Abstract
The therapeutic options for coronal virus infections are limited. As SARS-CoV-2 directly targets the lungs and causes lung damage, treatment of COVID-19 with inhalants may offer more advantages over oral administration. Inhaled drug delivery provides a higher drug concentration in the target organ, where SARS-CoV-2 proliferates. In this study, we evaluated the potential systemic toxicity, relevant target organ toxicity, and toxicokinetics of Airnecflu®, Ultrapure, and Potent Tannic Acid (UPPTA) by metered-dose inhaler (MDI) inhalation to rodent and canine species once a day for 2 consecutive weeks. We further investigated the reversibility of the toxicity following a 3-week recovery period. No mortality related to the test article was observed in all the dose groups. Neither abnormalities related to the test article nor toxicologically significant changes were observed in both rodent and canine studies. In pathological examination, alveolar macrophage aggregation, perivascular/interstitial/alveolar inflammatory cell infiltration, and alveolar/bronchial epithelium hyperplasia were noted in the lung with bronchi involvement. However, after a 3-week recovery period, a substantial recovery was observed. There is limited systemic exposure to the inhalation administration. Therefore, inhalation of Airnecflu® UPPTA is safe to administer for respiratory disorders like COVID-19.
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