Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children

University Hospital, Basel, Switzerland40 enrolled

Overview

This is a cross-sectional study investigating the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) in children without underlying acute or chronic disease aged 2 to 10 years of age.

Oral dispersible tablets (ODTs) are a monolithic solid formulation potentially appropriate for a wide range of paediatric age groups. They also have a number of advantages over more frequently used formulation types, such as suspensions. Currently few Commercial products are available as ODTs for administration to children. Investigators aimed to investigate the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) by assessing overall parent-reported, observer-reported and, where appropriate, child-reported acceptance of the formulation. In addition, investigators assessed the in situ disintegration behaviour of the carrier tablet.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Oral dispersible tabletOTHER

Administration of a 5 mm calcium carbonate based ODT placed in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years).

Eligibility

Sex: ALLMin age: 2 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 2 and 10 years * Attending study site as an outpatient during the study period. * Informed consent form for study participation signed by legal guardian * Verbal assent to participation from child Exclusion Criteria: * Wearing dental braces * Injuries or inflammatory disease affecting the oral cavity or throat * Dysphagia * Olfactory impairment * Known renal impairment * Known hypercalcaemia, * Any known allergy against medications * Ongoing antibiotic treatment at the time of the study * Moderate-severe developmental delay as reported by the parents * Parents/legal guardians are unlikely to reliably complete structured questionnaire because of significant language barriers * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Previous enrolment into the current study

Locations (1)

UKBB

Basel, Switzerland

Outcomes

Primary Outcomes

Parent-reported palatability assessed by interview

5-point Likert scale, 1 "completely acceptable" to 5 "completely unacceptable"

Time frame: Day 1

Child-reported palatability (children aged 6-10 years only) assessed by interview

6-point Facial Hedonic Scale (0 "no discomfort on taking tablet" to 10 "maximum discomfort on taking tablet"

Time frame: Day 1

Secondary Outcomes

Observer-reported palatability assessed by questionnaire

4-point Likert scale (0 "child refuses to take tablet" to 4 "child proactively takes tablet")

Time frame: Day 1

In-situ disintegration behaviour of carrier tablet

Staff-observed disintegration of the tablet at 20, 40 and 60 seconds of placement

Time frame: Day 1

Data from ClinicalTrials.gov

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