Engineering and Preclinical Validation of an Impaction-Based PIPAC Nebuliser (Capnotip®) with a Spraying Angle Over 150° and Improved Aerosol Homogeneity
Authors
Y. Sautkin, MD, PhD; H. Schoenfelder, Mag.; M.A. Reymond, MD MBA
Affiliations
R&D laboratory, Capnopharm GmbH, Tübingen, Germany
Background
Heterogeneous tissue drug distribution is reported after PIPAC. We engineered a 3rd-generation PIPAC nebuliser, based on impaction single-nozzle technology, to improve the homogeneity of tissue drug distribution. The performance of the new nebuliser (Capnotip®) was compared in vitro with that of the reference device (Capnopen®), (Capnopharm GmbH, Tübingen, Germany).
Methods
During aerosolisation, the flow is directed onto an impaction plate with optimised geometry, from which the aerosol is reflected. The Median Aerodynamic Diameter (MAD) of the aerosol droplets generated from distilled water, glucose 5 %, and silicon oil (5 cSt) was measured by laser diffraction spectroscopy (SprayTec™, Malvern, Kassel, Germany). The spraying angle was measured at the tip of the nebuliser and photodocumented. Aerosolisation patterns were depicted on 2D and 3D targets and compared between devices.
Results
The MAD was for distilled water, glucose 5 %, and silicon oil 5 cSt with Capnotip® vs Capnopen®:
| Distilled water (CI-95 %) | Glucose 5 % | Silicon oil 5 cSt | |
| Capnotip® | 26.1 (24-28) | 26.6 (26-28) | 35.5 (31-41) |
| Capnopen® | 29.3 (26-32) | 31.7 (31-32) | 26.7 (24-29) |
The mean angle of aerosolisation with Capnotip® vs Capnopen® was 155° vs 57°. The aerosolisation patterns on the 2D and 3D targets were qualitatively superior with Capnotip® vs Capnopen®, with some residual inhomogeneity.
Conclusion
The Capnotip® is a 3rd-generation, single-nozzle PIPAC nebuliser with an angle of aerosolisation over 150°, allowing a superior surface spray coverage vs the Capnopen®. The MAD was comparable between devices (under 36 µm) with a narrow distribution range. Pharmacological measurements are ongoing on the ex vivo enhanced inverted urinary bladder model (eIBUB).