(21) Pharmaceutical packaging 1 Flashcards
(32 cards)
how do we classify pharmaceutical glass)
Type 1 (high resistance, least reactive, high cost)
to
type 4 (low resistance, most reactive lower cost_
Outline compliance and adherence.
- compliance aid
- blister packs, help patients remember to take their medication - Specialised packing for specific populations
- eg arthritis friendly caps for easy opening - Portability
- slim packing to fit in pocket - Dosage control
- eg metred dose inhaler / insulin pens
outline packaging and information.
- clear labelling is important for patients
- key information needed eg dosing and warnings
- marketing and brand recognition
outline preservation and contamination.
- preservation against microbiological contamination (sterile packaging + air tight seals)
- particularly important in injection (IV)
outline protection of pharmaceutical
- temperature control (increased temp increases rate of reactions)
- moisture control (hydrolysis + supports growth of microorganisms + dilution of product)
- light (photodegradation - especially UV light)
- atmospheric gases (mainly carbon dioxide + oxygen (oxidation reactions))
what application does glass have?
primary packaging
- vials, ampoules, bottles, jars
- widely used for liquids, semi solids and solids
what are advantages and disadvantages of of glass?
Advantage:
- easy to mould
- cheap
- easy to sterilise
- impermeable to gas and moisture
disadvantages:
- fragile (easily broken)
- heavy (transport costs)
what are the types of glass used?
- soda glass (mostly silica - 72%)
- reduced temperature needed to produce
- improved mechanical strength and chemical durability
- adds some amount of alkali to the water solutions (disadvantage) - Amber glass
- similar to soda glass but iron oxide added
- this gives colour which provides block to UV light absorption - Borosilicate
- overcomes defects of soda glass by decreasing alkali
- boric acid is very temperature resistant
- very expensive to make (disadvantage)
what is hydrolytic resistance
Resistance to the release of soluble mineral substances into water under prescribed conditions of contact
what is pharmaceautical packaging
collection of different components which surround the pharmaceutical product from the time of its production to its use.
what is primary packaging?
- the packaging materials that are directly in contact with the product eg blister packs / strip foil packaging
- it should not interact physically or chemically with the product
what is secondary packaging?
- pack component with no physical contact
- usually made by paper or card
- useful to contain information and labelling
what is tertiary packaging?
- further packaging that surrounds the secondary packaging
- useful for logistics and supply chain management
what is the purpose of pharmaceutical packaging?
- Protection and containment
- Preservation
- Presentation and information
- Compliance
who regulates the pharmaceutical packaging?
MHRA, underpinned by the human medicines regulations 2012
Explain the general properties of thermoplastics
• Can withstand repeated thermal cycles to soften/melt/mould
• Formed by techniques including injection moulding, blow moulding, extrusion, lamination
• Usually resistant to breakage
• Cheap to produce and therefore used more often than thermosets
outline aluminium.
• Foil for blister packs
• Excellent barrier properties and can totally exclude
moisture, oxygen/other gases, microorganisms, and light
• This can help to maintain degradable products in peak
condition for long periods
• The manufacturing processes mean that the foil is sterile
when formed
• Other advantages:
• Can be printed on
• Flexibl
outline an example of extractable / leachables.
Leaching of DEHP from PVC bags (plasticising agent)
- Plasticised PVC is used for IV and blood bags and infusion tubing, enteral and parenteral nutrition feeding bags, and tubing used in cardiopulmonary bypass devices
- DEHP has been detected in liquids stored in plasticised PVC
- DEHP has shown a wide range of toxic effects on the male neonate reproductive system development, as well as on lungs, heart and kidneys, and it has been classified as possibly carcinogenic by The International Agency for Research on Cancer
Outline plasticised PVC (thermoplastics)
- Plasticised PVC: The addition of a plasticise
Disadvantages
• Lowers strength
• Lowers melting point
• Decreases barrier properties
• Leaching of DEHP associated with health concerns
• Not easily recyclable
Uses
• Widely used for tubing, infusion bags and other
similar medical devices
outline Polyethylene (thermoplastic) outline what increased / decreased density PE is associated with
- properties are relates to high and low density forms
- this is the most common and economical packaging plastic
- Increased density:
• Greater rigidity
• Higher distortion and melting temperatures
• Lower gas and vapour permeability
• Increased tendency to crack - Low density
• LDPE is used for flexible packs e.g. bags, dropper bottles
Outline polypropylene (thermoplastic)
• Similar to PE, except every fourth H is replaced by a methyl (CH3) group
• Suitable for rigid packs
• Good resistance to most chemicals, except organic solvents
• Similar barrier properties to HDPE
• Better resistance to higher temperatures than HDPE,
therefore more suitable for steam sterilisation
• More brittle at lower temperatures than PE
outline problems with plastics and gas permeability.
• Gas molecules can diffuse through plastics
• Different plastics have different gas permeabilities, with lower density plastics showing greater gas permeability
• The addition of fillers (inert clays or fibres) can reduce permeability by lengthening the route of diffusion
outline rubber
• Used to produce air-tight closures for bottles, cap liners, and bulbs for dropper assemblies
• Used in multi-dose vials and disposable syringes
• Natural rubber, and neoprene and butyl/nitrile rubber (synthetic rubbers) are most common
• Problems have been observed when rubber is in contact with parenteral solutions
outline some advantages and disadvantages of plastics in pharmaceutical packaging.
often where glass has disadvantages, plastics have the opposite advantages
- Advantages
• Good mechanical properties, even in thin-walled containers
• Less brittle than glass
• Relatively lightweight = reduced transport costs
• Readily mouldable into various geometries
• Suitable for containers and closures - Disadvantages
• Majority will not withstand significant heat without distortion
• Permeable to water vapour and atmospheric gases
• May interact with certain chemicals in a manner that alters material properties
• May absorb substances from solution
• May release substances into solution
• e.g. unpolymerised monomers or residues used in their processing
