This Funding Opportunity Announcement (FOA) encourages grant applications to address different and complementary research needs for the development and acceptability of pediatric drug formulations in different age groups. Development and testing of novel pediatric drug delivery systems is also part of this initiative.
Specific areas of research interest under this FOA include, but are not limited to, the following:
- Development of innovative technologies and platforms for oral pediatric formulations for poorly soluble drugs, unpalatable drugs, and for drugs requiring reconstitutable dosage forms. These technologies include taste masking and the use of novel excipients;
- Use of a materials science approach to overcome solubility limitations of pediatric drugs, increase bioavailability, decrease excipient exposure, and provide effective taste masking;
- Use of modeling and computational analysis of drug molecules and application of chemometric analysis to determine correlations with experimentally determined values of solubility, stability and taste and to establish the predictive value of computer simulations of new pediatric formulations;
- Development of animal models for taste assessment with comparison to electronic tongue, as well as more traditional sensory analysis in current use;
- Evaluation of methods in current use for taste testing in children including their validity and reliability;
- Development of standardized methods for testing drug formulations in pediatric and adult panels;
- Studies to evaluate the value of electronic tongue to quantify bitterness and taste masking efficiency in the development of pediatric formulations;
- Study of effect of different textures, granularity and smell of dosage forms in the acceptability of pediatric formulations;
- Application of theranostics in pediatrics;
- Determination of the reliability of the Biopharmaceutical Classification System in newborns and young infants;
- Study of the effect in infancy of the functional ontogeny of the gastrointestinal tract and of feedings on the dissolution, solubilization and absorption of different types of pediatric dosage forms;
- Development of methods to study efficacy of bitter blockers/maskers in reducing bitter taste and increasing acceptance;
- Performance of studies on cross-cultural flavor preferences and bitter taste sensitivity in children;
- Performance of psychophysical research on the chemical senses to determine what types of adult sensory panels and methods are most appropriate for predicting acceptance/compliance in the pediatric population;
- Performance of studies on excipients used in pediatric formulations, assessing interaction of excipients with drugs and with other excipients in different pediatric formulations;
- Development of non-invasive devices for evaluating adherence to chronic therapy in life- threatening conditions (e.g., HIV, diabetes, asthma, solid organ transplant patients);
- Development of novel approaches for oral mucosal, transdermal, nasal , ocular and pulmonary drug delivery systems and device technologies.
It should be noted that applications using the NIH R01 grant mechanism will require sufficient preliminary data to substantiate the validity of the proposed research and feasibility of new technologies or tools.