Abstract
Background: Nasal casts may characterize intranasal drug deposition. Methodology: The Koken cast, described as 'anatomically correct', and the Optinose cast, derived from MRI of a healthy male during velum closure, were dimensionally compared and assessed for deposition assessment suitability. Results: Smallest vertical cross-sectional areas (valve region) for Koken and Optinose right/left: 2.55/2.75and 1.18/1.18cm2, respectively, versus a 'normative' mean (range) of 0.85cm2 (0.2-1.6cm2). Intranasal volumes differed (computed tomography/water fill): Koken, 35.8/38.6cm3 and Optinose, 24.1/25.0cm3, versus a 'normative' mean (range) of 26.4cm3 (20.9-31.1cm3). Conclusion: Koken cast dimensions are larger than the normal range and the Optinose cast. The validity of casts for regulatory drug deposition studies is suspect.
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