The need for pædiatric formulation: oral administration of nifedipine in children, a proof of concept

To administer individualised nifedipine doses to hypertensive children, Adalat retard 10 mg modified release (m/r) tablets are, in practice, cut if the child can swallow or crushed and suspend in water to produce a liquid formulation. We showed that the cutter used did not produce even halves or quarters tablets. Drug release and dissolution rate increased when tablets were cut into halves, quartered and crushed. The extemporaneous suspension (1 mg/ml) started to degrade after 15 min under light and it was difficult to withdraw targeted doses (1 and 5 mg) from this very unstable dispersion. Imported nifedipine drops (20 mg/ml) were easier to manipulate and provided more reproducible dosing although toxicity of the vehicle (magrogol 200) in children is unknown. This work illustrates the lack of appropriate paediatric drug formulations for children which is a rate limiting step for effective clinical use and for the development of optimal dose guidelines.