Packaging Flashcards
Role of pharmaceutical packs
-Protection
+Climate, biological, physical and chemical hazards
-Identification and information- Drug name, strength, form, contraindications, excipients
-Patient compliance, convenience and administration- no child saftey lock with RA; calendar packs; devices (inhalers, spacers, syringes)
-Presentation
-Containment
-Economical
Protective function
- Physical and mechanical hazards
- Climatic or environmental
- Biological
- Chemical
Physical or mechanical
- Shock
- Impact
- Vibration
- Abrasion
- Puncture
Primary and secondary packaging
-Primary= in direct contact with the drug formulation
+blister packs, glass bottles
-Secondary= around the primary containers
+Spacer, cardboard boxs
Shock or impact
-Rough handling \+Dropping -Compression- stacking in storage and transport -Reducing risk by \+Cushioning \+Restricting of pack movement \+Careful handling
Vibration and abrasion
-Frequency and amplitude
+Truck- high amplitude (How far it moves) and low frequency (How often it moves)
+Planes and boats- low amplitude and high frequency
-Loosen closures- liquid based dosage forms
-Abrade labels and decoration- obscure labels
-Compact powders- lead to caking or compaction of powder
Puncture
- Opening boxes of IV fluids
- Fork lift tructs
Climatic and environmental
- Moisture
- Temperature
- Pressure
- Light
- Atmospheric Gases
Climate
- Arctic, antarctic, temperate, sub-tropical and tropical
- Deep freezes and fridges- -19 to 22’C
- Bathrooms and kitches (high humidity and temperature)
- Product display areas under high wattage bulbs
- Product storage areas near pipes or heaters in shop or warehouse
How do we determine shelf life
-Subject to extreme conditions-
+High heat (Accelerated stability conditions 40’C and 75%)
+High Moisture (humidity)
-Accelerated stability conditions 40’C and 75% humidity for 6 months
-Long term stability conditions- store at 25’C at 60-65% Humidity for 12 months
+Why choose these conditions- the geographical variations across the world- this is a pretty good representation of conditions across the globe
-NB- you have to have the drug product in the final packaging form that the drug will have (i.e. plastic or glass bottles)- this is done
Moisture
-Liquid and water vapour may cause
+Physical changes (softening or hardening of powders to tablets)
+CHemical changes (Hydrolyis , effervescence
-All plastics are permeable to moisture to some extent
-Even screw closures are likely
to permit some moisture entry
-Fast melts, Oral Disintegrating tablets (calpol, imodium, buprenorphine)- come in specialist packaging, this is because they are highly moisture sensitive- this is completely impermeable to moisture
Temperature
-Extremes and cycling of temperature can cause deterioration in the product and pack
+Certain plastics become brittle at low temperature
+High temperatures and humidity can produce a ‘shower effect’ if temperature lowered to dew point (when temp is lowered droplets can form)- compramised stability
+Mould and bacterial growth
Light
-Can cause discoloration and fading of printed or decorated packaging
-Can be seen as inferring change in product efficiency or strength
+Effect consumer psychology and confidence
-Possible solutions
+Metal foils to exclude light
+UV absorbers added to plastic
Atmospheric gases
-Oxygen- can cause oxidation of the pharmaceuticals
-Carbon Dioxide- can cause pH shift (e.g. unbuffered solutions in LPTE bottles which are permeable to CO2)
-Relative permeability of gasses in plastics
+CO2>O2>N2 (20:4:1)
Biological hazards
-Microbiological
+General move toward improved Microbiological control far all pharmaceutical products
-Sterile products
+Pack and colsure must maintain 100% effective seal against microbiological ingress (bacteria, mould and yeasts)
-Infestation
+By insects, birds and rodents
-Pilferage
+Need for tamper proof packs and security seals
+Increase consumer confidence in the product
