Public Assessment Report for paediatric studies submitted in ...

2.4 Rectal Administration
Study BIO 75/9 „A comparison in children of the rectal absorption of salbutamol from Sultanol
suppositories and the oral absorption of salbutamol from Sultanol aerosol“. The study was carried out in
1975.
Study design - randomized, crossover, with 2 period/2 treatments, separate to wash-out period of
24 hours.
Study population - 10 healthy children.
Treatment - in the first day a blood sample was taken from the children as control.
- in the second day of the study, at 8,00 hour, was administered 1 suppository containing 2 mg
salbutamol and the blood samples were taken at 1, 4, 7 and 10 hours after dosing.
- in the third day, at 8,00 hour, 2 puffs ( 100µg/puf) of sulbutamol aerosol were given to the
cildren and a blood samples was taken 1 hour later.
Peak plasma concentration of salbutamol after puffs and suppositories administration was
measured by Gas cromatography – Mass Spectroscopy method.
Results
After administration of a suppository containing 2mg salbutamol, the peak plasma concentration
ranged from 4.0 to 12.3ng/ml was reached within 4 hours after treatment administration.
The plasma levels of salbutamol at 10 hours after dosing were from 0.8 to 3.2ng/ml.
The plasma salbutamol concentrations at one hour after treatment with 2 puffs of aerosol
containing 0.1mg salbutamol/puff were ranged from