ABSTRACT:
The aim of this study was to examine the influence of excipients on physical characteristics of combination dry powder inhaler formulation which contains salmeterol xinafoate (SX) and fluticasone propionate (FP). The formulation was prepared by Spray drying of micropariculate suspensions. The excipients used were a-lactose monohydrate and D-mannitol. Poloxamer 188 was used as a stabilizer. The powders generated were of a suitable size for inhalation with satisfactory yield. It was found that in optimum concentration with poloxamer 188; lactose and mannitol gave increased spray drying thermal efficiency. FTIR study showed the close agreement among the spectra of all spray dried formulations and APIs. Effect of excipients was further investigated by different physical characters of spray-dried formulations. The formulation was evaluated for in vitro drug release study by the modified USP II dissolution apparatus. Dissolution study gave immediate drug release profiles. The stability study indicated that all the formulations were quite stable at accelerated storage conditions. The results obtained from all observations indicate that in presence of poloxamer 188; mannitol was found to be superior over the lactose as an excipient; for the combination dry powder inhaler formulation containing salmeterol xinafoate and fluticasone propionate.