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SOM 2 > packaging and assessment > Flashcards

packaging and assessment Flashcards

1
Q

how is pharmaceutical quality measured and what is it affected by?

A 
affected by:
- starting materials
- manufacturing process
- packaging and transport
- storaging 
measured by:
- physical and chemical analysis
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2
Q

what does microbiological quality depend on?

A
  • bioburden
  • bacterial endotoxins
  • pyrogens
  • sterility
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3
Q

what is a special/unlicensed medicine?

A

manufactured for human use and has been specially prepared to meet a prescription ordered for individual patients without need to hold a marketing authorisation for the product

  • can be supplied for individual patients need
  • need a mnaufacturer’s special license
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4
Q

what is the aim of bioequivalence?

A

to determine if two pharmaceutical products demonstrate in vivo biological equivalence

  • generic medicines must prove bioequivalence
  • allows patient compliance and reassure them they have the same product and effect
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5
Q

how can we establish bioequivalence?

A

use the PK parameters

  • plasma conc. vs time curves
  • Cmax and Tmax
  • look at the ADME phases
  • Tmax shouldn’t be first sampling point

take blood samples at specific points and with equal time intervals
need to see if its single dose or multi dose; if multi must add more sampling points
want to see full picture of drug exposure

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6
Q

what is the acceptance range for different AUC and Cmax ratio?

A

AUC should lie within 90% confidence interval; 0.8-1.25 of the reference value
Cmax ratio should lie within 90% confidence interval; 0.8-1.25 of the reference value
- can be tighter for drugs with narrow therapeutic window

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7
Q

what does it mean by specification and how are these set?

A

a specification is defined as a list of tests, references to analytical procedures and appropriate acceptance criteria

  • set to confirm the quality of a drug product
  • focus on making drug effective and safe
  • need relevant data
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8
Q

what should development of a pharmaceutical product include?

A

should include the definition of the quality target product profile
should have identification of the critical quality attributes
a control strategy for insurance and ensure product is fit for use
should have a selection of manufacturing processes

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9
Q

what does quality by design mean, require and ensure?

A

it means that design a formulation that ensures the product has met the pre-defined standards
requires understanding how formulation and manufacturing process influences product quality
it ensures good quality with a good control strategy

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10
Q

what is a quality target product profile?

A

it is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality

must consider

  • closures
  • dose strength
  • drug release and delivery
  • intended use, dosage form, route
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11
Q

what is meant by CQA?

A

critical quality attributes is a physical, chemical or microbiological property that should be within an appropriate limit range or distribution to ensure good product quality
- can be defined for drug substances, drug products and excipients and intermediates

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12
Q

what is a CPP?

A

Critical Process Parameter is a a parameter whose variability has an effect on CQA and so should be monitored or controlled to ensure good quality

e. g for tablets CPPs could include:
- mixing
- granulation
- drying
- compression
- coating

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13
Q

for a simple immediate release tablet what must the analytical measurements be?

A

must be

  • linear
  • accurate
  • repeatable
  • reproducible
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14
Q

what is the dissolution specification?

A

75% dissolved in 30 minutes

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15
Q

what is primary packaging?

A
  • direct contact with the product
    must be
    1. compatible with product
    2. have all product info
    3. be child resistant but easy to open and re-seal
    4. be tamper-resistant or tamper-evident
    5. fit for purpose
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16
Q

what is secondary packaging?

A
  • added layer of protection
  • information provided
  • image of what medication looks like
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17
Q

what is packaging used for and why?

A
  1. containment
    - shouldnt leak
    - no diffusion of product
    - be strong during handling
  2. protection
    - maintain quality, safety and stability of product through its shelf life
  3. identification, presentation and information
    - not direct contact
    - essential source of information
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18
Q

what type of bottle packaging can you have?

A
  1. Tablet bottles
    - made of glass or plastic
    - amber coloured
    - child resistant cap
  2. medicine bottles
    - amber coloured bottle
    - fluted amber bottle
    - dropper bottle
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19
Q

what are examples of single dose and multi dose containers?

