plastics often/melt if thermally sterilised. Disposal is an issue - usually of PVC, polystyrene etc

Question 22

diff types of bottles

Answer 22

check notion notes week 15
https://www.notion.so/packaging-15300bb3982d806494dbfcec591cb91c?pvs=4#17b00bb3982d808d8ff2fee2e493126c

Question 23

metals characteristics

Answer 23

usually aluminium and tinplate (a misnomer, a sheet of steel that is coated with a thin deposit of tin)

properties

Both soft and hard forms are used (e.g. hard for cans, soft for tubes).
Soft form can be crimped for sealing.

used in the form of cans, tubes, pouches, blister packs etc

Question 24

metal disadvantages and advantages

Answer 24

advantages

• mechanically strong
• can withstand the high internal pressure in aerosol containers
• shatterproof
• lightweight (due to the fact that it is strong even when thin layers are used)
• impermeable to gases and light
• malleable
• it can be tailored in hardness and flexibility with respect to the desired container

disadvantages

Metal can however interact with the pharmaceutical
product. To isolate the metal from the product, the metal surface is coated with plastic. The outside of the metal container is also coated to protect the metal and to enable printing.

Question 25

why collapsible metal tubes are good:

Answer 25

when squeezed to expel the product, e.g. a cream, the tube does not spring back into its original shape and air is not sucked back into the container, which could otherwise react with the product or cause it to dry out

Question 26

paper: characteristics

Answer 26

diverse applications, e.g. Labels, leaflets, collapsible and rigid cartons, bags, sacks, sachets. - not used in the manufacture of the primary pack, apart from sachets, but then the paper is separated from the product by a layer of plastic/metal defined as matted or felted sheet usually composed of natural plant fibre. When the paper material weighs 250 grams per square metre or more or is 300µm or more in thickness, it is known as paperboard

Question 27

paper disadvantages and advantages

Answer 27

advantages of paper: - relatively cheap, available, generally of non-toxic origin and easily recycled. - readily torn or cut open, an advantage when paper is used in sachets. - rigid and strong - allow its use in cartons. At the same time, it can act as a slight cushion and protect the primary pack. - Its deadfold (ability to hold a crease) allows the making of cartons and bags as well as its use for patient information leaflets. - It is easily printed and coated. - the nature and properties of the finished paper can be controlled, such that paper may be ‘tailor-made’ for specific applications. disadvantages: - has no barrier properties against moisture, gases, odours. - It is moisture-sensitive, has no heat or cold seal properties and hence cannot be sealed without adhesives or special coatings - Is not transparent or glossy

Question 28

how to overcome paper disadvantages

Answer 28

paper can be combined with other materials. For example, paper can be further coated by polymers, or laminated to plastic or to aluminium foil to improve its barrier properties to gases and moisture, and to create heat-sealing ability when used in the primary pack.

Question 29

laminates: xtra info

Answer 29

A laminate is made by bonding together two or more plies of different materials, such as paper, plastic and metal. The aim is to combine the desirable properties of the different plies into a single packaging structure. A minimum amount of material is used and the laminate is cost- effective. In sachets, blister packs, tubes, pouches, etc. E.g. a structure consisting of paper/foil/polythene plies, used for sachet packaging. The paper provides strength, printability and the ability to easily tear the package, the foil provides an excellent barrier to light, moisture and gases and the polythene enables heat sealability.

Question 30

xtra info on rubber e.g. how they aren't totally inert

Answer 30

Rubber (elastomer = a natural or synthetic polymer having elastic properties) is often used. Rubber closure is held by an aluminium cap. Natural or synthetic sources; rubber trees or derived from petrochemicals. Common pharmaceutical examples - butyl, chlorobutyl, natural and silicone elastomers. Like other plastics, rubbers are not totally inert. They are permeable to some extent, they may also absorb components of the packaged product and may leach residues and low- molecular weight components into the packaged contents

