Evaluation of an Immediate-Release Formulation of Hydroxychloroquine Sulfate With an Interwoven Pediatric Taste-Masking System.

Hydroxychloroquine sulfate (HCQ) is a quinoline used for the prevention and treatment of uncomplicated malaria, lupus erythematosus, and rheumatoid arthritis. For each indication, HCQ is an option for treatment of pediatric and juvenile patients on a weight basis; however, no tailored pediatric product is available on the market. Preliminary research confirmed that a slightly buffered, ion-pairing system significantly reduces the bitterness of HCQ, suggesting a high likelihood that a pediatric taste-masking system could be interwoven into an adult immediate-release formulation allowing the creation of a palatable suspension with water using common excipients. Because HCQ is a Biopharmaceutics Classification System Class 1 drug, the pharmacokinetics for an adult immediate-release formulation would not be altered by embeding a taste-masking system. Embedding the taste-masking and suspension agents within the adult tablet formulation would remove the need for aqueous-based vehicles and simplify the creation of a water-based suspension formulation to support improved compliance, dosing accuracy, and health outcomes in pediatric patients who are weight-base dosed with HCQ.