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Hypertension > Packaging > Flashcards

Packaging Flashcards

1
Q

Roles of packaging

A

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

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2
Q

Tamper proofing incident example

A

Tylenol 1982
Was spiked with cyanide leading to 7 deaths

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3
Q

Tamper proofing

A

Primary - Foil seals on creams and seals on bottles under cap or plastic seals on cap like mouthwash
Secondary - seals on boxes

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4
Q

Packaging levels

A

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)

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5
Q

Packaging component - Closures

A

Screw caps, child proof screw caps, tube caps, vial flip caps, enema applicator, vaginal applicator, dosing syringe

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6
Q

Packaging component - desiccants

A

Used in bottles to absorb moisture

Generally silica gel capsules

Warning not to swallow

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7
Q

Packaging component - leaflet

A

Printed document to provide essential information for patients about the use of medications

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8
Q

Packaging components - boxes

A

Tablet cardboard box - 2ndary

Carton box - tertiary

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9
Q

Labelling - includes….

A

Name of medicine
Strength
Dosage and route of admin
Dose
Indication
Manufacturing details
Warnings

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10
Q

Ideal packaging materials

A

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

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11
Q

Types of packaging materials

A

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

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12
Q

Glass + adv&disadv

A

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.

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13
Q

Type I glass composition, properties and uses

A

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.

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14
Q

Type II glass composition, properties and uses

A

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

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15
Q

Type III glass composition, properties and uses

A

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.

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16
Q

Type IV glass composition, properties and uses

A

Non-parenteral glass or general purpose soda lime glass

• General purpose.
• For oral and topical.
• Not for parenteral.

17
Q

What are Plastics

A

A group of synthetic polymers of high molecular weight

18
Q

Polymer vs copolymer

A

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

19
Q

What determines the physicochemical properties of the formed polymer

A

Chemical composition of monomer, arrangements of polymerisation, number of monomers

20
Q

Linear chain

A

Closely packed

High density polymer

21
Q

Branched chain

A

Loosely packed

Lower density polymer

22
Q

The more monomer repetition …….

A

high molecular weight polymer → high glass transition temperature
𝑇 𝑔 and melting point 𝑇 𝑚 → the more rigid the plastic is.

23
Q

Physical properties of plastic

A

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

24
Q

Plastic additives

A

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.

25
Q

Adv&disadv of plastics

A

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 ?

26
Q

Plastic recycling

A

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

27
Q

Biodegradable polymers

A

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.

28
Q

Biodegradable polymers examples

A

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.

29
Q

Adv&disadv of biodegradable polymers

A

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.

30
Q

Metals

A

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

31
Q

Different metal adv and disadv

A

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

32
Q

Rubber/elastomer

A

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

33
Q

80% of parenteral closures are?

A

Butyl and chlorobutyl rubber

34
Q

Consideration of the choice of packaging materials

A

Permeability
Leading
Abrogation
Light protection
Chemical reactivity

35
Q

Jjbbo

A

Hypertension (24 decks)

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