Background Although no commercial products containing chloral hydrate are available in our country paediatricians are increasingly requesting oral and parenteral dosage forms. Facing that problem we set about compounding a rectal dosage form containing chloral hydrate for off-label, unlicensed and routine use in paediatric procedures.
Purpose To develop an appropriate and stable chloral hydrate formulation for rectal paediatric use.
Methods Three batches of 10% rectal emulsion were prepared and packed in both glass and plastic bottles. Before dispensing to the paediatric ward quantitative analysis (chemical tests and assays, USP 31st Ed) was performed of the chloral hydrate content in each batch. After the analysis, the preparations packed in glass bottles were dispensed to the ward. The preparations packed in plastic bottles were stored in a dark place in our pharmacy at room temperature (25°C) and kept for at least 3 months. We are still keeping them for further investigation of their stability and shelf life. Stability was defined as containing at least 95% of the initial concentration of chloral hydrate and absence of visible particles or/and colour and/or odour changes. Test samples were taken over the same time from preparations used on the wards and from those kept in our pharmacy and quantitative analyses of the chloral hydrate content were performed.
Ingredients used to compound this medicine were: chloral hydrate, Exp. Gummi arabicum and sterilised water.
Results Quantitative determinations of chloral hydrate in the series of samples on the same day of the production indicated that the average content (99.7%) of the active substance was within the acceptable concentration. The average concentrations in all test samples after 3 months of keeping or/and using (on the wards) were higher than 95% of initial chloral hydrate concentrations, indicating no significant loss of chloral hydrate. No visible particles or changes of colour and/or odour were detected in any test samples.
Conclusions In the hospital pharmacy of the Clinical hospital in Bitola we developed an appropriate formula and production process for 10% chloral hydrate rectal emulsion (for enema) that can be used for at least 90 days.
No conflict of interest.
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