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ZN-1

Single-dose disposable large volume dry powder inhaler

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With its expertise in 3D CAD-based reverse engineering, computational fluid dynamics (CFD) modeling and unique product design capability, zenius Ltd. has produced a prototype inhaler platform ZN-1, which holds strong USP of “patient-centric design”, “low cost” and “high drug delivery performance”. The equivalence in performance is utmost important when developing generic inhalers.

The ZN-1 platform is a platform for a large-volume dry powder inhaler for single inhalation and was developed for the generic Inavir (laninamivir octanoate): TwinCaps® powder inhaler, a therapeutic inhaler for influenza available in Japan, benchmarking to prove zenius’ capability in building low cost, user friendly generic DPI.

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ZN-1 Platform Features

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LOW UNIT PRICE

Single-dose, disposable device.

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ULTRA-LOW-COST MANUFACTURING

Smart assembly and filling.

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ENSURE PROPER PATIENT USE

Easy and intuitive to use.

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HIGH USABILITY

Ergonomic shape and large visible drug window.

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ALLOWS FOR A RANGE OF THERAPIES

Compatible to various carriers and formulations with volume.

Performance characteristics of ZN-1 platform

As a DPI platform of generics, ZN-1 has the same inhalation characteristics as the original product but has succeeded in reducing the variation in inhalation performance by stabilizing the air flow in the inhaler(the inhalati-

on error of the previous product was +/-0.2 l/min, but the variation was reduced to +/-0.02 l/min). In developing the device, zenius commissioned the performance evaluation to the laboratory of Virginia Commonwealth University (VCU) in the U.S. and were able to obtain the results showing equivalent performance (some excerpts of the test results follow).

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Comparisons of flow rate-dependent pressure drop and in vitro aerosol drug delivery performance between TwinCaps and ZN-1 inhalers. Data: mean±SD (n=3 or 5). (a) the pressure drop vs. inspiratory flow rate profiles; (b) laninamivir masses recovered from the inhaler (Inh), the mouthpiece adaptor (MpA), the USP induction port (IP), the preseparator (PS), and the NGI’s stage 1-7 (S1-S7) and micro-orifice collector (MOC) filter. *p<0.05 between the inhalers; (c) the % cumulative mass under size vs. aerodynamic diameter profiles.

ZN-1 replicates the airflow channel geometry of the TwinCaps ® inhaler but implemented design innovations to make it simpler to use and considerably less expensive to manufacture than its original by 20%, and based on CFD model analysis, it has been modified to generate a vortex flow of drug particles in the channel (see video).

How to use ZN-1

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Available for Partnering and License:

 - Single-use disposable large volume dry powder inhaler

 - Compatible with carrier and engineered formulations

 - Fully injection molded from 2 plastic components

 - Color and branding customization available

 - Transparent configuration for dose feedback to patient available

 - Available for Licensing, Supply and integrated Formulation-Device development

Credit

Team Lead:Masaki Fukushima

Design Lead:Masaki Fukushima

Designer:Hajime Nemoto

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