VariDose Inhalation measured instantly

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VariDoseInhalation measured instantly

• Paediatric respiratory drug delivery
• Da Vinci network meeting, 11th January 2007
• Olga Kusmartseva

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In memory of Professor Peter R Smith
Dearly missed. We will try to continue his
legacy and aspiration for VariDose technology to
the best of our abilities.
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Aims and backgrounds of the invention
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VariDose

• VariDose is patented technology that addresses
  the need for in-line, real time performance
  measurement of drug inhalers
• The VariDose device uses state of the art
  optoelectronics to provide four-dimensional
  measurement of particle clouds
• VariDose is applicable to all types of inhalers

Theory
Data
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Theory of light obscuration
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Cloud structure and evolution
Optical Density
time
time
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Cloud parameters
Pulmicort Turbohaler
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Product User Scenarios
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Diversity of experimental set-ups

• With a throat piece

• With CI

• Creating defects

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Varidose/Twin Stage Impinger Cross-validation

• Bricanyl Turbohaler
• Only drug formulation
• 500mg of Terbutaline Sulphate
• Micronised powder
• 20 single actuations

Biosensors and Bioelectronics 20(2004) 468-474
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Turbohaler Dose Variation

• Pulmicort 200mg Budesonide
• Small dose
• Micronised powder
• No other ingredients

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Varidose/NGI Cross-evaluation

• Dry Powder Inhaler
• Single-dose blisters
• Micronised salbutamol sulphate 40
• Respitose (sizes 45mm to 90mm) 60
• Formulation load
• 0.8mg and 1.0mg
• 30 actuations (3x53x5)
• High FPF (94 to 97)

Proceedings DDL 15 (2004) 183-186
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Varidose/Andersen CI Cross-validation

• ACI Assays
• Flow rate60L/min
• Two samples
• Coarse Particles
• Fine particles
• UV spectroscopy
• l239nm

• A carrier based DPI
• A Reservoir Inhaler
• Metered dose15mg
• Respitose
• size range 30mm to 100mm
• VMD61.83mm
• Micronised drug
• Dose 0.5mg 5mg
• Without excipient fines

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p-MDI Performance

• Ventolin Evohaler 100mg
• Universal standard throat piece
• Flow rate of 28L/min
• One canister

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Differences between two p-MDIs
Ventolin Evohaler
Easi-Breathe
Ring 1
Ring 2
Each inhaler Contains 100mg Salbutamol per
metered dose
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Performance Difference of two p-MDIs
Each inhaler Contains 100mg Salbutamol per
metered dose
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p-MDI paediatric user scenario

• Possible research
• Time delay between the puff and the start of
  inhalation
• Effect of multiple puffs
• Effect of the inspiratory flow rate

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Benefits of VariDose

• Provides more data faster than alternatives,
  speeds up
• inhaler development testing
• Measures the drug delivery profile (3D-image)
• Measurement done on the cloud of small
  particles emitted by an inhalation device
• High throughput of assays with instantaneous
  result availability
• Provides unique information on the aerosol
  evolution
• Capable of being correlated with recognised
  laboratory assays
• Can be put in line with patient during delivery

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VariDose Future Plans

• In collaboration with pharmaceutical research
  laboratories to develop robust applications for
  their needs
• Device innovations
• Drug formulations
• In-production control
• In collaboration with clinicians to research
  in-line with patient applications
• Matching an inhaler with a patient using the
  breath simulating machine
• Virtual clinical trials
• p-MDI with Spacers and paediatric users