Federal Register-67 FR 62171, White Chocolate, Establishment of a Standard of Identity, 2002. http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/RegulationsFederalRe- gisterDocuments/ucm189430.htm

has been cited by the following article:

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

  AUTHORS: 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

  KEYWORDS: Children; Liquid Chromatography; Magistral Formulation; Midazolam

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.3 No.8, August 27, 2012

  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.