Background In our country there are no authorised drugs for pre-procedural/preoperative sedation and anxiolysis in paediatric patients. As demand for such medicines has risen from the anaesthesiologists in our hospital we decided to produce an appropriate paediatric dosage form: midazolam HCl syrup.
Purpose To develop an appropriate and stable midazolam 3 mg/ml syrup.
Methods Three series of midazolam 3 mg/ml syrup were prepared. The syrups were packed and stored at room temperature (25°C) in 100 ml light-resistant glass bottles. Prior to dispensing the preparations to the Department of Anaesthesia, Resuscitation and Intensive Care, quantitative analysis, chemical tests and assays, (USP 31st Ed) of the midazolam HCl content were done. After the analysis half of the prepared quantity was dispensed to the above-mentioned department and the rest were kept in a dark place at room temperature (25°C) in our pharmacy for an indefinite period (we are still keeping them for further examinations). Test samples were taken periodically and at the same time from both the preparations dispensed and used on the ward and those kept in the pharmacy. Quantitative analysis of the midazolam HCl content was performed. Ingredients used for formulating this drug were: midazolam injectable sol. 5 mg/ml, vials of 10 ml, saccharose, Aetherolleum flora cariophylli (clove oil) and sterilised water.
Results Quantitative assays of midazolam HCl in the series of samples produced on the same day indicated that the average content of the active substance was higher than 99.80% i.e. within acceptable concentrations. The average concentrations in all test samples after 1 month (30 days) and 2 months (60 days) of keeping or/and using (on the wards) were higher than 95% of initial midazolam HCl concentrations. This indicates no significant loss (degradation) of midazolam HCl. Concentrations of midazolam HCl started to decrease under 95% of the initial concentration after the 68th day after the production date, so we withdrew the bottles dispensed to the wards. There were no visible particles or changes of colour and/or odour in the any of the test samples after 30, 60 and 90 days. The day on which the midazolam HCl concentration fell below 95% of initial value was the main criterion for the expiry date decision.
Conclusions In the hospital pharmacy of Bitola Clinical Hospital with a restricted drugs budget, we compounded a paediatric midazolam HCl 3 mg/ml syrup with an expiry date of 60 days.
No conflict of interest.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.