Improving IVIVCs

Making a relatively small investment in systems that enhance the clinical realism of standard pharmacopoeial in-vitro test set-ups for the delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement may help bridge the gap between data collected during QC testing and in vivo performance helping to accelerate and improve R&D.

Improving IVIVCs

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Inhaled Dissolution
Inhaled Dissolution
In the case of inhaled and nasal drug delivery products, once the drug is deposited to the target site, the absorption or lung uptake, and hence the therapeutic effectiveness of the drug, depends on the active dissolving in the small amounts of aqueous fluid and lung surfactant available.
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Facemask Testing
Facemask Testing

Many spacers/VHCs and nebulisers are used with facemasks instead of mouthpieces to administer the inhaled aerosol. This practice is commonplace in the case of infants and small children and in situations where the user lacks the capability of using a mouthpiece.

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Morphology
Morphology

Whilst cascade impaction provides a useful indication of where inhaled drug particles are likely to deposit within the respiratory tract, it does not profile the morphological properties of these particles.

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Cold Freon® Effect
Cold Freon® Effect

Cold Freon®” effect is the inadvertent reaction to the chilling sensation that hits the back of the throat following actuation of usually MDIs or Nasal devices.

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IVIVC Test Systems for DDU and APSD
IVIVC Test Systems for DDU and APSD

Two factors have been identified as being critical to improving the clinical relevance of DDU testing and APSD measurement: realistic breathing profiles and realistic throat and nasal models.

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