Packaging of medicines

By silvano
 Packaging of Dispensed Medicines
• Medicines must be contained, protected and labelled appropriately, from the time of
manufacture until the time they are used by a patient, in order to maintain their
effectiveness as a medication, as well as allowing for accurate dispensing of the
required dosage form, strength and quantity

• The function of a container for a medicinal product is to maintain the quality, safety
and stability of its contents.
The package system should:
1. Provide an adequate barrier to microorganisms, particulates, and fluids
2. Maintain sterility of package contents until opened (for sterile products)
3. Protect package contents from physical damage during handling and transport
4. Provide adequate seal integrity
5. Be tamper-proof and able to seal only once
6. sufficiently transparent to allow for inspection of the contents in the case of liquid
preparations
7. Be constructed of materials that do not react with the medicine (inert)
8. Be easy to open and close, if required, especially if the medication is for an elderly
or arthritic patient
Types of packaging
• Packaging materials are divided into two categories
Primary packaging
secondary packaging

• They have different roles in protection and delivery of the medication to the
patient
Primary packaging
• Primary packaging (or immediate packaging) is material that comes into direct
contact with the medicine, which also includes the closure.

• This material must protect the medicine from damage and from extraneous
chemical and microbial contamination

• It should support use of the product by patient.

Secondary packaging
• Secondary packaging is the additional material that improves the
appearance of the medicine.
• It includes boxes wrappers and labels that do not make direct
contact with the dispensed product.
• These are often used to supply information to the patient about the
product.
• Often times, they show if the packaged product has been tampered
with.
Types of primary and secondary packaging
materials and their use

Material Type Examples of use

Glass Primary Metric medical bottle, ampoule, vial
Plastic Primary Ampoule, vial, container, infusion fluid dropper bottle
Plastic Secondary Wrapper to contain primary pack
Board Secondary Box to contain primary pack
Paper Secondary Labels patient information leaflet
 Paper
• Paper has been used as a packaging material in pharmacy for longer than any other
material. Although in modern day pharmacies, paper is used largely as a secondary
packaging material as a carton to hold the primary packaging material , early medicines
of dried herbs or minerals such as chalk were powdered and supplied in paper packets

• Indeed paper has also been used as part of the dosage form – unpleasant tasting
powders were some times wrapped in a rice paper wafer, softened by dipping in water
then swallowing with a draught of water

• This idea was further developed in France by Limousin of Paris in 1870s with the
cachet, 2 rice-paper cups which were joined together with powder inside. This was the
origin of the capsule
 Glass
• Historically, glass has been
widely used as a drug
packaging material. It
continuous to be a perfect
packaging material for many
pharmaceutical products.
Glass does have several advantages
• It is inert to most medicinal products
• It is impervious to air and moisture
• It allows for easy inspection of the contents
• It can be colored in order to protect the contents from light when required
• It is easy to clean and sterilize by heat
• It is available in variously shaped containers
• It can be sealed to completely enclose a dosage form
Disadvantages of glass
1. It is fragile. Glass fragments can be released into the product during transport
2. Certain types of alkali into the container contents
3. Its expensive when compared to the price of plastic
4. It is heavy resulting to increased transport costs.

Hydrolytic resistance
• The chemical stability of glass for pharmaceutical use is given by the resistance of glass to
release soluble minerals into water contacting the glass. This is known as hydrolytic
resistance
Glass categories
• According to the European Pharmacopeia, medical packaging glass
is divided into 3 main categories based on chemical composition.
• Type I- neutral or borosilicate glass
• Type II - soda lime silicate glass
• Type III- soda lime silicate glass
 Type I-Neutral or borosilicate glass
• This is the least chemically reactive type of glass (has high hydrolytic
resistance)
• It also does not expand or crack on exposure to temperature changes.
• It is mainly used to package all pharmaceutical preparations
• Its expensive and this restricts its applications
• Used:
Widely used as glass ampoules and vials to package fluids for injection
To package solutions that basic oxides in the glass
Type 1-Neutral or borosilicate glass
Type II soda lime- silicate glass
• This type is chemically treated so that the inside surface is as unreactive as type I
glass.
• Glass treated with Freon or sulphur dioxide.
• This type of glass may react with chemicals in the medicines and it is
recommended they are used only once before disposal.
• The above is because of the possibility of break down of the internal surface layer
• Has lower melting point than type I glass
• It is used largely to produce containers for eye, ear and nasal drops.
Type III- soda lime–silicate glass
• This is made of soda-lime-silicate glass
• It has the same composition as type II glass but contains more leachable
oxides
• Offers only moderate resistance to leaching and is used to produce
dispensary metric bottles.
• Suitable packing non-aqueous parenteral products and powders for injection.
Types of glass containers commonly used in
pharmacy
• Bottles
• Dropper bottles
• Jars
• Ampoules
• Multi dose vials
Bottles
• Bottles may be;
amber metric medical bottles, or
ribbed oval bottles
• Amber bottles are used to carry a wide range of oral medications

