packaging technology
DESCRIPTION
Different Technology in packaging pharmaceuticals.TRANSCRIPT
7/17/2019 Packaging Technology
http://slidepdf.com/reader/full/packaging-technology 1/5
M.Pharm. Year 2
PHAY 2002
Medicines from the bench to the clinic
Packaging Technology
for Solid Oral Dosage Forms
Dr Susan Barker
February 2015
Packaging Technology
Learning objectives
At the end of the lecture, you should be able to describe:
• The common types of pharmaceutical packages used for tablets
and capsules, with their concomitant advantages and
disadvantages
• The materials used in these packages and the rationale for
selecting an appropriate one
• The process of making blister packs
2
Why do we need packaging? Why do we need packaging?
• Easier to handle the product
• eg liquids
• Chemically / physically protect the product
• eg prevent oxidation or evaporation
• Protect integrity of the product
• eg prevent tablets being crushed
• Product identity
• eg labelling
• Ease of use
• eg eye drops, injector pens
Types of pharmaceutical packaging Types of pharmaceutical packaging
• Bottles • Blisters
• plastic, glass • plastic, metal
• CR, non-CR • peelable, push-through
• Strips • Sachets
• metal • paper (lined)
• Tubes • Speciality / functional• plastic, metal • injector pens
7/17/2019 Packaging Technology
http://slidepdf.com/reader/full/packaging-technology 2/5
Glass bottles
• See Dr Orlu Gul's lecture from PHAY 1004
• Advantages
• Looks professional
• Good resistance against moisture vapour permeation
• Can have a CR or non-CR closure
• Disadvantages
• Heavy
• Breakable
• Can't be made into a
"calendar pack"
• Tamper-evidency is poor
Plastic bottles
Poly(ethylene) (PE)
• Ethylene (ethene) monomer: CH2=CH2
• Poly(ethylene) repeating unit: -[CH2-CH2]-
• Final molecular weight variable
Plastic bottles
Poly(ethylene) (PE)
• Chemical arrangement of polymer chains varies
• linear closer packaginghigher density (HDPE)
• branched looser packaginglower density (LDPE)
• Important physical properties:
• glass transition temperature (Tg): -78C
• melting point: 100C
• amorphous density at 25C: 0.855 g/cm3
• crystalline density at 25C: 1.00 g/cm3
Plastic bottles
Poly(propylene) (PP)
• Propylene (propene) monomer: CH3-CH=CH2
• Poly(propylene) repeating unit: -[CH3-CH(CH3)]-
• Final molecular weight variable
• Important physical properties:
• glass transition temperature (Tg): -10C
• melting point: 173C
• amorphous density at 25C: 0.85 g/cm3
• crystalline density at 25C: 0.95 g/cm3
Plastic bottles
Poly(ethylene) (PE) and poly(propylene) (PP)
• Usually made opaque white with TiO2
• Advantages
• Cheap and easy to manufacture
• Non-breakable and robust
• Can have a CR or non-CR closure
• Disadvantages• Fairly permeable to moisture and oxygen
• Can't be made into a "calendar pack"
• Tamper-evidency is poor
Plastic blisters
• Composed of "base film" and "lidding foil"
• Base film can be clear, opaque white (TiO2) or coloured
• Lidding foil can be "peelable" or "push-through"
• Important information can be printed on the pack
• manufacturer's name and logo, name of product, batch
number, expiry date, PL and ML numbers, POM/P
• Tamper-evidency for individual tablets / capsules
• Can easily be made into a calendar pack
7/17/2019 Packaging Technology
http://slidepdf.com/reader/full/packaging-technology 3/5
Plastic blisters - process
• Thermo-formed
• Process:
• roll of polymer film for base
• make cavities using heated plate
• fill cavities with tablets or capsules
• seal with lidding foil
• cut blisters into correct lengths
• pack into cartons
https://www.youtube.com/watch?v=lUPWpyA2B2U
Plastic blisters - base film
Poly(vinylchloride) (PVC)
• Vinyl chloride monomer: CH2=CHCl
• Poly(vinylchloride) repeating unit: -[CH2-CHCl]-
• Final molecular weight variable
• Important physical properties:
• glass transition temperature (Tg): 85C
• melting point: 240C
• amorphous density at 25C: 1.385 g/cm3
• crystalline density at 25C: 1.52 g/cm3
Plastic blisters - base film
Poly(vinylchloride) (PVC)
• Needs plasticiser
• eg dioctyl phthalate
• plasticiser Tg flexibility and barrier properties
• risk of leaching toxicity profile must be known
• Permeable to moisture and oxygen
• Can be used as a mono-layer film