Question 31

packaging for product stability

Answer 31

- must be compatible with the product: take nothing out and add nothing in - sorption (absorption or adsorption) of the drug or other excipients such as preservatives, into the container would reduce product potency and stability, while chemicals leaching out of the container and into the product could induce drug degradation. - Solvent loss from a product can also occur if the container is permeable, which could result in drug and excipient precipitation. Pack must protect product against atmospheric factors eg * extremes of temperature * light * moisture * oxygen * carbon dioxide * particulates (e.g. dust, dirt) * biological hazards, such as microorganisms, insects and rodents

Question 32

why does a pack have to protect from all those factors

Answer 32

Heat can degrade a drug/ vaccine. Remember vaccine vial monitors?. Light can provide the energy necessary for a drug isomer to change its configuration. Oxygen can cause drug degradation via oxidation. Carbon dioxide can dissolve in the water in unbuffered aqueous products, and lower their pH by forming carbonic acid. Moisture can cause drug degradation via hydrolysis. Moisture gain into a product can also cause dilution of liquid products, wetting of solid products and an aqueous environment, which can support microbial growth.

Question 33

substances which remove hazards

Answer 33

Dessicants (e.g. silica gel, bentonite, calcium chloride, calcium oxide, molecular sieves, carbon) and oxygen absorbers (such as iron oxide, StabilOx) may be used.

Question 34

aside from desiccants and oxygen absorbers how else can we remove hazards

Answer 34

Some products e.g. PharmaKeep absorb both moisture and oxygen. * Absorbers are contained within sachets or canisters that are placed inside containers, or can be integrated within the container walls, for example, in Oxy-Guard barrier bottles or integrated within the container closures. * combo of an impermeable container and a moisture/oxygen absorber sachet may also be used, the impermeable container protecting against degradation that could arise from moisture/oxygen from the atmosphere ingressing into a container and the sachet absorbing any moisture/oxygen

Question 35

Secondary and tertiary packs also contribute to protection - how?

Answer 35

- against atmospheric factors to some extent e.g. light. However, their major role is to provide protection against mechanical hazards e.g. shock when dropped, compression, vibration, abrasion, puncture etc during handling, storage and transport.

Question 36

Original Pack Definition:

Answer 36

Designed for direct dispensing to the patient without changes, except for adding appropriate labels

Question 37

Repackaging in Pharmacy Settings:

Answer 37

- **Purpose:** Often required in hospitals or community pharmacies to transfer medicines into different packaging. - **Common Scenarios:** Typically involves tablets and capsules, but can include liquids like methadone.

Question 38

Key Considerations for Repackaging:

Answer 38

1. **Primary Container Selection:** - Ensure good containment and protection of the medication. - Verify compatibility between the product and the container material. 2. **Risk and Stability Factors:** - Assess potential for **errors** during repackaging. - Consider **physical and chemical stability** of the medicine. - Maintain **cleanliness** to avoid cross-contamination. - Evaluate the **shelf-life** of repackaged products. 3. **Legal and Labelling Requirements:** - Comply with legal standards and guidelines. - Provide clear and accurate labelling for safety and compliance.

Question 39

packaging and regulatory bodies

Answer 39

the pharmaceutical packaging is subject to regulation and approval by government agencies such as the United States Food and Drug Administration (FDA), and the UK’s Medicines and Healthcare products regulatory agency (MHRA). This is as it’s considered part of the product.

Question 40

why is packaging and safe medicine use so key

Answer 40

- as 1/4 of med errors due to similar med names or packaging good med naming practice includes: Actions that would result in clearer and safer packaging, such as global standardisation of the packaging, have been recommended by a number of researchers and institutions. **choosier medicine names** that are least likely to be confused with existing medicines, **designing packaging that is easy to read,** for example, using non-reflective foil on blister packs, **large and clear fonts with contrast** to the background, appropriately aligning text for easy reading, emphasising the difference between look-alike or sound-alike (LASA) medicine names using colour, font size or Tallman lettering (e.g. ChlorproPAMIDE and ChlorproMAZINE) and between strengths of the same medicine ensuring that company logos / images do not break the text, **allocating space on packs for the dispensing label,** using dispensing labels of sufficient size and attaching these to the medicine packs appropriately,