• Ribbed oval bottles have flutes down one side of the container
• The characteristic feel of the flutes warns the user that the contents are not to be
taken
• A label is attached to the plain front of the bottle
• Ribbed (or fluted) bottles are used to package medical products that should not
be used orally. E.g. liniments, lotions, inhalations and solutions
• They were traditionally used to dispense poisons.
Bottles
 Dropper bottles
• Are used to contain medicinal products
for application to the eye, ear and nose.
• Are usually hexagonal and fluted on three
sides.
• They are fitted with a combined cap,
rubber teat and dropper as the closure
mechanism.
• The bottles are used at capacity of 10 mL
or 20 mL
 Jars
• Wide-mouthed cylindrical jars made
of clear or amber glass are used in
situations where contamination
from patients fingers will not affect
the product stability.
• Considered for creams and
ointments.
• Capacity of these jars ranges from
15 mL to 500 mL
Multi dose vials
• Are used to store injection solutions that will be used more than once.
• They are usually sealed with a rubber plug that is held in place by an aluminium
sealing ring.
• The bung is made of special material that can be pierced by needle many times,
without any loss of sealing properties.
• This is for continuous protection against
moisture and bacteria.
 Plastics
Two classes of plastics are used in packaging pharmaceutical products
1. Thermosets -Used for making screw caps for glass and metal containers
2. Thermoplastic polymers -Used to make a wide range of pharmaceutical packages

Polymer Examples of application

High-density polyethylene Solid dosage form containers
Low-density polyethylene Flexible eye drop bottles
Linear Low-density Heat-sealable containers
polyethylene
Polypropylene Container closures, i.v solution bottles
Polyvinyl chloride Laminate for blister packs, i.v bags
Polystyrene Containers for oils and creams and solid dosage forms
Advantages of plastics for packaging
1. Release few particles into the product
2. Are flexible and not easily broken
3. Are of low density and thus light in weight
4. Can be heat sealed
5. Are easily moulded into different shapes
6. Are suitable for use as container, closure and as secondary
packaging
7. Are cheap
Disadvantages of plastics for packaging
• They are not chemically inert as type I glass
• Some plastics undergo stress cracking and distortion from contact with some
chemicals
• Some plastics are very heat sensitive
• They are not impermeable to gas and vapour as glass
• They may posses electrostatic charge which will attract particles
• Additives are easily leached into the product
• Substances such as drug actives and preventives may be taken from the
product
Plastic containers
• Plastic pharmaceutical containers are made of one polymer
together with additives such as:
Plasticizers
Resins
Stabilizers
Lubricants
Antistatic agents
Mould-release agent
Plastic containers
• Used for many types of packs including:
Rigid bottles for tablets & capsules
Squeezable bottles eye drops and nasal sprays
Jars
Flexible tubes
Strip and blister packs
 Metal
• Metal is often used in form of a collapsible metal tube as a primary
packaging material for creams and ointments.
• The tubes are made from aluminium, which remains collapsed as the
product is used by the patient.
• Aluminium foil is used in blister packaging to form a moisture-impermeable
barrier that protects tablets and capsules held in plastic strips.
• Strip packaging of medicines sensitive to light and moisture involves
sealing each individual dosage unit (tablet or capsule) in a foil ‘pouch’ on a
strip of 7-10 units
• This individual wrapping of the medicine protects it from exposure to light
and/or moisture which cause breakdown of the drug.
 Closures
• Closures are defined as part of medicine packaging material by the BP.
• They should provide an effective seal to retain the dispensed medications within the
packaging and also protect the contents from contamination.
• The majority of loose medication dispensed from a bulk supply provided by a
manufacturer is packaged into a plastic or glass bottle with a CRC.
• The most common ‘push down and turn’ cap CRC is known as a ‘Clic Loc’
• Other are
• Cap-bottle alignment systems
• Squeeze and turn caps
Closures
• Use of a CRC should not be considered as an absolute barrier to children.
• Patients should always be advised to store medications in a safe place that is
out of reach and sight of children.
• Other closures include a rubber stopper used to seal multi dose injection vials,
which reseals after perforation by a needle.
• It can also undergo heat sterilization- once the medication has been placed
into the vial by the manufacturer and the rubber stopper inserted.
Unit-dose packaging
• This term usually means that a single item such as tablet or capsule or
specific dosage is enclosed within its disposable packaging.
• The most commonly used methods for unit-dose packaging are blister and
strip packs
 Blister packs
• Are used for packing unit doses of tablet and capsules and can act as an aid for patient
compliance
• The medication is placed in a compartment in a base material made of paper, board,
plastic or metal foil or a combination of these.
• The blister is generally composed of thermoformed plastic such as PVC
• Perforations in the base material allow individual sections of the package to be broken
off.
• Blister packs are rigid, unlike strip packs that are flexible
Strip packaging
• Two webs of material sandwich various types of medicine such tablets,
capsules, suppositories or pessaries
• The composition of the two webs can be selected to meet the necessary
protective requirements of the medicine
• Aluminium foil is commonly used to manufacture strip packs and provide a
good barrier against moisture penetration.