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 pediatric product is available on the market. Preliminary research confirmed that a slightly buffered, ion-pairing system 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.

Since HCQ is a Biopharmaceutics Classification System (BCS) Class 1 drug, the pharmacokinetics for an adult immediate-release formulation would not be altered by the creation of an embedded 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 that are weight-base dosed with HCQ.

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Elliott Pauli, Hemant Joshi, Anvit Vasavada, John Brackett

https://doi.org/10.1016/j.xphs.2019.12.014