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PH2503- formulations > Packaging 2 > Flashcards

Packaging 2 Flashcards

1
Q

Plastics and polymers

A
  • Types
  • Advantages
  • Disadvantages
  • Other possible negative factors
  • Stability profiles of injections in plastic
  • Additives
  • Residues, additives and process aids
  • Fabrication process
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2
Q

Thermoplastics

A

-Soften on heating to a viscous fluid and harded on cooling
-Mould into different shapes and thickness
-Autoclavable (for injection)
+High density polyethylene (HDPE)- poor visual clarity
+Polyvinylchloride (PVC)-Poor flexibility; plasticisers have to be added to form infusion bags
+Polypropylene (PP)- Higher heat resistance than PE
NB- we place additives to plastics to tailor the plastics to what we need for pharmaceutics

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3
Q

Other plastic types

A 
-Polystyrene (PS) 
\+General purpose and impact modified 
\+Tablet bottles for dispensing 
-Polytetrafluoroethylene (PTFE) 
\+High chemical resistance 
\+Very expensive 
\+Coatings or liners 
-Polyester (PET) 
\+Increasingly popular for oral liquids 
\+Inert 
\+Lower temp resistance
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4
Q

Plastics- advantages

A

-large material choice
-Broad range of physical and chemical properties
-Large number of fabricaion process
-Range of decorative and printing options
-Numerous design option
+Simple squeezable bottles for eye medications
+Complex valve systems for MDI’s
-Clean process
-Light and robust

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5
Q

Plastics- disadvantages

A
  • Possible extraction of chemical adatives from the plastic- PVC plasticisers
  • Interaction with medication- Diazepam absorbed onto PVC
  • Absorption of components of the pharmaceutical formulations
  • Lightweight
  • All plastics p-ermeable to some extenbt to moisture, oxygen and CO2
  • Most plastics build up electrostatic charge
  • Transmit light unless pigmented
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6
Q

Plastic disadvantages (2)

A

-Stress cracking
+Caused in LDPE by certain agents- detergents and volatile oils
-Surface crazing
+Fine-scales cracking especially in PS caused by exposure of amorphous plastics to certain chemicals
-Poor printability
+Polyolefins in PE and PP require pre-treatment to enable ink to ‘key’ to surface
-Additives in plastics can migrate to the surface interfering with printing

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7
Q

Plastic disadvantages (3)

A

-Poor impact resistance with PS and PVC
+Can be improved in conclusion of impact modifiers e.g. rubber
+BUT permeability of plastic increased
-Gamma irradiation of LDPE
+Induces cross-linking and leads to brittlesness
-Negative aspects of plastics for pharmaceutical packaging can be overcome or minimised by suitable design
+Loss of preservatives from by dissolution in LDPE can be reduced by enclosing bottle in PVC blister pack
+PVC impermeable to volatilised preservatives
+Equilibrium of volatile preservative forms in air space between formulation, bottle and pack air space

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8
Q

Stability profiles of injections in plastics (1)

A

Simulate in use conditions and examine for
-Sensory, chemical and physical changes
-Changes in weight or volume- Plastic permeability
-pH changes
-Effects of light
-Effect of extractables on the injection
+Plasticiser from PVC bags detected in IV fluid

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9
Q

Stability profiles of injections in plastics (2)

A

-Permeability of gases and solvent vapours through plastic into injection- (overall stability of drug product)
+Cyclohexane- solvent for PVC- extracted from infusion bags
-Absorption of active, bactericides and other components- Drug absorption - diazepam on PVC

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10
Q

Plastic additives

A
  • Polymer
  • Residues associated with polymerisation
  • Additives used to modify properties
  • Process aids
  • Knowledge of constituents of plastic essentials; may be extracted from plastic into medication
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11
Q

Residues, additives and process aids

-Residues-

A
  • Monomer (haven’t undergone polymerisation)
  • Catlysts
  • Accelerators-
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12
Q

Additives- property modifier

A
  • Fillers
  • Anti-static agents- minimise static forces
  • Anti-oxidants
  • Plasticisers- soften plastic that are robust by aligning themselfs between polymer chains
  • Pigment /dyes-UV stability
  • Whitners/opacifiers
  • UV absorbers
  • Flame retardants
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13
Q

Process aids

A
  • Solvents
  • Release agents
  • Emulsifiers
  • Lubricants
  • Stabilisers
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14
Q

Plastic fabrication process

A

-Options far greater than glass
+Injection moulding- Molten material injected into mould, to control appiture size
+Blowing moulding- Air used to drive molten plastic into mould
+Thermoforming- vacuum forming
+Extrusion
+Solid phase pressure forming
-Basic moulding operations
+Plastic heated to melt or softern material
+Material shaped in a mould
+Cooling to solidify plastic

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15
Q

New Plastic IV Bags

A

-Multi-layer, co-extruded polyolefine (Printing on packaging is difficult) based material with inert polyerthylene layer in contact with solution
+This means sterility wont be compramised
-Polypropylene/ polyamide over wrap

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16
Q

Metal and metal containers (1)

A

-Metals widely used for 10-29 years for rigid containers
+Tablets, capsules, powders and liquids
-Example products
+Collapsible stubes (eye ointment or cream)
+Al tin or tin coated lead
+Manufactured by impact extrusion
+Replaced by plastic
NB- ODT- Al covered container prevents moisture uptake

