packaging Flashcards
how many stages ‘packs’ are there
3
Pharmaceutical pack = stage 1
- includes container + closure; the closure is part of the pack
- closure happens by heat/pressure sealing
closure
- Child-resistant, senior-friendly
- tamper-resistant (difficult to tamper with), tamper-evident (it will be obvious if someone has tampered with it)
- Cap material, liner, inner seal (often no liner)
- Closure is very important as it may allow exchange of gases if seal is not good.
a pack can be single unit e.g a sachet or blisterpack
it can also be multiple unit e.g a bottle containing many tablets
single adv: you can see how many you have taken, each tablet is protected until you open it to take it
multdis: all tablets exposed to bacteria etc every time u open it
adv: more convenient to carry and easier to recycle
unit dosages has what 2 types of packaging
blister and strip
https://www.notion.so/packaging-15300bb3982d806494dbfcec591cb91c?pvs=4#17b00bb3982d800d8901c8b657e379e3
advantages of blister and strip packaging
convenient
patient education
compliance
tamper evident
stability
packaging that can’t be separated from the medicine
asthma inhalers and patches go two in two
why is compatibility of the primary pack key
The primary pack is in direct contact with the medicine. It must be compatible with the medicine, and must not change it in any way.
The pack must take nothing out of the product and add nothing in. e.g. how glass won’t get into your medicine
why do we need packs for medicine?
The pack provides:
- containment
- protection
- presentation
- identification
- information
- convenience
- compliance aids eg spoons
example: packing covid vaccines:
consider vaccine stability to heat or storage
if not stable e.g. if sensitive to heat, and isn’t immediately put back in fridge etc, we cannot administer it, so must be thrown away, as no way to check
→ leads to lots of vaccine wastage
recently. vaccine vial’s have a sticker like vaccine vial monitor to check how long its been left out & how long? it changes colour to show thi
role of packaging expanding
how?
?
- to combat counterfeiting e.g. scratching of a code to text to confirm if its fake or not
- To facilitate medicine administration by healthcare
practitoners and by patients, e.g. use of pre-filled
syringes, instead of drawing out from a multi dose bottle (ensures accurate dosing, however, even if using one vial, u need to use a new needle and syringe per patient due to contamination, and can lead to injuries) - To brand and promote products to the consumer
- To remind patients to take their medicines and track
their compliance
packaging must:
- Be chemically inert, compatible with product
- Protect product from mechanical hazard, environmental hazard etc
- Be accessible to the user
- Be child-resistant, tamper-resistant, tamper evident
- Keep its integrity in the distribution system
packaging materials:
Glass, plastics and metal - the most commonly used primary packaging materials.
Paper is used mainly in the secondary packaging. The latter holds/covers the primary pack. It can also be sashes
Rubber is used in closures
Laminates – consisting of plies (layers) of different materials such as paper, plastic and metal – combine the advantages of the different materials.
glass advantages and disadvantages
advantages: relatively unreactive and inert, does not allow gas transmission, easy to clean, transparent, can be steam sterilised, etc)
disadvantage: fragility, heavy weight, (reduced by surface
coating and good design)
glass characteristics
Consider type of glass, shape, volume, neck finishing,
colour, light transmission
Glass is composed mainly of silicon dioxide. Other oxides (which are loosely bound in the network) may also be present. There are different types of glass, some are more resistant than others. Need to consider application e.g. need for sterilisation
what types of glass are there
type I, II and III
Type I glass
also called borosilicate glass. the most inert, is highly resistant to temperature changes and the most expensive. It is used in ampoules and vials for liquid parenteral products, and to package slightly acidic solutions
Type II glass
it’s surface is treated to reduce the amount of ions that can leach out of the glass. Type II glass is suitable for solutions that can be buffered to remain below pH 7.
