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S2 Case 3 - asthma & COPD > Inhalation Product Design > Flashcards

Inhalation Product Design Flashcards

1
Q

What must be considered in inhaler design?

A

Right dose delivered
Aerodynamic particle
Patient + clinician acceptability
Cost
Ease of use

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2
Q

What is the most suitable particle size?

A

2-5 micrometer

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3
Q

What are the scientific challenges?

A

Poor site targeting
Poor intracellular delivery
Toxicology
Poor in vitro-in vivo correlation
Formulation instability

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4
Q

What does in vitro study determine?

A

Performance in a controlled environment outside of a living organism

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5
Q

Describe the process for designing a new inhalable

A

Fully characterised drug formulation
Device selection
Dose retrieval
Characterisation post aerosolisation
Bioactivity pre/post aerosolisation
Breathing simulator studies
In vitro bioactive inhaled therapeutic
In vivo studies

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6
Q

What are the BP tests for inhaler devices?

A

Uniformity of delivered dose
Fine particle dose
Aerodynamic particle size distribution
Number of deliveries per inhaler
Effectiveness of antimicrobial preservative
Leakage (pMDIs)

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7
Q

What does the uniformity of delivered dose ensure?

A

Consistency of the dose emitted + fine particle mass throughout the life of container form

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8
Q

What do DPIs rely on?

A

Patient’s inspiratory flow rate than propellant for dose emission

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9
Q

What is fine particle dose?

A

Amount of delivered dose that lies below 5 micrometre cut-off

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10
Q

How is fine particle dose determined?

A

In parallel to aerodynamic particle size distribution

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11
Q

What does aerodynamic particle size distribution determine?

A

Where the API is deposited

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12
Q

What is the fraction that is deposited in the lung referred as?

A

Fine particle fraction (FPF)

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13
Q

What is the optimal size for peripheral airway deposition?

A

Upper limit = 5 micrometre
Lower limit = 1 micrometre

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14
Q

How do cascade impactors work?

A

Comprise a series of progressively finer jets + collection plates
Separate particles on basis of particle inertia

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15
Q

Describe cascade impactor operation

A

Samples drawn into impactor flowing
Nozzle size + area decrease with stage number
Particles remain or break through lines of flow
Particles with sufficient inertia collected rest pass on to next stage

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16
Q

What are the different cascade impactor designs?

A

Glass impinger
Multi-stage liquid impinger (MSLI)
Andersen cascade impactor (ACI)
Next generation impactor (NGI)

17
Q

What are glass impingers used to test?

A

pMDIs
DPIs
Nebulisers

18
Q

What is problem with glass impingers?

A

Limited info regarding particle size
= 2 stages

19
Q

Particles collected in throat of glass impinger considered?

A

“Non-respirable” = NOT inhaled into lower respiratory tract

20
Q

Particles collected in lower impinger considered?

A

“Respirable”

21
Q

What does MSLI test?

A

DPIs
pMDIs

22
Q

Describe MSLI

A

4 stages with filter terminal

23
Q

How are the collection stages kept in MSLI?

A

Moist
= eliminates particle bouncing off the collection plate

24
Q

Describe ACI

A

8-stage cascade impactor

25
Q

What does the ACI test?

A

MDIs
DPIs

26
Q

What are the advantages of ACI?

A

Easy to handle stack-up design
Damaged stages can be replaced

27
Q

Describe NGI

A

Cups rather than plates
7-stages

28
Q

What rate does NGI operate between?

A

15-100 L/min flow rates

29
Q

What does the NGI test?

A

pMDIs
DPIs
Nebulisers

30
Q

Describe the number of deliveries per inhaler BP test

A

Take an inhaler + discharge the contents to waste until empty

31
Q

What are the requirements of number of deliveries per inhaler BP test?

A

Total number of deliveries discharged from inhaler must not be less than number stated on product label

32
Q

Describe the efficacy of antimicrobial preservative BP test

A

Preservative properties adequate
= significant fall or no increase in number of micro-organisms

33
Q

What is the formulation for leakage pMDIs BP test?

A

Solution/suspension

34
Q

What is the requirement for the leakage pMDIs BP test?

A

Not more than 10% of the nominal fill mass of the container over entire shelf life

35
Q

What is used in uniformity of delivered dose test + why?

A

Critical flow controller to allow adjustable flow + inhaled vol

36
Q

Why is breathing pattern important?

A

Determines amount of API available for the patients

37
Q

What is the uniformity of delivered dose test based on?

A

Standardised tidal flow conditions generated by breath simulator

S2 Case 3 - asthma & COPD (25 decks)

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