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Lab 2 > packaging... > Flashcards

packaging... Flashcards

1
Q

whats Primary packaging?

A

Directly in contact with product

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2
Q

Primary packaging requirements?

A
  • compatible with content and protection form hazards
  • Consider incompatibility: nothing leaving product/ entering and affecting packaging/product
  • Provide info on content: bar code, expiry date, batch num etc
  • Ideally be child-resistant but easy to open and re-seal by patient
  • Be tamper-resistant/ offer proof of tampering
  • Be fit for purpose i.e. blister packs for tablets but not for semi-solids
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3
Q

how many types of packaging? (stages)

A

primary
secondary
tertiary

3

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4
Q

Secondary packaging Containment. role?

A
  • Added layer of protection from light etc.
  • Get more info on product- dose, use, image- important for patient to ensure correct content. May be bottle/box
  • Dispensing label also provided.

e.g. pill boxes

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5
Q

requirements for packaging in general?

A

should
• NOT leak
• NOT allow diffusion/permeation of product vice versa
• BE strong enough during all steps of handling, storage, transport, use
• NOT be altered by the formulation it contains.= may not be fit fr purpose during shelf life

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6
Q

what do you want to maintain w pharm product?

A

quality, safety, stability of pharmaceutical product throughout shelf lfie

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7
Q

4 types of hazards?

A

mechanical: shock/impact
chemical: adsorption/ loss of volatiles/ leaching
biological: contamination
climatic: tesmp, moisture, pressure

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8
Q

Identification, Presentation and information

A
  • Additional roles of packaging
  • essential source of information on medicinal products.
  • Info leaflet still part of packaging
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9
Q

what information is added on packaging?

A
  • Product name
  • Type of product
  • Quantity / strength / BN
  • Mode of administration
  • Date of manufacture
  • Shelf-life / expiry / date
  • Storage instructions
  • Contraindications / precautions
  • MA / ML numbers
  • Legal classification
  • Manufacturer’s name / address
  • Bar code
  • Warnings (i.e. KOOROC)
  • Formulation details (i.e. Ingredients)

i.e. on pill box

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10
Q

Risks due to similar looking packaging

A

could be same drug, different doses/ different salts of same drug/ different drug but similar packaging.
Very confusing for patient and carer to distinguish

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11
Q

types of Containers for primary packaging

Can be multiple at same time, need to be most appropriate for product and use

A 
single / multi dose
airtight
sealed
tamper evident
well closed
child resistant
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12
Q

characteristics of tablet bottles

A

o Made of glass or plastic
o Amber-coloured
o Child-resistant cap

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13
Q

types of medicine bottles?

A

o Amber-coloured bottle
o Fluted amber bottle
 Child resistant cap
o Dropper bottle

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14
Q

Single dose containers e.g:

A
  • Glass ampoules
  • Infusion bags
  • Single-dose syringes
  • Nebuliser ampoules
  • Don’t need preservatives
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15
Q

Multi dose containers

A
  • Multi-dose vials for injectables
  • Multi-dose glass/plastic bottle.
  • Pressurised metered dose inhalers
  • Dry powder inhalers
  • Cream jar/bottle/tube (semi-solids)
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16
Q

role of Light Resistant Containers?

A
  • Protect the contents from the effects of UV radiation at a wavelength between 290 nm and 450 nm.
  • For example amber bottles
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17
Q

what are Sealed containers and give examples

A

i.e. closure and container form same unit
sealed during packaging and cant be resealed once used
Prevents product from contaminants such as air or moisture. e.g.
• Ampoules
• Aluminium bags
• Plastic eye-drops

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18
Q

Laminates from foil and films

Used for …

A 
suppositories, sachets,
Blister packs:
•	Tray with lid used as packaging for tablets and capsules
•	Provides hermetic seal
•	Good barrier properties
•	Metal (excellent barrier)
•	Plastic (coated PVC)
•	Tamper-evident- packaging damaged with tablet removal
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19
Q

Unit dose packaging- strips use?

A
  • In the Strip packaging, the tables or capsules are sealed between two same materials, such as aluminium foil, heat sealed.
  • This packaging protects the tablets/capsules from environment
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20
Q

Tubes and jars types?

