Summary: At the European Pediatric Formulation Initiative (EuPFI) conference in 2023, Quotient Sciences partnered with Ardelyx, Inc. to present a collaborative study exploring the palatability of oral tenapanor formulations intended for pediatric use.
Titled “Taste Assessment Study of Tenapanor Pediatric Solution Formulations”, the poster was authored by a team that included Amit Sawant, Marcello DiMare, David Matusow, Susan Edelstein, Somasekhar Menakuru, and Vanessa Zann.
Read highlights from the poster below and download the poster to see additional findings.
Objectives of the clinical study
Tenapanor is a minimally absorbed sodium hydrogen exchanger (NHE3) inhibitor, approved in tablet form (IBSRELA®) for treating irritable bowel syndrome with constipation (IBS-C) in adults.
Ardelyx looked to develop an oral solution formulation to extend the therapeutic benefits of tenapanor to children aged 2–18, partnering with Quotient Sciences for pediatric formulation development and clinical taste assessment. The primary goal of the taste study was to evaluate taste acceptability of various formulations. A secondary objective was to assess specific taste attributes including sweetness, bitterness, and aftertaste.
Study design and methodology
The study looked to successfully identify the most palatable formulation for pediatric patients, accomplished through enrolling 14 healthy adult volunteers to participate in a controlled, randomized, “sip and spit” taste assessment. The study was conducted from Quotient Sciences – Nottingham, UK facility.
Each participant evaluated seven different tenapanor formulations, each containing 5 mg/mL of the active ingredient along with different sweeteners (sorbitol and sucralose) and flavors (strawberry and raspberry).
Participants then were asked to rate each formulation on a 9-point Likert scale for seven taste attributes, including overall acceptability, sweetness, and flavor. Quotient Sciences collected and analyzed the data to determine which formulation offered the best sensory profile.
Conclusions
The study concluded that formulations containing sucralose, sorbitol, or raspberry flavor—individually or in combination—are suitable candidates for further development in pediatric clinical studies.
Specifically, Regimen G, a combination of sucralose and raspberry flavor, achieved the highest scores across all taste attributes, showing a 2.0-point improvement in overall acceptability compared to the unsweetened/unflavored reference formulation.
Both sucralose and sorbitol improved taste acceptability when used alone, and the addition of raspberry flavor significantly enhanced the sensory experience.
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