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In vitro, ex vivo, in vivo veritas

In vitro assessments of inhaler performance are important in product development and quality control, but are not, as such, good predictors of performance in vivo. It is, however, possible to modify in vitro techniques so that they more closely resemble the in vivo situation. Measurements of fine‐particle dose (defined as the amount of drug with an aerodynamic diameter less than 5 μm) by cascade impactor have shown that the measured fine‐particle dose in vitro is highly dependent on the geometry of the inlet to the impactor, the fine‐particle dose being considerably lower when the cast of a human throat (an “anatomical throat”) is used than when a standard glass inlet is used. This difference is, however, less with a dry‐powder inhaler such as Turbuhaler® than with a pressurized metered‐dose inhaler (pMDI). Furthermore, there is a good correlation between fine‐particle dose measured in vitro and in vivo lung deposition, provided that an anatomically correct inlet is used for the in vitro determination. Studies in children have shown that the degree of lung deposition of budesonide, delivered via Turbuhaler, is of the same order of size as the in vitro fine‐particle dose. No comparable data are available for pMDIs; however, since children are smaller than adults, it is likely that differences in lung deposition between Turbuhaler and pMDIs are probably greater in children than in adults.