Ready-to-use oral solutions are highly sought-after dosage forms for pediatric use. They present a number of specific advantages over suspensions (dosage uniformity), powders for reconstitution (portability, ease of use) and solid forms (swallowability, dosing flexibility). However, the volumes that can be administered to the younger age groups of the pediatric population are limited (5-10 mL), which often precludes administration of the dose in one single administration, especially if the API is poorly soluble in the formulation. Other boundary conditions that complicate the development of a ready-to-use, oral solution-based pediatric formulations are the limitation in excipient selection (e.g. no preservatives), the requirement for taste-masking and the need for long-term chemical stability.
Our deep eutectic solvent formulation platform offers unique advanages to meet these stringent requirements for solution-based pediatric formulations. Our solvents have widely demonstrated utility to create high-payload solution formulations, even for the most poorly soluble APIs. In addition, our formulations are water-free, which generally avoids the need for preservatives, and highly tunable so that a chemical environment can be installed that guards the API against chemical degradation. Lastly, many sweeteners are highly useful excipients to create deep eutectic solvents (e.g. sucralose, saccharin or sorbitol). Usage of these excipients in our pediatric formulations assists in installing the right level of taste-masking.