Pharmaceutical Packaging

Question 1

What are properties of ideal packaging?

Answer 1

*protection- prevent spoilage, protect from mechanical damage, protect from tamper
*inert- no chemical interaction with product across range of storage conditions
*appearance- suitable for market, easy to label, paper leaflets?
*convenient- easy to use and handle, should help aid compliance

Question 2

What is immediate packaging?

Answer 2

One in direct contact with product

Question 3

What is secondary packaging?

Answer 3

Not in direct contact- paper or card, adds protection

Question 4

Why is it important to protect from moisture?

Answer 4

Hydrolysis. Especially those containing a carboxylic acid
Suppers organism growth
Caking of powders
Tarnishing of metals
Loss of water
DESICANTS

Question 5

How is light protection carried out?

Answer 5

Using opaque bottles. Prevents instability

Question 6

Why is it important to protect from gas?

Answer 6

Oxidation- initiation, propagation, termination
CO2 can reduce pH
Use of antioxidants- donate election to free radical without becoming unstable. Stops chain reaction- ascorbic acid

Question 7

What are advantages of using glass as a package?

Answer 7

*mouldable to rigid constructions
*can be made clear or amber
*impermeable to moisture
*cheap
*easy labelled
*easy sterilised

Question 8

What are disadvantages of glass as packaging?

Answer 8

*fragile- broken easy
*heavy- higher transport cost
*may release small glass fragments inside (lamellae)

Question 9

What is soda glass?

Answer 9

*made from silica, limestone and soda ash
*small amount of MgO- reduces temp required for manufacture
*small amount of AL2O3- improved mechanical strength and durability
*easy to make

Question 10

What is a disadvantage of soda glass?

Answer 10

*liable to fracture with sudden temp change

Question 11

What is amber glass?

Answer 11

For light sensitive drugs
Contains iron oxide

Question 12

What is borosilicate glass?

Answer 12

*Better than soda- decreased proportion of alkali- includes boric acid
*heat resistance improved, chemical durability

Question 13

What is a disadvantage of borosilicate glass?

Answer 13

*expensive, difficult to melt and mould

Question 14

What are the two main categories of plastics in packaging?

Answer 14

*thermosetting
*thermoplastic

Question 15

What are the advantages of using plastics as packaging?

Answer 15

*less brittle than glass
*lightweight- low transport cost
*readily mouldable
*suitable for containers and closures

Question 16

What are plastics made from?

Answer 16

Oil

Question 17

What are disadvantages of plastic as packaging?

Answer 17

*wont withstand significant heat without distorting
*permeable to water vapour and gases
*may absorb substances from solution

Question 18

What kind of plastics show greater gas permeability and how is this resolved?

Answer 18

Lower dense plastics
Add fillers (inert clay)- lengthens route of diffusion

Question 19

What are the differences between thermosets and thermoplastics?

Answer 19

*thermosets have a single process- cannot be reshaped after
*thermoplastics can withstand repeated cycles of softening, melting etc
*thermosets are hard and tougher than thermoplastics
*thermosets expensive so cost limit to premium items- thermoplastics cheap
*thermoplastics used more often

Question 20

What is an example of a thermoplastic ?

Answer 20

Polyethylene (PE) at low density (more economical).
LDPE- bags
HDPE- rigid bottles

Question 21

What is another example of a thermoplastic?

Answer 21

PVC-
Non plasticised- bottles and blister packs
Plasticised- used for tubing, infusion bags

Question 22

What are biopolymers?

Answer 22

Sustainable but synthetic packaging derivatives due to oil supply and cost issue

Question 23

What are we worried about in terms of drug packaging?

Answer 23

*extractables- compounds can be extracted from packaging at extreme conditions.
*leachables- compounds can leach passively into drug formulation especially if organic formulation- plasticisers, antioxidants
*drug absorption- into or onto packaging- reduced drug potency

Question 24

What is the effect of DEHP leaching in PVC bags?

Answer 24

Toxic effects on male neonate reproductive system, lungs, heart, kidneys
Carcinogenic

Question 25

What is the issue with aluminium contamination?

Answer 25

If in parenteral nutrition, it’s neurotoxic
Aluminium added to glass to improve chemical resistance

Question 26

Why does drug sorption happen with plastics?

Answer 26

API ADsorbed onto plastic surface
Followed by diffusion into plastic
NOTE- ionised API more water soluble (stays in solution, less likely to be adsorbed) Non ionised API hydrophobic
So
Increased pH of an acidic compound= ionised API which remains in solution= less loss to sorption

Question 27

What equation is used to approximate the affinity of API for PVC?

Answer 27

P= concn in hexane/ concn in water
Higher= higher sorption = bad