Research And Application Of The Nose-only Inhalation Exposure System

With the growing development of the inhalation medication market,the nonclinical laboratory studiesof these kinds of drugs should be strengthened in order to provide relevant laboratory data for supporting the clinical usage.This article introduced the inhalation exposure system based on the OECD and domestic inhalation evaluation experimental guidelines.Meanwhile,taking drug BF018 which is used for the treatment of idiopathic pulmonary fibrosis(IPF)as an example,the nonclinical HPLC analysis method was validated with the linear range of 0.5～400μg/ml.Then the stable inhalation aerosol parameters were tested and studied,based on the actual work,the general procesure for searching these parameters werestudied and summried which would give inspirations for the nonclinincal inhalation exposure studies.Finally,the comparison studies between the inhalation and oral administration of BF018 in rats were performed.According to the results of the two dosingi methods,calculated by the same dose level,the ratios of drug concentration in plasma and lung tissues were 0.5 and 1.3 respectively.It might indicate certain kind of enhancing effect and reducing the adverse effect.Also,it provided the laboratory data and consideration for changing the BF018 oral formulation to inhalation formulation.