A 
single dose 
- glass ampoules 
- infusion bags 
- single dose syringes 
- nebuliser ampoules 
multi dose 
- multi dose vials or glass bottles 
- pMDI's 
- cream jar/bottle/tube 
- DPI's
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20
Q

what do sealed containers do?t

A
  • prevents product from contaminants such as air or moisture
  • a single unit with our preparation
  • once opened it is unsealable
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21
Q

what are laminates?

A

two bits of metal that you put together

paper outside for printing info on

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22
Q

what are blister packs?

A
  • tray with lid used as packaging for tablets and capsules
  • provides hermetic seal
  • good barrier properties
  • tamper-evident
23
Q

what does strip packaging look like?

A

the tablets or capsules are heat sealed between two same materials, such as aluminium
protects drug from environment

24
Q

what are collapsible tubes and ointment jars?

A 
collapsible tubes:
- lacquered aluminium and is sealed at both end 
- can be heat sealed 
- layer of foil when first opened so needs to be removed for access 
ointment jars:
- wide mouthed 
- semi solid preparation 
- risk of contamination by patient
25
Q

what are risk errors for repackaging?

A
  • right drug
  • right number given
  • right strength so more checks
26
Q

what is glass made of? what additives are there?

A
  • silica
  • limestone
  • soda ash
  • cullet

additives

  • hardness
  • heat - shock resistance
  • opacity/clarity
  • colour
27
Q

what are dis/advantages of glass being a packaging?

A

+ inert and impervious to air and moisture
+ protects from loss of volatiles
+ easy inspection of content
+ can be tinted to block harmful light rays
+ easy to clean and sterilise by heat
- brittleness can release glass fragments
- release of alkaline compounds
- cost and weight
- leaching of glass components

28
Q

what types of glass is there?

A

Type I
- borosilicate glass - low leaching risk and less likely to shatter
- low coefficient of thermal expansion ; good for heat sterilisation
- is costy
e.g. ampoules, injection vials
Type II and III glass
- treated soda lime glass for Type II
- soda lime glass similar to food packaging for Type III

29
Q

what are the uses of Type II and III glass?

A 
Type II 
- aqueous solutions 
Type III
- non-aqueous parental products 
- powder for injection
30
Q

what uses does plastic have?

A
  • packaging of tablets, capsules
  • for eye drops or nasal sprays
  • as jars or flexible tubes
  • blister or strips pack
  • infusion bags and for the packaging of SVPs
  • as closures for bottles
31
Q

what do typical plastic containers contain?

A
  • polymers
  • polymerisation residues ; impurities
  • additives added to modify the properties of the plastic
  • processing aids
32
Q

what is the difference between thermoplastics and thermosetting plastics?

A

thermoplastics
- can be remoulded and heated more than once
- when it is heated its melt and when it is cooled it hardens
- it is free polymer chains
thermosetting plastics
- can only be heated and moulded once

33
Q

what plastic additives are there?

A
  • colouring agents
  • stabilisers
  • UV absorbers
  • lubricants
  • plasticisers
  • flame retardants
  • antioxidants
34
Q

what are the advantages of plastic?

A
  • low cost
  • low particle release
  • light in weight
  • heat sealable
  • easily moulded
  • multipurpose
  • not as inert as Type I glass
35
Q

what are the disadvantages of plastic?

A
  • has electrostatic charge
  • leaching of additives can occur
  • adsorption; loss of preservative
  • poor barrier properties; to sun rays and gas
36
Q

what is poly(ethylene)?

A

PE

  • has poor odour barrier
  • good compatibility with drugs overall but can sorb preservatives
  • low density polyethylene LDPE
  • > clear & flexible
  • high density polyethylene
  • > strong rigid translucent
  • > can be pigmented
37
Q

what is poly(propylene)?

A
  • clear strong and rigid
  • heat resistant and excellent barrier to moisture
  • good resistance to cracking when bent
  • > lower amount of additives and lower risk of adsorption
38
Q

what is poly(vinyl chloride)?

