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Abstract
Aim: To develop an HPLC method to quantify midazolam in a new oral formulation for pediatric use. Methods: The stability of the new formulation was evaluated at different storage conditions and a preliminary assay of relative bioavailability was carried out in healthy volunteers. Results: The method of quantification was linear in the range of 5 to 60 μg·mL-1. The midazolam amount in the formulation remained stable for 90 days at 4 and 40℃ (in the dark) while at 25℃ was stable only for 14 days (exposed to light). Discussion: The relative bioavailability assay suggests that our preparation of midazolam in white chocolate reaches plasma levels similar to those induced by the apple juice formulation. Conclusion: This new white chocolate formulation masks the unpleasing flavour and has a more attractive presentation to the paediatric patient, which may be useful for children sedation and to ease its management by health carers.
Highlights
Drug prescription to pediatric patients is a serious problem in several circumstances: most medicines have been assayed and approved for adult use only; a great variety of drugs are neither available in an adequate paediatric formulation or in an appropriate dosage forms for children [1,2]
In recent years in our institution, about 40% of the patients submitted to ambulatory surgical procedures were administered with midazolam orally (I.V. solution) in apple juice; the use of such formulation has the disadvantage of having a sour and displeasing flavour and occasionally it is rejected by some patients
In the present work we assayed a midazolam oral formulation in white chocolate; this product contains at least 20% (w/w) of cacao butter and 3.5% (w/w) of milk fat, sugar (55%) and flavours [9]
Summary
Drug prescription to pediatric patients is a serious problem in several circumstances: most medicines have been assayed and approved for adult use only; a great variety of drugs are neither available in an adequate paediatric formulation or in an appropriate dosage forms for children [1,2]. Midazolam is a drug commonly prescribed to children, and it is a short-acting benzodiazepine employed for sedation and for induction of anaesthesia, due to its sedative, amnesic and anxiolytic effects [4]. This compound is available in 7.5 mg tablets and in 5, 15 and 50 mg midazolam hydrochloride injections. In recent years in our institution, about 40% of the patients submitted to ambulatory surgical procedures were administered with midazolam orally (I.V. solution) in apple juice; the use of such formulation has the disadvantage of having a sour and displeasing flavour and occasionally it is rejected by some patients. It has been reported that 0.5 mg·Kg–1 given orally has been the safest and more effective pre anaesthetic dose, and higher doses could induce adverse effects without offering further beneficial sedation [8]
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