Type III glass – the next grade
– not used for aqueous parenteral preparations.
plastic properties
→ widely used as diff types: e.g. bottles, tubes, pouches, blister packs, bags etc
use as a material growing due to their advantages and consumer preference
diff plastics/polymers = diff properties
Some have better barrier properties than others. Some are a good
barrier to water vapour but a poor barrier to oxygen.
plastics also may have residues of additives from making them
plastic adv and disadvantages
advantages:
lighter than glass, resists breakage, lower cost. Flexible. Can be clear or opaque. Plastics are easily shaped and sealed, which gives great versatility in the design of the pack, and allows the inclusion of administration aids such as squeezable dropper
disadvantages:
permeable to water vapour, CO2, O2, allow light transmission, leaching of chemicals, poor impact resistance, not as clear as glass, many plastics often/melt if thermally sterilised. Disposal is an issue - usually of PVC, polystyrene etc
diff types of bottles
check notion notes week 15
https://www.notion.so/packaging-15300bb3982d806494dbfcec591cb91c?pvs=4#17b00bb3982d808d8ff2fee2e493126c
metals characteristics
usually aluminium and tinplate (a misnomer, a sheet of steel that is coated with a thin deposit of tin)
properties
Both soft and hard forms are used (e.g. hard for cans, soft for tubes).
Soft form can be crimped for sealing.
used in the form of cans, tubes, pouches, blister packs etc
metal disadvantages and advantages
advantages
- mechanically strong
- can withstand the high internal pressure in aerosol containers
- shatterproof
- lightweight (due to the fact that it is strong even when thin layers are used)
- impermeable to gases and light
- malleable
- it can be tailored in hardness and flexibility with respect to the desired container
disadvantages
Metal can however interact with the pharmaceutical
product. To isolate the metal from the product, the metal surface is coated with plastic. The outside of the metal container is also coated to protect the metal and to enable printing.
why collapsible metal tubes are good:
when squeezed to expel the product, e.g. a cream, the tube does not spring back into its original shape and air is not sucked back into the container, which could otherwise react with the product or cause it to dry out
paper: characteristics
diverse applications, e.g. Labels, leaflets, collapsible and
rigid cartons, bags, sacks, sachets.
- not used in the manufacture of the primary pack, apart from sachets, but then the paper is separated from the product by a layer of plastic/metal
defined as matted or felted sheet usually composed of natural plant fibre. When the paper material weighs 250 grams per square metre or more or is 300µm or more in thickness, it is known as paperboard
paper disadvantages and advantages
advantages of paper:
- relatively cheap, available, generally of non-toxic origin and easily
recycled. - readily torn or cut open, an advantage when paper is used in
sachets. - rigid and strong - allow its use in cartons. At the same time, it can act as a slight cushion and protect the primary pack.
- Its deadfold (ability to hold a crease) allows the making of cartons
and bags as well as its use for patient information leaflets. - It is easily printed and coated.
- the nature and properties of the finished paper can be controlled, such that paper may be ‘tailor-made’ for specific applications.
disadvantages:
- has no barrier properties against moisture, gases, odours.
- It is moisture-sensitive, has no heat or cold seal properties and hence cannot be sealed without adhesives or special coatings
- Is not transparent or glossy
how to overcome paper disadvantages
paper can be combined with
other materials. For example, paper can be further coated by polymers, or laminated to plastic or to aluminium foil to improve its barrier properties to gases and moisture, and to create heat-sealing ability when used in the primary pack.
laminates: xtra info
A laminate is made by bonding together two or more plies of
different materials, such as paper, plastic and metal.
The aim is to combine the desirable properties of the different plies
into a single packaging structure.
A minimum amount of material is used and the laminate is cost- effective.
In sachets, blister packs, tubes, pouches, etc.
E.g. a structure consisting of paper/foil/polythene plies, used for sachet packaging. The paper provides strength, printability and the ability to easily tear the package, the foil provides an excellent barrier to light, moisture and gases and the polythene enables heat sealability.
xtra info on rubber e.g. how they aren’t totally inert
Rubber (elastomer = a natural or synthetic polymer having elastic properties) is often used.
Rubber closure is held by an aluminium cap.
Natural or synthetic sources; rubber trees or derived from petrochemicals.
Common pharmaceutical examples - butyl, chlorobutyl, natural and silicone elastomers.
