Packaging Technology

7/17/2019 Packaging Technology

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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



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)]-



• glass transition temperature (Tg): -10C




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

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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]-



• glass transition temperature (Tg): 85C





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


Poly(vinylidene chloride) (PVdC)

• Vinylidene chloride monomer: CH2=CCl2

• Poly(vinylidene chloride) repeating unit: -[CH2-CCl2]-



• glass transition temperature (Tg): 10C


• density similar to PVC


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


Poly(chlorotrifluoroethylene) (PCTFE) (Aclar)

• Chlorotrifluoroethylene monomer: CClF=CF2

• Poly(chlorotrifluoroethylene) repeating unit: -[CClF-CF2]-



• glass transition temperature (Tg): 72C• melting point: 211C

• density approx 2 g/cm3






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



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

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Packaging Technology