Development and Validation of a Method to Quantify Midazolam in a New Oral Formulation for Pediatric Use

Carmen Flores Pérez, Juan Luis Chávez Pacheco, Janett Flores Pérez, Hugo Juárez Olguín, Blanca Ramírez Mendiola, Raquel García Álvarez, José Francisco González Zamora, Ángel Changin Guerra

Chocolates Turínò, S.A. de C.V..
Departamento de Anestesia y Quirófano, INP.
Laboratorio de Farmacología, Instituto Nacional de Pediatría (INP).

DOI: 10.4236/ajac.2012.38073                

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.

Keywords

Children; Liquid Chromatography; Magistral Formulation; Midazolam

Conflicts of Interest

The authors declare no conflicts of interest.

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