Improving the taste of pediatric medicines using flavor additives

Using Bitter Taste Receptor Blockers to Improve the Palatability of Pediatric Medicines: Trained Human Sensory Panels

This study is testing different flavor additives to see if they can make liquid medicines taste better for kids by having healthy adults taste and give feedback on the flavors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Monell Chemical Senses Center (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06929455 on ClinicalTrials.gov

What this trial studies

This research focuses on enhancing the palatability of liquid medications for children by testing various flavor additives. Healthy adult participants aged 18 to 60 will taste samples containing active pharmaceutical ingredients, such as tenofovir alafenamide and rifampicin, to evaluate their taste profiles. Participants will not swallow the samples but will provide feedback on the flavors. The goal is to identify ingredients that can make these medications more acceptable for pediatric patients.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 60 who can provide informed consent and attend multiple testing sessions.

Not a fit: Patients who are under 18, over 60, or have certain health conditions such as diabetes or liver issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this could lead to more palatable medications for children, improving adherence to necessary treatments.

How similar studies have performed: While there may be studies on taste improvement in medications, this specific approach using bitter taste receptor blockers is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Between the ages of 18 and 60;
* Generally healthy by self-report;
* All races/ethnicities, both men and women;
* Able to provide informed consent;
* Able to attend repeated visits to Monell for sensory testing;
* Willing to follow instructions (e.g., refrain from eating or drinking for at least 1 hour before sessions, willing to remain on site for one hour after tasting an API that the participant has never tasted before). -

Exclusion Criteria:

* Under 18 or over 60;
* Pregnant, nursing, or plans to become pregnant;
* Unable to provide consent (including limited ability to understand written and spoken English);
* Tobacco, vape, marijuana, or tetrahydrocannabinol cartridge users. We will accept people who have used tobacco or marijuana products on occasion, but not regular users;
* Known drug or food allergies of any kind;
* Diabetes or other metabolic disorder;
* Liver issues of any kind, including viral hepatitis;
* Kidney issues of any kind;
* Other chronic illness, including cardiovascular, neurological, immune disorders, or any other serious acute or chronic condition
* Dentures or other major dental implants;
* Condition affecting the oral cavity, including dry mouth, burning mouth syndrome, active sores or blisters, geographic tongue, or other disorders
* Current infection or cold, flu, or infection with SARS-CoV-2 within the last four weeks;
* Unable to taste or smell
* Daily use, or use within the last four weeks, of either prescription or over-the-counter medications (except for birth control)
* History of tuberculosis (including latent tuberculosis), positive skin or other tuberculosis test at any time in the past, birth in or residence in a country with high tuberculosis rates, known contact with someone who is tuberculosis positive
* HIV infection

Where this trial is running

Philadelphia, Pennsylvania

• Monell Chemical Senses Center — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Paul M Wise, Ph.D. — Monell Chemical Senses Center
• Study coordinator: Paul M Wise, Ph.D.

Conditions Healthy Adults