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Preparation and Evaluation of Levosalbutamol Sulfate-Ambroxol Hydrochloride Dry Powder Inhalation

??OBJECTIVE To select excipients and optimize preparation for the ambroxol hydrochloride/levosalbutamol sulfate dry powder inhalation. METHODS Drug and different excipients in the same ratio were prepared by spray drying to obtain a certain particle size as drug particles or carriers for dry powder inhalation, respectively. Study and compare the parameters of powders of the dry powder inhaler, such as the angle of repose, moisture content, and emptying rate, etc, to screen the excipient of the vectors. Afterward, Box-Behnken design method was adopted to optimize of preparation parameters. RESULTS When lactose-high branched cyclodextrin compounds were used as composite carriers, their powder properties meet the requirements of dry powder inhaler, such as the repose angle was 39.69 degrees, the bulk density was 0.37 g??mL^-1, the tap density was 0.66 g??mL^-1, the evacuation rate of drug-carrier powders in capsules was 93.12%, and the water content was 0.10% and the simulated lung deposition rate was 14.63%. The preparation parameters, such as sample concentration, inlet air temperature, nozzle diameter parameters, theirs values were 50 mg??mL^-1, 110 ??, 1 mm, respectively, were opmized by Box-Behnken design method, which could obtain the carrier particle size of 30.33 ??m. CONCLUSION Lactose-high branched cyclodextrin complexes can be used as carrier for levosalbutamol sulfate-ambroxol hydrochloride compound dry powder inhaler, which could meet the requirements of dry powder inhaler by spray-drying preparation method.