Evaluation of In Vitro Equivalence of Aerodynamic Particle Size Distribution of Levalbuterol Hydrochloride Inhalation Solution
Objective To study the aerodynamic particle size distribution(APSD)of Levalbuterol Hydrochloride Inhalation Solution,and evaluate the consistency of APSD between the test preparation and the reference preparation within the range required by the quality standard through population bioequivalence statistical test.Methods The APSD of Levalbuterol Hydrochloride Inhalation Solution was determined by next generation impactor(NGI),and the APSD consistency of the test preparation and the reference preparation with the content of 100％of the labeled amount and the test preparation and the reference preparation with the content of 85％,90％and 110％of the labeled amount were evaluated.Results Compared with the APSD indexes of the reference preparation,the test preparation met Hη＜0 in the content range of 90％-1 10％of the labeled amount,indicating that the test preparation was equivalent to the reference preparation.Conclusion The APSD determination method of Levalbuterol Hydrochloride Inhalation Solution is successfully established,which can provide a reference for the quality consistency evaluation of nebulized inhalation solution.
万方数据
维普