Like other plastics, rubbers are not totally inert. They are permeable to some extent, they may also absorb components of the packaged product and may leach residues and low- molecular weight components into the packaged contents
packaging for product stability
- must be compatible with the product: take nothing out and add nothing in
- sorption (absorption or adsorption) of the drug or other excipients
such as preservatives, into the container would reduce product potency and stability, while chemicals leaching out of the container and into the product could induce drug degradation. - Solvent loss from a product can also occur if the container is
permeable, which could result in drug and excipient precipitation.
Pack must protect product against atmospheric factors eg
* extremes of temperature
* light
* moisture
* oxygen
* carbon dioxide
* particulates (e.g. dust, dirt)
* biological hazards, such as microorganisms, insects and rodents
why does a pack have to protect from all those factors
Heat can degrade a drug/ vaccine. Remember vaccine vial monitors?.
Light can provide the energy necessary for a drug isomer to change its configuration.
Oxygen can cause drug degradation via oxidation.
Carbon dioxide can dissolve in the water in unbuffered aqueous products, and lower their pH by forming carbonic acid.
Moisture can cause drug degradation via hydrolysis. Moisture gain into a product can also cause dilution of liquid products, wetting of solid products and an aqueous environment, which can support microbial growth.
substances which remove hazards
Dessicants (e.g. silica gel, bentonite, calcium chloride, calcium oxide,
molecular sieves, carbon) and oxygen absorbers (such as iron oxide,
StabilOx) may be used.
aside from desiccants and oxygen absorbers how else can we remove hazards
Some products e.g. PharmaKeep absorb both moisture and oxygen.
* Absorbers are contained within sachets or canisters that are placed inside containers, or can be integrated within the container walls, for example, in Oxy-Guard barrier bottles or integrated within the container closures.
* combo of an impermeable container and a moisture/oxygen absorber sachet may also be used, the impermeable container protecting against degradation that could arise from moisture/oxygen from the atmosphere ingressing into a container and the sachet absorbing any moisture/oxygen
Secondary and tertiary packs also contribute to protection - how?
- against atmospheric factors to some extent e.g. light. However, their major role is to provide protection against mechanical hazards e.g. shock when dropped, compression, vibration, abrasion, puncture etc during handling, storage
and transport.
Original Pack Definition:
Designed for direct dispensing to the patient without changes, except for adding appropriate labels
Repackaging in Pharmacy Settings:
- Purpose:Often required in hospitals or community pharmacies to transfer medicines into different packaging.
- Common Scenarios:Typically involves tablets and capsules, but can include liquids like methadone.
Key Considerations for Repackaging:
-
Primary Container Selection:
- Ensure good containment and protection of the medication.
- Verify compatibility between the product and the container material.
-
Risk and Stability Factors:
- Assess potential forerrorsduring repackaging.
- Considerphysical and chemical stabilityof the medicine.
- Maintaincleanlinessto avoid cross-contamination.
- Evaluate theshelf-lifeof repackaged products.
-
Legal and Labelling Requirements:
- Comply with legal standards and guidelines.
- Provide clear and accurate labelling for safety and compliance.
packaging and regulatory bodies
the pharmaceutical packaging is subject to regulation and approval by government agencies such as the United States Food and Drug Administration (FDA), and the UK’s Medicines and Healthcare products regulatory agency (MHRA). This is as it’s considered part of the product.
why is packaging and safe medicine use so key
- as 1/4 of med errors due to similar med names or packaging
good med naming practice includes:
Actions that would result in clearer and safer packaging, such as global standardisation of the packaging, have been recommended by a number of researchers and institutions.
choosier medicine names that are least likely to be confused with existing medicines,
designing packaging that is easy to read, for example, using non-reflective foil on blister packs,
large and clear fonts with contrast to the background, appropriately aligning text for easy reading,
emphasising the difference between look-alike or sound-alike (LASA) medicine names using colour, font size or Tallman lettering (e.g. ChlorproPAMIDE and ChlorproMAZINE) and between strengths of the same medicine
ensuring that company logos / images do not break the text,
allocating space on packs for the dispensing label,
using dispensing labels of sufficient size and attaching these to the medicine packs appropriately,
