# In vitro atomization analysis and evaluation of inhalable sodium sivelestat formulations

## TL;DR

This study evaluates the in vitro atomization properties of a self-developed inhalable sodium sivelestat formulation and tests its therapeutic effectiveness in a mouse model of acute lung injury.

## Contribution

The study introduces a self-developed inhalable sodium sivelestat formulation and demonstrates its feasibility as an aerosol drug.

## Key findings

- Mesh nebulizers produce smaller and more uniform particle size distributions compared to air compressed nebulizers.
- The self-developed inhalable sodium sivelestat formulation showed therapeutic effects comparable to injection in a mouse model of acute lung injury.
- The atomization parameters of the formulation meet the requirements for inhalation drug delivery.

## Abstract

The purpose of this paper was to study in vitro atomization properties of the self-developed sodium sivelestat for inhalation, evaluate the feasibility of this preparation as an aerosol inhalation, and provide the guidance for the following animal administration experiment. Firstly, in order to ensure accurate, uniform and stable doses of the self-developed product after administration, its atomization performance was analyzed through the testing of fine particle mass and the total emitted dose, and the results of its atomization parameters meet the requirement of inhalation. Next, Atomization characteristics of two commonly used nebulizers, air compressed nebulizer and mesh nebulizer, were studied and compared. The results showed that mesh atomizers have a smaller and more uniform particle size distribution. And then, the experiment of acute lung injury induced by aerosol inhalation of lipopolysaccharide in mice was used to test the therapeutic effect of our self-developed formulation, and compared with the positive control (sodium sivelestat for injection). The results showed that inhalation had a lower concentration and was equally effective than injection of sodium sivelestat. All the results support that the self-developed sodium sivelestat can be used as an aerosol inhaled drug.