Formulation and in Vitro Evaluation of Chloral Hydrate Rectal Suppositories for Paediatric Use

Chloral hydrate (CH) is a short-term sedative and hypnotic normally given to children as a syrup to assist with sleep and alleviate anxiety prior to painful dental or medical procedures which entail the patient to be still (e.g. scans and EEGs) [1, 2]. However, when given orally, it exhibits a bitter taste and the most common adverse reaction shown is gastric irritation. Moreover, the onset of reaction occurs about 30 minutes after oral dosing, delaying the observation of the sedative and hypnotic effect [1]. Since observation of the therapeutic effect is known to be faster by the rectal route of administration and this route would also overcome taste and gastric irritation problems, rectal suppositories, especially useful for treating young patients, were deemed as appropriate alternative dosage forms. The aim of this study was the formulation and in vitro evaluation of a rectal suppository dosage form of CH intended for paediatric use in a local hospital. A strategy for prolonged drug release of selected formulations was also assessed.