• typically 200 to 300 microns thick
Plastic blisters - base film
Poly(vinylidene chloride) (PVdC)
• Vinylidene chloride monomer: CH2=CCl2
• Poly(vinylidene chloride) repeating unit: -[CH2-CCl2]-
• Final molecular weight variable
• Important physical properties:
• glass transition temperature (Tg): 10C
• melting point: 155C
• density similar to PVC
Plastic blisters - base film
Poly(vinylidene chloride) (PVdC)
• Is used without a plasticiser, but is brittle
• Less permeable to moisture and oxygen than PVC
• Can't be used as a mono-layer film (too brittle)
• use as a duplex with PVdC layer on PVC
• use as a triplex with PVdC / PE / PVC layers
• define thickness of PVdC layer in g/m2, typically 40, 80, 120
• More expensive than PVC
Plastic blisters - base film
Poly(chlorotrifluoroethylene) (PCTFE) (Aclar)
• Chlorotrifluoroethylene monomer: CClF=CF2
• Poly(chlorotrifluoroethylene) repeating unit: -[CClF-CF2]-
• Final molecular weight variable
• Important physical properties:
• glass transition temperature (Tg): 72C• melting point: 211C
• density approx 2 g/cm3
7/17/2019 Packaging Technology
http://slidepdf.com/reader/full/packaging-technology 4/5
Plastic blisters - base film
Poly(chlorotrifluoroethylene) (PCTFE) (Aclar)
• Needs a plasticiser
• Less permeable to moisture and oxygen than PVdC
• Can't be used as a mono-layer film (not mechanically strong
enough)
• use as a duplex with PVC or PP
• define thickness of PCTFE layer in g/m2, typically 40, 80, 120
• More expensive than PVdC
Plastic blisters - lidding foil
Push-through lidding foil
• Aluminium coated with adhesive
• product contact material is the adhesive
• Generally about 20 microns thick
• Most common
Peelable lidding foil
• Push-through lidding foil with an additional layer of paper
• Less common
• More child-resistant than push-through
Metal blisters
• "Cold-formed aluminium" (CFA)
• aluminium foil triplex base film
• Structure
• outer layer is oriented nylon or oriented polyamide (OPA) for
mechanical strength• middle layer is aluminium for barrier properties
• inner layer is PVC, PP, PE to aid sealing to lidding foil
Metal blisters
• Lidding foil the same as for thermoformed plastic blisters
• Process:
• same as for thermoformed plastic blisters
except:
• make cavities using pressurised plate at room temperature
• Aluminium is a "perfect" barrier to moisture, oxygen and light
• much better than the thermoformed plastic blisters
• Pockets are very large compared to tablet / capsule size
• aluminium is very brittle, so sides of the pockets have to be
very shallow
• not good for very large tablets / capsules
Blister packs - summary
Advantages
• Patient acceptability
• Easy to transport
• Relatively easy to manufacture
• Barrier properties can be easily varied to suit the sensitivity to
moisture / oxygen / light of the drug
• Can easily be made as calendar packs
• Tamper evident at the individual tablet / capsule level
• Professional appearance
Blister packs - summary
Disadvantages
• Difficult to make CR
• Possible leaching of plasticisers
• into product concerns about toxicity
• into environment embrittlement of plastic ?
• Chlorinated polymers
• environment concerns ?
• Adhesive is product-contact
• compatibility and toxicity ?• CFA requires large pockets
• bulky
7/17/2019 Packaging Technology
http://slidepdf.com/reader/full/packaging-technology 5/5
Metal strip packages
• Aluminium foil with adhesive layer
• Thermo-formed
• Process:
• two rolls of aluminium film
• seal foil around each tablet individually
• Can be strip or single sachets
• Product contact material is the adhesive
Metal strip packages
Advantages
• Similar to metal blisters• Cheap
Disadvantages
• Similar to metal blisters
• Not such a professional appearance as blisters (looks cheap)
Summary
Selection of the most appropriate package for tablets and capsules
is dependent on:
• Moisture, oxygen or light sensitivity of the product
• Low sensitivity : PVC blisters or HDPE bottles
• High sensitivity : CFA blisters or HDPE bottles with desiccants
• Select blister base material by product sensitivity
• PVC < PVdC < PCTFE < CFA for protection
• Select blister base material by cost
• PVC < PVdC < PCTFE = CFA for cost