Formulation Development and Evaluation of Hydroxyurea Dry Syrup for the Management of Pediatric Patients with Sickle Cell Disease in Tanzania

Abstract

Hydroxyurea (HU) is the drug of choice for the management of sickle cell disease but the available dosage form exists as a 500 mg capsule, which is not appropriate for pediatrics whose dosing requirements are 20 mg/kg. The current practice of compounding is prone to dose errors and contamination. Also, shortage of compounding laboratories in hospitals in the developing countries is a major issue. This study aimed at investigating the stability of HU in aqueous solution followed by formulation and evaluation of its dry syrup. Stability of HU aqueous solution was investigated and subsequently dry syrups formulated. They were evaluated for flowability, assay, dissolution, moisture content, rheology and pH. The formulated dry syrups complied with the United States Pharmacopeia (USP) specifications for stability, angle of repose (24-25°), assay (90-110%), dissolution (more than 85% in the first 30 minutes), shear thinning and pH (7.3). HU dry syrup was successfully developed, optimized and found to comply with USP specifications.