DETERMINATION OF THE OPTIMAL COMPOSITION OF POWDER INHALATION FORMULATION

Introduction. A combination drug that contains salmeterol and fluticasone is widely used to treat asthma and chronic obstructive pulmonary disease. Medications as a powder for inhalation have a number of advantages over traditional aerosol methods, but their nomenclature in the Russian Federation is limited. Objective: to design the composition of a Russian combination inhaled drug formulation containing salmeterol and fluticasone. Material and methods. Experimental mixtures were prepared using two different brands of lactose carrier with various levels of micronized lactose. The mixture was prepared on a turbulent Hosokawa 1l mixer. The ready mixtures for blisters were packed using an Omnidose machine. Results. The effect of micronized lactose incorporated into the coarse lactose + salmeterol + fluticasone formulation was investigated before a respirable fraction was released. First of all, the lactose carrier substantially affected the release of the respirable fraction. The addition of micronized lactose increased the yield of a respirable fraction to a certain (maximum) value, after which it was observed to be reduced. Conclusion. The investigations have shown that that besides active substances, coarse lactose as a carrier and micronized lactose as an additive that improves the delivery of the drug substance should be added to the composition of the drug. The composition of the powder formulation, which complies with the optimality criterion, has been determined and the formulations that compare well with the reference drug Seretide have been chosen.