The aim of this study was to investigate the dispersion and deaggregation o
f a model drug, salbutamol sulphate (SS), using lactose, mannitol or sorbit
ol as coarse and fine carriers. Binary and tertiary formulations containing
micronised salbutamol sulphate (SS) and sieved (63-90 mum) coarse sugar cr
ystals or salbutamol sulphate (SS) with a mixture of coarse and fine sugar
particles were prepared. Factorial design was employed to investigate the e
ffects of three variables, i.e. the chemical entity of the coarse sugar car
rier, the chemical entity of the fine sugar and the concentration of fine s
ugar, on the dispersion and deaggregation of salbutamol sulphate after aero
solisation at 60 l/min via a Rotahaler(R) into a twin stage liquid impinger
(TSI), The binary formulations containing the different sugar entities pro
duced differences in the fine (<6.4 <mu>m) particle fraction (FPF) of SS in
a decreasing order of mannitol > sorbitol > lactose, but failed to produce
efficient dispersion of SS since the FPF was < 10%. Adding fine sugar part
icles and increasing their concentration to the binary mixtures generally r
esulted in an increase in the FPF of salbutamol sulphate. The chemical natu
re of the fine carriers was found to play a less important role in determin
ing respirable fraction of the drug than the coarse carriers. In conclusion
, other sugars such as mannitol or sorbitol, besides lactose, may be employ
ed as coarse and/or fine carriers for incorporation into dry powder aerosol
Formulations to increase FPF. (C) 2000 Published by Elsevier Science B.V.