Features and Requirements of Non-clinical Toxic Evaluation of Inhalable Drugs

doi:10.19803/j.1672-8629.2021.06.16

Abstract

Abstract: Objective To analyze the features and requirements of non-clinical evaluation of inhalable drugs in order to provide reference for development of new inhalable drugs. Methods The characteristics of inhalable drugs were analyzed, such as generation of aerosols, dosimetry, reliability of the inhalation system, and interpretation of results. Factors that affected the non-clinical evaluation of inhalable drugs were identified so as to help design, conduct and analyze non-clinical experiments. Results The delivered dose of inhalable drugs was calculated, on the basis of which the deposited dose was estimated. During inhalation, the environmental parameters had to be monitored intensively. Inflammation in the upper airway was frequently noted due to the physiological and anatomical features of rodents. Aggregations of macrophages in the lung required cautious analysis. For inhalable biological drugs, the most common adverse reaction was inflammation. Conclusion The pharmaceutical properties of inhalable drugs place special demands on non-clinical evaluation.

Key words: inhalation, toxicity, non-clinical, particle size, aerosols, drugs

CLC Number:

R965.3

ZHANG Haifei, YU Shanshan, CAO Jin, ZHANG Tianzhu, WU Dongkai, NI Yike, ZUO Conglin, HU Xiaomin. Features and Requirements of Non-clinical Toxic Evaluation of Inhalable Drugs[J]. Chinese Journal of Pharmacovigilance, 2021, 18(6): 570-574.

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