17
Q

Metal and metal containers (2)

A

Modern applications
-Mainly Al and its alloys
-Foils
+Facings for wadded closures
+Pressurised containers- aerosols including MDI’s
+Closures: particularly ROPP (Rolled on Pilfer Proof); Important for security and tamper evidence

18
Q

Paper and board

A

-Remains a significant part of 2ndary pharmaceutical packaging- Labels, cartons, bags, information, skrink wrap trays
-Cartons traditionally used for high % of pharmaceutical products
+Increase product display area
+Improve stacking
+Physical protectio - collapsible tubes
+Information- inside and out
+Protection from light
+Compliance= recognition

19
Q

Films, foils laminates

A

-End uses
+Sachets, bottle seals, strip packs, blister packs, liners, over-wraps
-Blister packs
+Lid- board, paper, foil, coated film
+Thermoformed tray: PS, PVC, PET, Foil, PE, Or a combo
+Push through systems- lid firmly bounded to the tray
+Peelable system- lid easily pulled back
+Foil blisters or foil overwrap- provides a hermetic pack- excludes virtually exchange of gases between product and surroundings

20
Q

Closures

A

-Essential part of primary and secondary pack
-Possible functions
+Totally hermetic seal- fused glass ampoule; No exchange occurs between contents and outside environment
+Microbial seal- Rubber bung with metal over-seal
+Effective seal- Adequate for the product, closure not hermetic nor a total guarantee against entry of bacteria

21
Q

Rubber Closure

A

-Ideal properties and requirements
+Good aging properties and oxidation resistance
+Hardness and elasticity should allow neeedle to pass through without blunting
+Puncture should close immediately on withdrawing needle (vials of drugs)
+No change in properties during steralisation
+Impermeable to air and moisture- Penicillin is water sensitive

22
Q

Closure types (1)

A
  • 2 main types of closure: Physical compression; Heat sealing
    1) Plug in: friction or push in (Rubber closure for injections/ampules)
    2) Push-Over or ‘Snap-fit’ (e.g. LDPE)- Bead at opening of container CHILD PROOF LIDS
    3) Screw cap (Al PE, PP)
    4) Rolled on (RO) Al alloy caps
  • Rolled on pilfer proof (ROPP) Al alloy caps
  • Popular for security of export products
  • Contact lens solution bottles
23
Q

Natural rubber composition

A

-

24
Q

Synthetic rubber

4 main types used in pharmaceuticals

A

1)Butyl Rubber
-Resistant to chemical attack and ageing
-Poor oil and solvent resistance
2) Nitrile rubber
-Good oil and heat resistance
-Major absorption of bactericides
-Leaching of extratives is high
3)Chloroprene rubber
-Resistant to oxidation and oils
-Low water permeability
4)Silicone rubber
-Heat resistant
-Low water permeability
-Expensive
NB More resistant to high temperature and ageing than natural rubber and latex free BUT more expensive

25
Q

Pharmaceutical problems (1)

A

1)Components of injection can be extracted by rubber
-Bactericide absorption
+Chlorocersol and phenyl mercuric nitrate strongly attracted to and absorbed by rubber
+Treat closures in solutions containing bactericides- Twice concentration of product solution
-Volatilisation of bactericide from closure after equilibrium attained
+Loss limited by: Sealing closure with less permeable material such as paraffin
_Reduction of upper surface area
_Increase closure thickness

26
Q

Pharmaceutical problems (2)

A

-Reduction of anti-oxidant activity
+Sodium metabisulphite or sulphur dioxide can be absorbed from injection solutions can help stop oxidation
-Particulate contamination by rubber coring during withdrawal of dose
-Rubber is to extent, permeable to moisture and gasses- seal may not be strictly hermetic

27
Q

Rubber closures for injection

A
  • Greater emphasis must be placed on packaging material and effects of sterilisation process
  • Many ways to steralise: Dry heat; steam; Ethylene oxide; gamma-radiation
28
Q

Rubber closure for injection

GLASS

A
  • Dry Heat (DH)= YES
  • Steam (S) = YES
  • Ethylene Oxide (Et O)= Yes- degassing is essential to remove TOXIC residues of EtO, Et glycol (hydrolysed EtO), epichlorhydrin (if CL- ions present)
  • Gamma-radiation (G-r)= NO- discoloured
29
Q

Rubber closure for injection

RUBBER

A
  • DH= NO- rubber generally will not withstand dry heat (Silicone rubber)
  • S= YES
  • EtO-degassing is essential to remove TOXIC residues of EtO, Et glycol (hydrolysed EtO), epichlorhydrin (if CL- ions present)
  • G-r= YES- unacceptable physical and chemical changes can occur by molecular cross-linking
30
Q

Rubber for injections

PLASTICS

A
  • DH=NO- Only suitable for few plastics
  • S=YES
  • EtO= YES-degassing is essential to remove TOXIC residues of EtO, Et glycol (hydrolysed EtO), epichlorhydrin (if CL- ions present)
  • G-r= YES-unacceptable physical and chemical changes can occur by molecular cross-linking

PH2503- formulations (18 decks)

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