Background As well as the global economic crisis resulting in drug shortages and reducing hospital budgets the demand for unlicensed drugs is increasing. Facing the increased demand and lack of an oral chloral hydrate dosage form for off-label, unlicensed and routine use in paediatric procedures we decided to solve this problem by strengthening compounding processes in our hospital pharmacy.
Purpose To develop appropriate and stable chloral hydrate dosage forms for paediatric use.
Methods Three batches of 4% and three batches of 10% chloral hydrate syrup were prepared. The syrups were packed and stored at room temperature (25°C) in 50 ml light-resistant glass bottles. Before dispensing to the hospital wards quantitative analysis (chemical tests and assays, USP 31st Ed) was performed of the chloral hydrate content in each batch. After the analysis half of each batch of syrup was dispensed to the wards and the rest were kept in the pharmacy for 3 months. Test samples were taken over the same time from syrups used on the wards and from syrups kept in our pharmacy for quantitative analysis of the chloral hydrate content.
Ingredients were: chloral hydrate, sucrose, Aetheroleum floris cariophylli (clove oil) and sterilised water.
Results Quantitative examinations of chloral hydrate in the series of samples indicated that the average content (99.8%) 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 found in any of the test samples.
Conclusions In the hospital pharmacy of Bitola Clinical Hospital, with a restricted drugs budget, we developed our own processes for two paediatric medicines: 4% Chloral hydrate syrup and 10% Chloral hydrate syrup. They are stable for at least 3 months and can be safely used within that period. Thus we solved many problems regarding drug supply, meeting the physicians’ requirements, satisfying patients and saving money at the same time.
No conflict of interest.
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