Pharmaceutical Packaging Flashcards
What are properties of ideal packaging?
*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
What is immediate packaging?
One in direct contact with product
What is secondary packaging?
Not in direct contact- paper or card, adds protection
Why is it important to protect from moisture?
Hydrolysis. Especially those containing a carboxylic acid
Suppers organism growth
Caking of powders
Tarnishing of metals
Loss of water
DESICANTS
How is light protection carried out?
Using opaque bottles. Prevents instability
Why is it important to protect from gas?
Oxidation- initiation, propagation, termination
CO2 can reduce pH
Use of antioxidants- donate election to free radical without becoming unstable. Stops chain reaction- ascorbic acid
What are advantages of using glass as a package?
*mouldable to rigid constructions
*can be made clear or amber
*impermeable to moisture
*cheap
*easy labelled
*easy sterilised
What are disadvantages of glass as packaging?
*fragile- broken easy
*heavy- higher transport cost
*may release small glass fragments inside (lamellae)
What is soda glass?
*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
What is a disadvantage of soda glass?
*liable to fracture with sudden temp change
What is amber glass?
For light sensitive drugs
Contains iron oxide
What is borosilicate glass?
*Better than soda- decreased proportion of alkali- includes boric acid
*heat resistance improved, chemical durability
What is a disadvantage of borosilicate glass?
*expensive, difficult to melt and mould
What are the two main categories of plastics in packaging?
*thermosetting
*thermoplastic
What are the advantages of using plastics as packaging?
*less brittle than glass
*lightweight- low transport cost
*readily mouldable
*suitable for containers and closures
What are plastics made from?
Oil
What are disadvantages of plastic as packaging?
*wont withstand significant heat without distorting
*permeable to water vapour and gases
*may absorb substances from solution
What kind of plastics show greater gas permeability and how is this resolved?
Lower dense plastics
Add fillers (inert clay)- lengthens route of diffusion
What are the differences between thermosets and thermoplastics?
*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
What is an example of a thermoplastic ?
Polyethylene (PE) at low density (more economical).
LDPE- bags
HDPE- rigid bottles
What is another example of a thermoplastic?
PVC-
Non plasticised- bottles and blister packs
Plasticised- used for tubing, infusion bags
What are biopolymers?
Sustainable but synthetic packaging derivatives due to oil supply and cost issue
What are we worried about in terms of drug packaging?
*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
What is the effect of DEHP leaching in PVC bags?
Toxic effects on male neonate reproductive system, lungs, heart, kidneys
Carcinogenic
What is the issue with aluminium contamination?
If in parenteral nutrition, it’s neurotoxic
Aluminium added to glass to improve chemical resistance
Why does drug sorption happen with plastics?
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
What equation is used to approximate the affinity of API for PVC?
P= concn in hexane/ concn in water
Higher= higher sorption = bad