A

Collapsible tubes for semi-solids

Ointment jars

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21
Q

2 forms of Collapsible tubes for semi-solids

A

Lacquered aluminium
Sealed at both end
Pierce to use

LDPE/HDPE/PP
Can be heat sealed
Made of plastic with layer of foil that must be removed

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22
Q

Ointment jars

A

 Wide-mouthed
 Semi-solid preparations
 Risk of contamination by patient

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23
Q

Repackaging- what req must be met

benefits?

A

• Patient can access all the information about the product
• Less time-consuming: so more time for counselling
• Lower risk of errors or cross-contamination
From bulk bottle:
number of capsules/tablets counted and transferred to bottle.

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24
Q

Compliance aid problems

A

higher risk of error
• Less info to patient
• May be cross-contaminations/ incompatibilities with meds. Stability affected compared to original packaging.
• If meds stopped- right product removed from this. Legal issues to- removal into compliance aids
Other options to aid compliance and help patient remember dose.
Date/ scratch label on blister pack: good for 1 med a day

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25
Q

packaging material what to consider?

A 
dosage form
shelf life
dispensed/ OTC?
cost
MoAdmin
product
patient
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26
Q

types of Glass

A 
Traditional material, made of:
•	Silica 
•	Limestone (calcium carbonate)
•	Soda ash (sodium carbonate)
•	Cullet. Broken glass
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27
Q

why may additives be added to glass?

A

o Hardness
o Heat-shock resistance
o Opacity/clarity
o Colour
 Amber-coloured glass: protection against sun rays
• Iron, carbon or manganese oxides & sulphur containing compounds

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28
Q

Advantages of glass

A
  • Inert (relatively)
  • Impervious to air
  • Impervious to moisture
  • Protects from loss of volatiles. GTN
  • Easy inspection of the content
  • Can be tinted to block harmful light rays
  • Easy to clean
  • Easy to sterilise by heat
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29
Q

disadvantages of glass

A

• Brittleness
Release of glass fragments- filter before injected into body
Contamination through cracks
• Release of alkaline compounds- degradation lectures
• Cost- used scarcely for extra protection
• Weight
• Leaching of glass components
e.g. weatherisation (bloom

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30
Q 
whats Weatherisation (bloom) destabilisation of glass?
and what can be done?
A

Appearance of white, opaque stains on glass
o Storage at high temperatures/humidity
o Storage under conditions where temperature/humidity fluctuate

= Migration of carbonate crystals on the glass surface
May be more problematic for Type II glass (soda-lime)

What can be done?
o Leaching can be reduced by soaking in hot water or dilute acid solution

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31
Q

hm types of glass and which is highest quality?

A

Type I: highest quality
Type II
Type III

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32
Q

Type I glass examples

A 
Borosilicate glass
Most inert type of glass
  Lowest risk of leaching
Low coefficient of thermal expansion
  Resistance to sudden temperature changes.- heat sterilisation, less likely to crack
££££

E.g.
• Ampoules
• Injection vials
Suitable for packaging slightly acidic solutions

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33
Q

Type II glass examples

A

Soda-lime glass
• Treated soda-lime glass (sulphur dioxides)
• Lower risk of leaching vs. Type III
• Type III
Use: Aqueous solutions (slightly acidic/neutral)

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34
Q

Type III glass examples and use

A

Soda-lime glass (also type II)
• Similar to food packaging (NP glass)

Use:
• Non-aqueous parenteral products
• Powders for injection (not freeze-dried)
NP glass
Large volume non-parenteral products (> 100 mL)

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35
Q

Plastic use?

A

Many uses primary and secondary e.g. infusion bags in a plastic bag:
• packaging of tablets, capsules: rigid bottles
• for eye drops, nasal sprays: squeezable
• as jars or flexible tubes
• in blister or strips packs
• as infusion bags and for the packaging of SVPs
• as closures for bottles

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36
Q

2 types of plastics?

A

thermoplastics

  • can be remoulded + heated multiple times, keep same properties
  • e.g. PE, PS, PPE, PET, PVC, nylon, acrylic

thermosettling plastics

  • Can only be heated and moulded once
  • As cross-linked polymer chains
  • e.g. epoxides, polyester resin, urea formaldehyde
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37
Q

4 Typical plastic containers:?

A
  • Polymer
  • Polymerisation residues
  • Additives added to modify the properties of the plastic- consider conpatibility
  • Processing aids
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38
Q

additives to plastic?

