Nancy: Packaging

Question 1

What are the three main things that are looked out for contains in storage of a drug?

Answer 1

1. Stability- challenge to keep product micro free
2. Compatibility- preventing API hydrolysis
3. Extra requirements- controlling hydrolysis kinetics by reducing water

Question 2

How do you keep H2O low using packaging?

Answer 2

1. Using silicon balls to absorb water

2. Sealing individually in controlled containers

Question 3

How may tablet packs benefit a [patient with Alzheimer’s disease and give another example of a population it benefits?

Answer 3

1. Allows for further organisation of doses so patients with Alzehmiers can take them more easily
2. Women taking combined oral contraceptive pill (day labelling)

Question 4

Give examples of a combined pack and applicator?

Answer 4

1. Eye drops
2. Nasal sprays
3. Pre filled syringes

Question 5

What are glass vials and ampoules generally used for?

Answer 5

1. Sterile solutions

2. Lyophilised freeze dried products

Question 6

What are the three different approaches for packaging sterile products?

Answer 6

1. Aseptic handling: keep it clean
2. Quality control and monitoring: spot the danger
3. Sterilisation: make it sterile

Question 7

Describe plastic properties in permeability, absorption and releasing properties?

Answer 7

1. Plastics have known permeability to water vapour, oxygen and other small molecules (organic and inorganic)
2. Many plastics absorb water- stoppers for freeze drying (must be dried in oven before use)
3. Plastic contain low Mw additives that can be released over time (monomers and plasticisers)

Question 8

Compare plastics (thermopolymers) to glass?

Answer 8

Plastics (thermopolymers)
Organic polymers in solid form

Primarily carbon chains

Typically high molecular weight and insoluble

Physiochemical properties many and varied (also customisable)

Glass:
Amorphous solid of SiO2 plus other minerals
Made of many different chemicals mainly SiO2
Physio-chemcial properties variable

Question 9

Why are glasses opaque?

Answer 9

Keep UV and light out

Question 10

Give examples of plastics that are used as packaging?

Answer 10

1. Polystyrene
2. PVC, PE, PP and COC
3. Fluoropolymers
4. Varying: Plasticisers, permeability, surface properties and transparency

Question 11

What are laminates in packaging?

Answer 11

1. Combines benefits of different materials- many clear plastics that are laminated 0.1mm layers of different polymers
2. Contain metal foil that are especially impermeable to gas and water vapour

Question 12

What is fibrous packaging and give examples?

Answer 12

1. Standard secondary packaging

2. Examples: Card and paper (fabric)

Question 13

What is the appearance and use of primary packaging and secondary packaging?

Answer 13

Primary Packaging:
1. Labelled Blister Pack

2. Ready to use form

Secondary packaging:
1. Usually branding

2. Sometimes critical to pharmacist and patient
3. Pack colour labelling

Question 14

What is the function and form of bottle stoppers that are found in ampoules?

Answer 14

1. Allows air to exit during drying
2. Simple mechanical closure
3. Allows sterile reconstitution
4. Foil cover secures and tracks seal