Pharmaceutics-Packaging Flashcards
what is the main purpose of packaging and labeling?
- provides clear unambiguous identification of the medicine and the conditions for safe use.
- helps maintain quality, safety, stability of medicine
what role do MHRA play in the packaging and labeling of medicines?
-they approve the packaging and labeling info for medicines sold in UK
what must be included in the outer packaging?
- name of medicinal product
- strength of medicinal product
- pharmaceutical of med
- intended for who (babies, children, adults?)
- active substances expressed qualitatively and quantitatively per dosage unit.
- excipients with an effect
- method and route of admin
- store out of reach & sight of kids
- expiry date
- storage precautions if any
- special warnings for the product if any
- special precautions
- precautions for disposal
- instructions for use
- space for dispensing label if POM
- name and address of MA holder
- batch number
what must appear on blister packs?
- name of product
- name of MA holder
- expiry date
- batch number
what must appear on immediate packaging?
- name of product
- method of administration
3. expiry date
4. batch number
5. contents by weight, volume or unit
what format must the medicinal product be in on the packaging?
both words and braille
what is used to help develop the PIL?
the summary of product characteristic (SPC)
what is primary packaging?
the packaging is in direct contact with the medicine and doesn’t react with the med and protects it from damage and contamination.
what is secondary packaging?
additional packaging improving the appearance of the product and doesn’t make direct contact with the med
what are the types of packages?
-single-dose containers
-multi-dose containers
-strip packs
-blister packs
-glass vials and ampoules
-sachets
-tubes
-bags
bottle for reconstitution
-pre-filled syringes
-light-resistant containers
-child resistant containers
what are closures used for?
provides an effective seal to retain the contents and exclude external contaminants
what must you consider when deciding which primary packaging to use?
- Function of packaging
- The dosage form
- Route of administration
- Stability
- Sterilisation need
- Visual inspection
- Patient compliance and convenience
- Cost
- Environmental-friendliness etc..
what are the advantages to using glass packages?
- inert and compatible with most drugs
- excellent barrier properties
- stable at high temperatures
- clear and allows visualisation of content
- coloured to protect content from harmful UV light
what are the disadvantages to using glass packages?
- costly
- heavy
- brittle
- broken glass is hazardous
- certain glasses release alkali into the content
what is glass type 1?
- borosilicate glass made by adding boric oxide
- most inert with high hydrolytic and thermal resistance
what is a disadvantage to using type 1 glass?
-most expensive glass to produce
what is type 1 glass more commonly used for?
to pack fluids for injections
what is glass type 2?
- made from soda-lime-silica
- has moderate hydrolytic resistance
how can we improve the hydrolytic resistance of type 2 glass?
treating inner surface with sulphur dioxide
what is type 2 glass more commonly used for?
- packing aqueous preparations for the eye
- or used for other dropper bottles
what is glass type 3?
-made from soda-lime-silica
what is the difference between glass type 2 and 3?
-type 2 contains more alkaline metal oxides whilst type 3 has less oxides
what is type 3 glass more commonly used for?
-non-parenteral preparations and powders for injections (not suitable for aqueous preparations)
what are thermoplasts?
plastics that are mouldable by temperature
what are thermosets?
plastics that are not mouldable by temperature
why are plastics the most common materials used for packaging?
–Light and shatterproof
–Can be clear or opaque
–Easily shaped and sealed, allows inclusion of administration aids e.g. squeezable dropper.
–Cheap
–Greater versatility, suitable for use as container, closure and as secondary packaging.
plastics are made up of at least one polymer and additives. what are these additives?
- plasticisers
- resins,
- stabilisers,
- lubricants,
- antistatic agents,
- module-release agents.
what are disadvantages to using plastics as packaging?
- Chemical inertness and impermeability is lower compared to Type I glass.
- Less resistant to heat and long-term exposure of light than glass and metal.
- Liable to undergo stress cracking: where solvents can cause plastic pack to become brittle.
- Plastic component may leach into the content.
Metals can corrode due to interaction with water and oxidation. What is done to prevent this in packaging?
-the metal packaging is lined with a protective varnish
what metals are normally used?
- aluminium
- tin-plated steel
- stainless steel
- tin
- lead
what are most metals commonly used for?
to package meds for non-parenteral administration
what are the advantages to using metal packaging?
- Mechanically strong, e.g. can withstand high internal pressure.
- Shatterproof
- Lightweight
- Impermeable to light, moisture and gases
- Can be tailored in hardness and flexibility
- Malleable (particularly useful to produce collapsible tubes, metal collar on vials).
what are the disadvantages to using metal packaging?
- more expensive
2. react with pharmaceutical product (so they require coating)
what are the rubber packaging used for?
closure/stoppers fro vials, fluid bottles and dropper bottles
what are advantages to using rubber packaging for closure?
- when used for parenteral containers, they allow a needle through and then they reseal when the needle is removes
- they’re soft enough to mould into a desired shape to form a tight seal
what are the disadvantages to using rubber packaging?
- they aren’t inert
- may leach residues into the content as they’re permeable to some extent.
paper isn’t used as a primary packaging true or false?
true except for sachet
what are advantages to using paper packaging?
- relatively low cost
- non-toxic
- recyclable
- can be folded up
- easily printed and coated
- rigid enough to be used as cartons.
what are disadvantages to using paper packaging?
- has no barrier properties against moisture, gases and odours
- has poor transparency
- require adhesives or special coating