A 
plasticisers
lubricants
stablisers
UV absorbers
antioxidants
toughening agents
flame retardants
colouring agents
filling/ reinforcing agents
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39
Q

plastics and additives: Advantages

A
  • Low cost
  • Low particle release
  • Light in weight
  • Heat sealable
  • Easily moulded (above)
  • Multipurpose
  • Can be clear/opaque
  • Resistant to shocks (mostly)
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40
Q

plastics and additives: disadvantages

A

Not as inert as Type I glass
Stability issues
• Stress-cracking. Wetting agents, oils, organic solvents (LDPE)
• Distortion e.g. dimpling during autoclaving
• Sensitivity to heat- Problematic for sterilisation. All will soften under heat
• Electrostatic charge
• Leaching of additives *

Adsorption
• Loss of preservative- affect stability

Poor barrier properties
• to sun rays (unless black)
• to gas/vapour

(squahed milk carton)

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41
Q

7 different plastics?

A 
PE
PP
PVC
PVDC
PCTFE
PS
PET
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42
Q

describe plastic 1: Poly(ethylene) [PE]

A

Good compatibility with drugs overall but can sorb preservatives

Low-density polyethylene (LDPE)
- Clear & flexible e.g. squeeze bottles, blister packs

High-density polyethylene (HDPE)

  • Strong, rigid & translucent
  • Compared to LDPE: Lower permeability to gases and moisture; better resistance to oils; heat-resistant
  • Can be pigmented e.g. solid dosage form bottles
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43
Q

which plastic has poor odour barrier and permeable to oxygen?

A

Polyethylene PE

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44
Q

describe plastic 2: Poly(propylene) [PP]

A
  • Clear, strong & rigid
  • Heat-resistant, excellent barrier to moisture!

Compared to PE:
• Less additives and lower risk of adsorption
• better barrier to odours and better resistance to grease/oil

• Good resistance to cracking when bent
e.g. hinged closures, solid dosage form containers, blister packs (films)

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45
Q

describe plastic 3: Poly(vinyl chloride) [PVC]

A

• Variable rigidity, clear & glossy
• Plasticisers added to improve flexibility (i.v. bags)
• Heat-sensitive
• Poor impact resistance
• Can be improved by additives to the detriment of permeability
• Resistant to oils, fats, flavouring
• e.g. component of intravenous bags
not used as much as hard to get rid of PVC waste

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46
Q

describe plastic 4: Poly(vinylidene chloride) [PVDC]

A
  • Provides best barrier to moisture, gases, flavours & odours
  • Mixed with other plastics to improve barrier properties
  • Heat-resistant, clear, flexible
  • ££££ Expensive
  • Excellent barrier properties- remains integrity of drugs. Good if longer shelf life
  • e.g. blister packs
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47
Q

what plasticmakes blister packs?

A 
Poly(vinylidene chloride) [PVDC]
or Poly(chlorotrifluoroethylene) [PCTFE]
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48
Q

describe plastic 5: Poly(chlorotrifluoroethylene) [PCTFE]

A
  • Clear plastic
  • Heat-resistant
  • ££££
  • Excellent barrier properties. e.g. blister packs
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49
Q

describe plastic 6: Poly(styrene) [PS]

A
  • Crystal PS: clear, strong, rigid but brittle
  • PS foam: cushion, insulation, in urinalysis packaging
  • Poor impact resistance
  • Can be improved by additives to the detriment of permeability
  • Poor barrier to moisture, gases; poor chemical resistance
  • Insufficient heat resistance to resist autoclaving
  • Good for general purpose use
  • e.g. Bottles for tablets/capsules
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50
Q

describe plastic 7: Poly(ethylene terephthalate) [PET; polyester]

A
  • Clear and strong
  • Good resistance to high temperatures
  • Sterilisation process possible
  • Good barrier to moisture, gases, oils, chemicals
  • Popular for cough syrup bottles and other liquid dosage forms
  • Replacement for PVC bottles
  • Sterilisation pouches (PET films)
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51
Q

Closures and counterfeiting measures

A

Rubbers and elastomers

Metals

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52
Q

what are elastomers?

