Breath Profiles for Testing New DPI Devices in Development
Byron PR, Wei X, Delvadia RR, Longest P, Venitz J.
Respiratory Drug Delivery 2014. Volume 1, 2014: 295-302.
Abstract:
Recent studies to characterize drug aerosols that pass through realistic in vitro models of the mouth and throat (MT models) produce results that depend on the geometry of the aerosol conduit and simulations of patients’ inhalation profiles (IPs). Unfortunately, the development scientist is presently unable to select the most appropriate IPs when performing this type of in vitro testing with a newly designed inhaler unless a clinical study has been performed with the inhaler to define a range of IPs that are appropriate. This presentation describes a general method of selecting a range of IPs for use with any powder inhaler of known resistance, provided the general instructions for inhalation from the device during use are consistent with those that normally accompany prescriptions for passive powder inhalers.
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