A
  • variable rigidity, clear and glossy
  • heat sensitive
  • poor impact resistance
  • resistant to oils, fats and flavouring
  • need more additives
  • not good at protecting against mechanical hazards
39
Q

what is poly(vinylidene chloride)?

A
  • provides best barrier to moisture gases
  • heat resistant
  • clear
  • flexible
  • excellent barrier properties
40
Q

what is poly(chlorotrifluoroethylene)?

A
  • clear plastic
  • heat resistant
  • excellent barrier properties
41
Q

what is poly(styrene)?

A
  • Crystal PS; clear strong rigid but brittle
  • poor impact resistance
  • poor barrier to moisture, gases and poor chemical resistance
  • good for general purpose use
  • insufficient heat resistance to resist autoclaving
42
Q

what is poly(ethylene terephthalate)?

A
  • clear and strong
  • good resistance to high temperatures
  • good barrier to moisture, gases oils and chemicals
  • > cough syrup bottles and other liquid forms
43
Q

what type of elastomers can you get and what are some example of these?

A

natural; made from rubber trees
e.g. latex
synthetic; petrochemicals
e.g. neoprene, nitrile

44
Q

what are dis/advantages of metal?

A 
\+ impermeable to; light, moisture, gases 
\+ heat resistant 
\+opaque 
\+ imprinted labels 
\+ light weight vs glass 
\+ rigid and shock resistant 
- costs less than less 
- chemical reactivity 
- opacity
45
Q

when are paper and cardboard primarily used?

A

they are widely used as secondary packaging

46
Q

what is the dis/advantages?

A 
\+ low cost 
\+ easy to recycle, non-toxic 
\+ easy to cut and fold 
\+ rigid and strong 
- poor barrier properties
- moisture sensitive 
- required additives for sealing 
- poor transparency
47
Q

what are closures used for?

A
  • to provide an effective hermetic seal

- to provide an effective microbiological seal and provide a suitable seal for the product

48
Q

what must be considered when looking at closures?

A
  • compatibility
  • barrier properties
  • easy to use
  • resistance to processing
  • appearance
  • additional functionalities
49
Q

what is the goal of anti-counterfeiting strategies?

A

to prevent and/or detect counterfeiting

  • should act as a deterrent to counterfeiters
    1. overt strategies
    2. covert strategies
    3. forensic markers
50
Q

what is the overt strategies?

A 
- out in the open 
\+ product verified by user
\+ can be decorative or a deterrent 
- must be educated 
- easy to mimic
- can increase cost and false assurance
- must not be re-usable or recyclable 
e.g. holograms 
- colour shifting inks/films
51
Q

what is the covert strategies?

A 
- hidden
\+ simple and low cost 
\+ easy to add and modify 
\+ no approval needed
- easy to copy 
- risk of being compromised 
- higher cost for more secure measures 
e.g. invisible ink, embedded images, odour, laser coding
52
Q

what is the forensic markers?

A 
- target; brand ownder
\+ highly secure
- allows authentication 
- not detectable under normal conditions 
- cost
- availability may be limited 
- requires access to specific equipment 
- increased risk of compromise with wider use
e.g. taggants, isotope ratio
53
Q

what are benefits of glass vial closures?

A
  • extra level of protection given by a dust cap but is not in direct contact with product
  • has dust cap, aluminium ring, rubber plug
54
Q

what are the types of closures you can get?

A
  1. screw caps
    - seal produced by liner inside cap that presses against container opening; made of plastic and metal
  2. Lug caps
    - similar to screw cap only need 1/4 of turn; normal and vacuum pressure closing
  3. crown caps
    - crimped closure; used for beverages
  4. child resistant caps
    - not left infront of children
  5. roll on
    - hermetic seal; can be easily removed or easily re-sealed
    - roll-on pilfer proof closures; similar to roll on and tamper evident
  6. tamper-evident closures
    - made of white PP or LDPE
    - band must be removed fro opening

SOM 2 (10 decks)

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