A

elastic polymers
Rubbers are formulations of elastomers + additives
Some formulations may contain more additives than plastics!

Increased risks of incompatibility? consider
• Mostly used in closures (e.g. parenteral vial stoppers)
o Soft and easy to mould
Adopt the shape of the container to provide a tight sea

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53
Q

What additives may be in plastic?

A

Colouring agents
Antioxidants
Lubricants
Anti-slip

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54
Q

Advantages of plastic?

A

lightweight, easy to mold, cheap, can’t be corroded, durable and strong

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55
Q

Disadvantages of plastic for packaging

A

Stress-cracking
Distortion
Sensitivity to heat

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56
Q

Disadvantage of poly(ethene) PE

A

can sorb preservatives

57
Q

Why is poly(propylene) PP better than poly(ethene)

A

Lower risk of adsorption
Less additives
Good barrier to moisture

58
Q

Disadvantages of PVC

A

poor impact resistance

59
Q

Characteristics of PVDC

A

Best barrier to moisture, gases, flavours and odours.
Heat resistant, clear, flexible.
Excellent barrier properties
EXPENSIVE

60
Q

What is the primary use of elastomers in packaging?

A

Closures

61
Q

2 types of elastomers?

A

natural- form rubber trees

synthetic- form petrochemicals

62
Q

elastomers: examples of the 2 types?

A

natural: latex
sytnhetic: neoprene, nitrile, butyl, chlorobutyl, bromobutyl, silicone (most inert, poor barrier)

63
Q

how are natural elastoemrs betetr than synthetic?

A

better resealing

better resitante to coring/fragmentation

64
Q

how are SYNTHETIC elastoemrs betetr than natural?

A

better:
barrier to moisture, gases
resistance to aging
resistant to multiple autoclaving

lower risk of preservative adsorption

65
Q

Metals use?

A

Containers
o Collapsible tubes
o pMDI canisters
o Pouches, blister and strip packs

Closures. Pierce/remove to access containers. Tamper proof
o Rolled-on closures
o Rolled-on pilfer proof closures
o Foil caps

66
Q

what metals used?

A

Mostly aluminium, tin, stainless steel

67
Q

metaks Advantages

A
  • Impermeable to Light, moisture, gases
  • Rigid and shock resistant. pMDIs
  • Light weight vs. glass
  • Heat resistant
  • Opaque- protect from UV rays
  • Imprinted labels- info in blister packs on foil backing
68
Q

metals Disadvantages

A
  • Cost (less than glass)
  • Chemical reactivity. Coated metal (epoxy resins)
  • Opacity- cant see inside packaging to check
69
Q

Paper and cardboard when used?

A
  • Rarely used for primary packaging- extemporaneous preparation of sachets
  • Secondary packaging: more common e.g. cover labels, cartons, dispensing bags, PILs etc
70
Q

paper and card: ads?

A
  • Low cost, can be tailored for application
  • Easy to recycle, non-toxic
  • Easy to cut and fold
  • Rigid and strong. Cardboard
71
Q

paper and card: disads?

A
  • Poor barrier properties
  • Moisture-sensitive
  • Required additives to be sealed i.e. glue, not just pressed closed like metal
  • Poor transparency
72
Q

Closures

Function:

A 
•	Provide effective hermetic seal:
o	Protect product from external contaminants
o	Retains contents inside container
•	Effective microbiological seal
•	Provide seal suitable for product
73
Q

Closures

Considerations

A
  • Compatibility: with product and environment: air/space
  • Barrier properties
  • Ease of use: open and reseal
  • Resistance to processing: maintains integrity when processed at high speed too
  • Appearance: fits with container for visual appealing product, decrease risk of leaks
74
Q

Additional functionalities of closures

A

o May help with drug administration- liquids: cap has info for dose
o May provide child-resistance and evidence of tampering

75
Q

Glass vial closures (3)

A

Dust cap
Aluminimum ring
Rubber plug

76
Q

Rubber plug- what is it and describe?

A

Glass vial closures

in direct contact with produc. Reisitant to punctures

77
Q

Aluminium ring - what is it and describe?

