The use of lactose recrystallised from carbopol gels as a carrier for aerosolised salbutamol sulphate.

Lactose was crystallised either from Carbopol gel without stirring or from a constantly-stirred aqueous solution, to obtain lactose crystals designated as Carbo and control lactose, respectively. The Carbo lactose was shown to have a more regular shape with smoother surface as compared with the control lactose. These lactoses were fractionated by sieving to produce batches with different sizes before blending separately with salbutamol sulphate (SS, VMD 5.8 microm) in a ratio of 67.5:1 w/w using the same mixing procedure. SS dispersion and deaggregation were investigated using a 4-stage liquid impinger after aerosolisation at 28.3, 60.0 and 96.0 l/min via a Rotahaler. At all flow rates, the Carbo lactose produced significantly higher (ANOVA, P<0.01) emission of SS from the Rotahaler as compared with the control lactose of a similar size. The Carbo lactose also resulted in a significantly (P<0.05) higher fine particle fraction of SS than the control lactose. Moreover, drug emission from formulations containing the Carbo lactose was consistently more reproducible than those of the control lactose blends. In conclusion, the efficiency and reproducibility of drug delivery by dry powder inhalers can be improved using carrier particles of precisely defined morphological features.