Establishment of a performance verification method for oral and nasal inhalation system under GLP conditions
Objective To establish a method to verify the performance of a Oral and nasal Inhalation System under GLP conditions.Methods Combining the testing parameters and concerns of the inhalation system in the literature related to the inhalation tests,and then combining the instrument factory performance standards,the performanceevaluation of the oralnasal inhalation system is established based on the precise aerosol inhalation system.The validation includes system pressure,inlet flow reliability,exposure concentration homogeneity,and exposure system stability.Results The system pressure deviation was-1.52%～1.00%.The CV of the system intake flow was within the range of-1.84%to 3.40%.The RSD between the exposed concentration pores for liquid inhalation administration was 7.70%,while the RSD between the exposed concentration pores for powder inhalation administration was 15.75%.Continuous atomization for 30 minutes,liquid exposure concentration RSD was 5.50%,powder exposure concentration RSD was 7.22%,temperature,humidity,O2 concentration,CO2 concentration were all within the qualified standard range,Under the test conditions in our laboratory,the performance parameters of the Nose-Only inhalation exposure System for Rodents and Canines were in accordance with the technical requirements of the Manufacturer's standard.Conclusion The above method is accurate and reliable,and can meet the needs of drug safety evaluation.It can provide a useful reference for the performance verification of Oral and nasal Inhalation System under GLP conditions.
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