A

Glass vial closures

seals rubber plus onto vial. Can be lifted: been tampered. Gets punctured with needle

78
Q

Dust cap - what is it and describe?

A

Glass vial closures

not direct contact but extra protection

79
Q

7 Type of closures

A 
Screw caps
Lug caps:
Crown caps
Roll on
Roll-on pilfer proof closures
Child-resistant caps
Tamper-evident closures- Jaycap® closure
80
Q

Type of closures: Screw caps

A

• Seal produced by the liner inside the cap which presses against the container’s opening
• Typically made of plastic and metal
o Thermoplastic/ thermosetting
o Tin plated or aluminium metal

81
Q

Type of closures: lug caps

A

• Similar to threaded screw cap
o only requires a quarter of turn
• Normal and vacuum pressure closing
• Jams jars. Less common with meds

82
Q

Type of closures:roll on

A

• Hermetic seal
o Easily removed
o Easily re-sealed

82
Q

Type of closures:roll on

A

• Hermetic seal
o Easily removed
o Easily re-sealed

83
Q

Type of closures: crown caps

A

• Crimped closure

o Used for beverages (often in glass bottles)

84
Q

Type of closures: Roll-on pilfer proof closures

A

• Similar to roll-on
o Tamper-evident: add on level compared to just roll-on:
o Band broken when first opened

85
Q

What are the three types of anti-counterfeiting strategies

A

o Overt measures
o Covert measures
o Forensic markers

-Serialisation & Track and trace (e.g. bar code, microchip (radiofrequency)

86
Q

Overt strategies

what and target?

A
  • Out in the open

* Target: end user to determine if correct product.

87
Q

overt strategies ads and disads?

A

Advantages
• Product verified by user
• Can be decorative
• Can be a deterrent

Disadvantages
•	Used must be educated
•	May be easy to mimic
•	Can increase production cost
•	False assurance
•	Must not be re-usable or recyclable
•	Should damage the pack once opened
88
Q

Covert strategies ads and disads?

A 
Advantages 
•	Can be simple and low cost
•	Easy to add and modify
•	No approval required
•	Can be in-house or supplied	
Disadvantages
•	Can be easy to copy
•	Risk of being compromised
•	Secure supply chain
•	Higher cost for more secure measures
89
Q

examples of overt strategies?

A
  • Holograms
  • Colour shifting inks/films
  • Security graphics
  • Sequential product numbering
  • On product marking
90
Q

examples of Covert strategies?

A
  • Invisible ink
  • Embedded images
  • Digital watermarks
  • Odour
  • Laser coding
  • Watermarks in PIL
  • Substrates
91
Q

what are covert strategies and whos target?

A
  • Hidden (‘need to know basis’)

* Target: brand owner

92
Q

forensic markers- whos target?

A

brand owner

93
Q

forensic markers ads and disads?

A

Advantages
• Highly secure
• Allows authentication
• Not detectable under normal conditions

Disadvantages
•	Cost
•	Proprietary technologies
•	Increased risk of compromise with wider use
•	Requires access to specific equipment
•	Availability may be limited
94
Q

forensic markers examples?

A 
Taggants
o	Chemical
o	Biological
o	DNA
o	Microscopic
Isotope ratio
95
Q

What is Class 1 to Class 4 in product recall.

A

Class 1 - Death
Class 2 - Affect Patient Safety
Class 3 - No harm would be caused
Class 4 - Cannot be used effectively

96
Q

What makes a quality product (at each time process carried out)
for tabs?

A
  • Content of drug
  • Disintegration
  • Dissolution
  • Stability and shelf life- term 2
97
Q

Poor quality products

Complaints by:

A
  • Wholesalers
  • Distributors
  • Pharmacies
  • Consumers: appearance- colour, solution precipitated, packaging/product not coming out i.e. nasal spray nozzle
98
Q

Impact of not meeting quality standards 4

A
  • Lack of therapeutic efficacy
  • Toxic and adverse reactions
  • Waste of limited financial resources- cost increased
  • Loss of credibility of the health care delivery system- assumed inadequate checks in place to maintain quality
99
Q

What is a certificate of analysis?

A

Proof of quality of product

Details of tests carried out to show starting raw materials are good quality and sourced well.

