packaging... Flashcards
whats Primary packaging?
Directly in contact with product
Primary packaging requirements?
- compatible with content and protection form hazards
- Consider incompatibility: nothing leaving product/ entering and affecting packaging/product
- Provide info on content: bar code, expiry date, batch num etc
- Ideally be child-resistant but easy to open and re-seal by patient
- Be tamper-resistant/ offer proof of tampering
- Be fit for purpose i.e. blister packs for tablets but not for semi-solids
how many types of packaging? (stages)
primary
secondary
tertiary
3
Secondary packaging Containment. role?
- Added layer of protection from light etc.
- Get more info on product- dose, use, image- important for patient to ensure correct content. May be bottle/box
- Dispensing label also provided.
e.g. pill boxes
requirements for packaging in general?
should
• NOT leak
• NOT allow diffusion/permeation of product vice versa
• BE strong enough during all steps of handling, storage, transport, use
• NOT be altered by the formulation it contains.= may not be fit fr purpose during shelf life
what do you want to maintain w pharm product?
quality, safety, stability of pharmaceutical product throughout shelf lfie
4 types of hazards?
mechanical: shock/impact
chemical: adsorption/ loss of volatiles/ leaching
biological: contamination
climatic: tesmp, moisture, pressure
Identification, Presentation and information
- Additional roles of packaging
- essential source of information on medicinal products.
- Info leaflet still part of packaging
what information is added on packaging?
- Product name
- Type of product
- Quantity / strength / BN
- Mode of administration
- Date of manufacture
- Shelf-life / expiry / date
- Storage instructions
- Contraindications / precautions
- MA / ML numbers
- Legal classification
- Manufacturer’s name / address
- Bar code
- Warnings (i.e. KOOROC)
- Formulation details (i.e. Ingredients)
i.e. on pill box
Risks due to similar looking packaging
could be same drug, different doses/ different salts of same drug/ different drug but similar packaging.
Very confusing for patient and carer to distinguish
types of Containers for primary packaging
Can be multiple at same time, need to be most appropriate for product and use
single / multi dose airtight sealed tamper evident well closed child resistant
characteristics of tablet bottles
o Made of glass or plastic
o Amber-coloured
o Child-resistant cap
types of medicine bottles?
o Amber-coloured bottle
o Fluted amber bottle
Child resistant cap
o Dropper bottle
Single dose containers e.g:
- Glass ampoules
- Infusion bags
- Single-dose syringes
- Nebuliser ampoules
- Don’t need preservatives
Multi dose containers
- Multi-dose vials for injectables
- Multi-dose glass/plastic bottle.
- Pressurised metered dose inhalers
- Dry powder inhalers
- Cream jar/bottle/tube (semi-solids)
role of Light Resistant Containers?
- Protect the contents from the effects of UV radiation at a wavelength between 290 nm and 450 nm.
- For example amber bottles
what are Sealed containers and give examples
i.e. closure and container form same unit
sealed during packaging and cant be resealed once used
Prevents product from contaminants such as air or moisture. e.g.
• Ampoules
• Aluminium bags
• Plastic eye-drops
Laminates from foil and films
Used for …
suppositories, sachets, Blister packs: • Tray with lid used as packaging for tablets and capsules • Provides hermetic seal • Good barrier properties • Metal (excellent barrier) • Plastic (coated PVC) • Tamper-evident- packaging damaged with tablet removal
Unit dose packaging- strips use?
- In the Strip packaging, the tables or capsules are sealed between two same materials, such as aluminium foil, heat sealed.
- This packaging protects the tablets/capsules from environment
Tubes and jars types?
Collapsible tubes for semi-solids
Ointment jars
2 forms of Collapsible tubes for semi-solids
Lacquered aluminium
Sealed at both end
Pierce to use
LDPE/HDPE/PP
Can be heat sealed
Made of plastic with layer of foil that must be removed
Ointment jars
Wide-mouthed
Semi-solid preparations
Risk of contamination by patient
Repackaging- what req must be met
benefits?
• Patient can access all the information about the product
• Less time-consuming: so more time for counselling
• Lower risk of errors or cross-contamination
From bulk bottle:
number of capsules/tablets counted and transferred to bottle.
Compliance aid problems
higher risk of error
• Less info to patient
• May be cross-contaminations/ incompatibilities with meds. Stability affected compared to original packaging.
• If meds stopped- right product removed from this. Legal issues to- removal into compliance aids
Other options to aid compliance and help patient remember dose.
Date/ scratch label on blister pack: good for 1 med a day