• Publication Date: 04/01/2024
  • Author(s):
    Brooks, Clair Fenn, Matthew
  • Organization(s):
    Copley Scientific
  • Article Type: Technical Articles
  • Subjects: Devices and Components, Instruments, Nasal Delivery, Particle Characterization, Product Development/Formulation

This article describes the development and validation of the Alberta Idealised Nasal Inlet (AINI), illustrating its use within existing test set-ups. It also discusses three experimental studies that demonstrate: 1) the ability of the AINI to capture in vivo deposition behavior for different nasal drug products, 2) use of the AINI to assess and optimize formulations for intranasal vaccination, and 3) how the AINI enables more realistic assessment of the risk of pulmonary deposition.

Interest in intranasal drug delivery serves as a stimulus to improve in vitro test methods towards greater relevance and utility. The AINI serves several valuable purposes. Firstly, the Alberta Idealised Nasal Inlet (AINI) enables the in vitro assessment of regional deposition within the nose, for products in development. Secondly, the AINI is beneficial for generic developers seeking to replicate the performance of a reference product. Thirdly, by relevantly reflecting the dose captured in the nasal cavity, the AINI provides a more clinically representative assessment of the dose that might penetrate to the lung, relative to compendial nasal drug product testing apparatuses.

Download PDF