100
Q

Quality of pharmaceutical products
• Pharmaceutical quality is affected by
…

A 
o	Starting materials
o	Manufacturing processes
o	Packaging
o	Transportation
o	Storage conditions
101
Q

• Quality of pharmaceutical products is measured by

A

o Physical analysis

o Chemical analysis

102
Q

Starting ingredients for quality of pahrm product?

A

CofAs = certificates of analysis
• Demonstrates quality of product
• Evidence that starting material is good

103
Q

What are polymorphic forms of a drug?

A

Different. crystalline forms whihc differ in their physical properties.

104
Q

Substance for Pharmaceutical use under same heading in BP (4)

A

Description/Characters
o a qualitative statement about the state (e.g. solid, liquid) and colour of the new drug substance.

Identification
o identification tests should be specific for the drug substance

Assay
o A specific, stability-indicating procedure should be included to determine the content of the new drug substance.

Impurities
o a method to detect and quantify impurities is required

105
Q

What are Class 1 to Class 3 solvents?

A

Class 1 - To be avoided
Class 2 - To be limited
Class 3 - Low toxic potential

106
Q

examples of Class 1 to Class 3 solvents?

A

1: Known human carcinogens, strongly suspected human carcinogens, and environmental hazards.

2: Non-genotoxic animal carcinogens or possible causative agents of other irreversible toxicity such as neurotoxicity or teratogenicity.
Solvents suspected of other significant but reversible toxicities.

3: Solvents with low toxic potential to man; no health-based exposure limit is needed. Class 3 solvents have (permitted daily exposure) PDEs of 50 mg or more per day.

107
Q

particle size assessment acceptance criterial?

A

include acceptable particle size distribution
o in terms of the percent of total particles in given size ranges.
• Acceptance criteria should be set based on the observed range of variation, and should take into account
o the dissolution profiles of the batches as well as the intended use of the product

coarse
mod fine
fine
very fine

108
Q

Microbiological quality 4

A 
•	Bioburden
•	Sterility
•	Bacterial endotoxins
•	Pyrogens
Last two different in term of meeting the specifications
109
Q

What are specials?

A

unlicensed medicinal products manufactured for human use to meet a specific prescription requirement ordered for individual patients without the need for the manufacturer to hold a marketing authorisation for the medicinal product

110
Q

why/when specials supplied?

A

Special can be supplied: To meet individual patient needs when no equivalent licensed product exists. E.g. allergies, difficulty to swallow

111
Q

2 types of specials?

A

• Batch manufactured products
• Bespoke products: made for specific patient, tests possible on these are limited
Required a Manufacturer’s Specials licence
• To ensure that products meet regulatory standards

112
Q

Specials and quality issues

2 certificates:

A

Certificate of analysis:
o batch manufactured special.
o Proof of physical, chemical, or microbiological assay of sample of final product. Tests done
o Special medicine manufactured as bespoke will not have end product analytical testing

Certificate of conformity
o bespoke products meets purchaser’s specifications
o Limited info provided.
o Get this certificate for either type of special.
o Available for all specials produced by a license holder

113
Q

Pharmacists responsibility and specials what to check?

A

• product is of a suitable standard.
• product comes with a certificate of analysis or a certificate of conformity. Good if have info on raw materials
• product is appropriate and suitable for the patient
• certificate and/or label mentions
o Strength
o Formulation details
o Excipients list
• is evidence to support the labelled shelf life of the product

114
Q

What is a specification?

A

A list of tests, references to analytical procedures and appropriate acceptance criteria, which are numerical limits, ranges or other criteria for the tests

115
Q

How specifications are set:

A
  • help confirm quality of a drug substance/product
  • not meant to provide a detailed description of all characteristics
  • should focus on ensuring drug substance/product is safe and effective
  • need to collect relevant data: some degree of variability naturally linked with analytical methods/ manufacturing processes
116
Q

physicochemical tests for…

  • tabs
  • caps
  • injections
  • buccal films
  • transdermal patches
  • oitments/creams
  • aerosols
  • bitter dosage forms
A
  • dissolution, mech strength
  • drug release
  • precipitation
  • strength
  • adhesivity
  • rheology
  • P size, aerodynamic diameter
  • taste sensation
117
Q

• Development of pharmaceutical products should include

A

• Definition of the quality target product profile (QTPP)
• Identification of critical quality attributes (CQAs)
o For the drug product- final pharmaceutical prep
o For the drug substance/excipients- raw starting materials
• Selection of suitable manufacturing processes
• Control strategy- give assurance that process is fit for purpose and gives quality product

118
Q

What is a QTTP?

