Safe use of Dexamethasone in pediatrics: design and evaluation of a novel stable oral suspension

Abstract

Background: Dexamethasone is used in pediatrics mainly for treatment of croup and bronchopulmonary dysplasia. Commercially available pediatric oral formulations include inadequate excipients for this population. When there are only commercially available oral dosage forms for adults, a formulation is prepared to reduce the dose by manipulation of authorized tablets or injectable dosage forms. This practice most of times is made without the quality and control that process requires. The aim of this study is to propose a formulation secure and suitable for pediatrics by the use of a Standard Operating Procedure that ensures its quality. Methods: Design of two formulations was performed with lowest number and amount of excipients suitable for pediatrics, avoiding use of dexamethasone salts and preservatives. An accurate and precise analytical method and a methodology for analyzing uniformity of doses were developed. Physical, chemical and microbiological stability was tested. Results: Stability of Dexamethasone was improved by acidification with citric/citrate buffer. Proposed suspension complies with quality criteria required for an oral non-sterile formulation using Dexamethasone as active pharmaceutical ingredient, and the minimum number and quantity of excipients suitable for pediatrics. Conclusions: This formulation is physical, chemical and microbiologically stable during 15 days storage at 5 and 25 °C.