Packaging Flashcards
Roles of packaging
Containment of product - leakage
Protection of product quality and potency - moisture, light
Presentation - brand identification
Compliance - packaging allow easy product administration
Patient protection - accidental poisoning
Detection of counterfeit - QR/hologram
Tamper proofing incident example
Tylenol 1982
Was spiked with cyanide leading to 7 deaths
Tamper proofing
Primary - Foil seals on creams and seals on bottles under cap or plastic seals on cap like mouthwash
Secondary - seals on boxes
Packaging levels
Primary - direct contact with product ie bottle, sachet, blister strips
Secondary - packaging that surrounds primary ie box that tablets come in
Tertiary - allow bulk handling ie large containers
(Tablet strip goes in a box that is delivered in a larger box)
Packaging component - Closures
Screw caps, child proof screw caps, tube caps, vial flip caps, enema applicator, vaginal applicator, dosing syringe
Packaging component - desiccants
Used in bottles to absorb moisture
Generally silica gel capsules
Warning not to swallow
Packaging component - leaflet
Printed document to provide essential information for patients about the use of medications
Packaging components - boxes
Tablet cardboard box - 2ndary
Carton box - tertiary
Labelling - includes….
Name of medicine
Strength
Dosage and route of admin
Dose
Indication
Manufacturing details
Warnings
Ideal packaging materials
Sufficient mechanical strength - withstand handling and transport
Elegant and easy t handle shape
Be chemically inert - no leak or absorb chemicals
Non toxic and chemically stable
Not impart tastes or odours to product
Reasonable cost
For sterile formulations should be stable during sterilisation
Types of packaging materials
Glass -> type I, type II, type III, type IV
Plastic -> polyethylene, polypropylene, polystyrene, polycarbonate
Metals -> aluminium, iron, tin, lead
Rubber -> butyl rubber, silicone rubber, natural rubber
Glass + adv&disadv
Composed of sand, soda ash and lime stone
Advantages:
i. Relatively chemically inert.
ii. Strong and rigid.
iii. Easy to clean and sterilise.
iv. Transparent glass enables easy visual inspection.
v. Coloured (red or amber) provides light protection for photolabile products.
vi. Impermeable.
Disadvantages:
I. Heavy.
II. Fragile.
III. Some types release alkali into aqueous products.
Type I glass composition, properties and uses
Borosilicate glass
SiO2 - 80%
• Has high melting point socan withstand high temperature
• Resistant to chemical substances
• Reduced leaching action.
• Reusable.
• Laboratory glass apparatus
• For injections.
• for water for Injection.
Type II glass composition, properties and uses
Treated side-lime glass
Made of soda lime glass. The surface of which is treated
with acidic gas like SO2 (i.e. dealkalised) at elevated
temperature (500°C) and moisture.
• Sulfur treatment neutralizes the alkaline oxides on the surface, thereby rendering the glass more chemically resistant.
• Used for alkali sensitive products.
• Infusion fluids, blood & plasma.
• large volume container
Type III glass composition, properties and uses
Regular soda-lime glass
SiO2, Na2O, CaO
• It contains high concentration of alkaline oxides and imparts alkalinity to aqueous substances
• May crack due to sudden change of temperature.
• For oily parenteral.
• Not for aqueous parenteral.
• Not for alkali- sensitive drugs.
Type IV glass composition, properties and uses
Non-parenteral glass or general purpose soda lime glass
• General purpose.
• For oral and topical.
• Not for parenteral.
What are Plastics
A group of synthetic polymers of high molecular weight
Polymer vs copolymer
A-A-A-A-A-A-A-A-A -> repeated small units
A-B-A-B-A-B-A-B OR A-A-A-B-B-B -> copolymer
What determines the physicochemical properties of the formed polymer
Chemical composition of monomer, arrangements of polymerisation, number of monomers
Linear chain
Closely packed
High density polymer
Branched chain
Loosely packed
Lower density polymer
The more monomer repetition …….
high molecular weight polymer → high glass transition temperature
𝑇 𝑔 and melting point 𝑇 𝑚 → the more rigid the plastic is.
Physical properties of plastic
They are sensitive to heat, and many may melt or soften at or below 100°C.
Light and easy to handle
Almost as strong as metals
Poor conductor of heat
Generally resistant to inorganic materials but often attacked by organic solvents and oils
Plastic additives
May contaminate the content:
o Antioxidants: prevent polymer oxidation.
o Lubricants : prevent plastic-mould adhesion.
o Plasticiser : to lower 𝑇 𝑔 making it easy to shape.
o Pigments : for colouration.
Adv&disadv of plastics
Advantages of plastics
1. Cheap.
2. Good mechanical properties, robust.
3. Ease of manufacturing.
4. Some polymers have good film forming properties.
5. Could be child-resistant.
6. Could be heat sealed.
7. Light weight.
Disadvantages of plastics
1. Not as inert as type I glass
2. Quite permeable to moisture and O2 → bad for sensitive drugs
3. Some plastics undergo stress cracking.
4. Heat-sensitive.
5. May hold electrostatic charge.
6. Leakage of plastic additives.
7. Can adsorb some drugs and excipients.
8. Not biodegradable. → Recycling or Disposal ?
Plastic recycling
PETE - polyethylene, consmetic continers and plastic bottles
HDPE - high density polyethylene, detergent bottles, milk bottles
V - polyvinyl, blood bags and blister packs
LDPE- low density polyethylene, cling film
PP - polypropylene, bottle caps and straws
PS - polystyrene, foam packaging
OTHER - polycarbonate, Tupperware and baby bottles
Biodegradable polymers
Type of polymers, or large molecule, that can break down naturally through bacterial decomposition into natural byproducts such as gases (CO2), water, biomass, and
inorganic salts.
• Environmentally friendly.
• From natural (biopolymers) and synthetic origin.
Biodegradable polymers examples
o Starch→ derived from corn.
o Amylopectin → highly branched polysaccharide.
o Amylose → linear polysaccharide.
o Chitosan → derived from crustaceans.
o Poly(caprolactone) → synthetic but biodegradable.
Adv&disadv of biodegradable polymers
Advantages
- Compostable.
- Made from rapidly renewable sources.
- Production does not involve harmful chemical to humans.
- Could have good thermal and mechanical properties.
Disadvantages
- Expensive.
- Poor gas and water barrier properties.
- Limited stability.
Metals
Used solely for medicinal products for non-parenteral admin
Include tubes, aerosols and gas cyinders
Ideal for pressurised containers as impermeable to gasses and shatterproof
Different metal adv and disadv
Aluminum
- light and inexpensive, forms thin oxide layer upon oxidation for protection against further oxidation
* reacts at low and high pHs and upon corrosions H2 is evolved
Tin
- chemical resistant and used as coat for other metals
*most expensive
Iron
- used as tin coated steel
*tin coated peeling results in tin corrosion
Lead
- lowest cost and soft
*risk of lead poisoning so always have an internal lining of inert metal or polymer
Rubber/elastomer
Primarily used as closures on parenteral containers
Permit needle to enter container
Ability to resist fragmentation when penetrated by needle
Solvent resistance
Radiation resistance
Gas and moisture impermeability
80% of parenteral closures are?
Butyl and chlorobutyl rubber
Consideration of the choice of packaging materials
Permeability
Leading
Abrogation
Light protection
Chemical reactivity
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