A

Quality Target Product Profile

A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into consideration safety and efficacy of the drug product

119
Q

What is a CQA?

A

A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range or distribution to ensure the desired product quality.

120
Q

What is a critical process parameter?

A

A process parameter whose variability has an impact on critical quality attribute (CQA) and therfore should be monitored or controlled to ensure the process priduces the desired quality.

121
Q

What is the requirement for bioequivalence for generic medicines?

A

The drug should not be better or worse than the reference product, but allows products to be used interchangeably.

122
Q

whta type of approach is: quality by testsing (QbT) and quality by design? (QbD)

A
  • empirical

- systematci

123
Q

QTTP what to consider?

A
  • Intended use, route, dosage form
  • Dose strength
  • Closures and other packaging
  • Drug release/delivery, parameters affecting pharmacokinetics
  • Product quality criteria: sterility, purity, stability
124
Q

CQAs can be defined for

A
  • Drug substances
  • Drug products
  • Excipients
  • Intermediates (in-process testing)
125
Q

what 4 things are a quality attribute of drug (CQA)? - and targets of each?

!!!

A

Identification
- positive for labelled drug

Assay
- 100% of labelled claim

Content uniformity
- conforms to BP criteria?

dissolution
- >80% released at 30 mins

everything else = QTPP

126
Q

Critical process parameter

For tablets, CPPs could include any step in manufacturing:

A
  • Mixing
  • Granulation
  • Drying
  • Compression
  • Coating
127
Q

CPP

Solid dosage forms

A 
•	Identification
•	Assay
•	Uniformity of content
•	Dissolution, can be affected by:
	Hardness
	Friability 
	Disintegration
128
Q

What controls dissolution

A

pyramid image…

Can define limits for hardness etc if known to impact

Have limits for each section, predict which batch will perform well etc

129
Q

dissolution specification

example for a simple immediate release tablet:
Analytical measurement to see how much drug released must be
…

A
  • Linear (calibration curve)
  • Must be accurate (> 98%)
  • Must be repeatable (< 5% RSD)
  • Must be reproducible
130
Q

Bioequivalence (specifications)

Aim

A

To determine if two pharmaceutical products demonstrate in vivo biological equivalence- both have same therapeutic effect.

131
Q

Generic medicines must prove bioequivalence to an existing medicine… (2)

A

Patient compliance: The expected result
Effective therapy
o Neither toxic nor ineffective as same
o Medicines may be interchanged= good for patient and NHS. Efficient

132
Q

To establish bioequivalence, we will often rely on …

A

PK parameters

133
Q

why Plasma concentration vs time curves used for bioequivalence establishing?

A

as blood circulation commonly site of action

134
Q

Need to know X and X, carefully consider how often and when to take samples

A

absorption and elimination

135
Q

what do we need adequate estimates of for bioequiv?

A

Cmax
o ideally few points before and after
o shouldn’t be first conc in conc vs time profile!

tmax
o Need enough info for this
o Don’t want it to be at first/end itime point again- want some before and after

  • Sufficient duration of sampling to provide a good estimate of exposure (80% of the AUC extrapolated to infinity). Need full picture, from enough time points
  • At least 3-4 samples to have a good estimate of the terminal half-life
  • Single/multiple doses? If multiple doses give additional sampling points will be required
136
Q

Acceptable range: in graph for bioequiv?

A

AUC ratio: Total exposure to drug
- within the 90% confidence interval: 0.80 – 1.25 of the reference value

Cmax ratio: Max conc acheived
- within the 90% confidence interval: 0.80 – 1.25 of the reference value

However this can be
- tighter for drugs with a narrow therapeutic index;
- wider in some cases where we expect high variability in PK to 0.75-1.33
for both: look at test and compare with BP

137
Q

bioequiv criteria for accpetance of durg?

A

within the 90% confidence interval: 0.80 – 1.25 of the reference value

Lab 2 (12 decks)

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