Nephele Mixing Inlet
The aerodynamic particle size distribution (APSD) of inhaled drug products may depend on the inhalation flow rate versus time profile used by a patient. The patented Nephele Mixing Inlets (all covered by US Patent 6,435,004 and licensed to RDD Online) allow use of cascade impactors to establish the APSD following inhaler actuation according to simulated inhalation flow profiles based on patients. The mixing inlet enables internationally harmonized and calibrated cascade impactors, such as the Andersen Cascade Impactor (ACI) and Next Generation Impactor (NGI) that are recognized by regulators worldwide, to be adapted to sample the output of an inhaler under realistic flow conditions. When aerosols from inhalation devices are sampled through inlet ports with realistic "throat geometries", the technique enables investigators to compare the APSD of aerosols that penetrate the throat (and thus enter the lung) under various flow conditions likely to be used by patients.
All Nephele Mixing Inlets gently merge, with virtually no turbulence (and minimal aerosol losses) a particle-free sheath air stream with a second central air stream containing an aerosol. A Nephele Mixing Inlet mounted between the aerosol entry port (e.g. the USP Induction Port) and the inlet to the cascade impactor allows the impactor to be operated at a constant flow rate (e.g. 60 LPM) while allowing a lower fixed or variable flow rate to draw aerosol from the inhaler device and entry port. A typical experimental set-up is shown below.
- The Nephele Mixing Inlet fits between the USP Induction Port (or other realistic throat geometry model) and the inlet of a cascade impactor
- Supplemental, particle-free air must be provided from a customer supplied compressed air source connected to the side hose barb of the mixing inlet.
- The original Nephele Mixing Inlet (only available via special order) required an adaptor to be used with some cascade impactors. New designs are now available for direct attachment to both the Andersen Cascade Impactor (Nephele II Mixing Inlet) and the Next Generation Impactor (Nephele III Mixing Inlet).
- All Nephele Mixing Inlets have a unique serial number to enable traceability.
The Nephele Mixing Inlet has been described in the following studies:
Mouth-Throat Models for Realistic In Vitro Testing - A Proposal for Debate
Bo Olsson, Per Bäckman
Respiratory Drug Delivery 2014 (2014), Vol 1, pp 287-294
Probing Dry Powder Inhaler Performance Robustness with an Inhalation Profile Simulator
Adrian Goodey, Buchilingam Bupathi, Henry Tat, Xiuhua Fang, Maya George, Ying Li
Respiratory Drug Delivery 2014 (2014), Vol 2, pp 485-488
In Vitro Aerosol Performances of NEXThaler® Using Representative Inhalation Profiles from Asthmatic Patients
Devis Casaro, Gaetano Brambilla, Irene Pasquali, Viviana Sisti
Respiratory Drug Delivery 2014 (2014), Vol 2, pp 375-380
- Validation of a General In Vitro Approach for Prediction of Total Lung Deposition in Healthy Adults for Pharmaceutical Inhalation Products.
Bo Olsson, Lars Borgström, Hans Lundbäck, Mårten Svensson
Journal of Aerosol Medicine and Pulmonary Drug Delivery, 2013 Feb 19
- Comparing Aerosol Size Distributions that Penetrate Mouth-Throat Models Under Realistic Inhalation Conditions
Bo Olsson, Elna Berg, Mårten Svensson
Respiratory Drug Delivery 2010 (2010), Vol 1, pp 225-234
- Realistic In Vitro Assessment of Dry Powder Inhalers.
Zhili Li, Richard N Dalby.
Respiratory Drug Delivery VIII (2002), Vol 2, pp 687-690
- Aerodynamic Sizing With Simulated Inhalation Profiles: Total Dose Capture and Measurement
Nicholas C Miller, M J Maniaci, Sarvajna K Dwivedi, Gary H Ward.
Respiratory Drug Delivery VII (2000), Vol 1, pp 191-196
Mixing Inlet Options
- NMI I: Original Nephele Mixing Inlet (Only available by special order)
- NMI II: Nephele II Mixing Inlet for Andersen Cascade Impactor
- NMI III: Nephele III Mixing Inlet for Next Generation Impactor
- NMI 001: Replacement seals for Original Nephele Mixing Inlet
- NMI 002: Replacement seals for Nephele II Mixing Inlet
- NMI 003: Replacement seals for Nephele III Mixing Inlet
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