High Acceptability of an Orally Dispersible Tablet Formulation by Children

Abstract

There is a high unmet medical need for child-appropriate oral dosage forms. The acceptability of a novel placebo orally dispersible tablet formulation (pODT) was therefore evaluated. Monolithic tablets contain an inorganic calcium carbonate/calcium phosphate carrier material as the main excipient. They were assessed in a cross-sectional acceptability study. The 40 child participants were between 2 to 5 years and 6 to 10 years old. One pODT with 5 mm diameter was administered to each participating child by placement on the tongue or into the buccal cavity. Parents were asked to complete a questionnaire together with the study personnel. The spontaneous reactions of the children were recorded. The ease of administration and children’s acceptance of the tablet was rated by research staff on a 4-point acceptability scale and by parents on a 5-point Likert scale. The older subjects answered how they had liked the pODT by pointing to the appropriate face of a Facial Hedonic Scale. pODT had very high acceptability as 93% of parents, and all questioned children reported the formulation to be acceptable or very acceptable. Staff reported administering pODT in these children without problems. None of the children showed distress on receipt of pODT. We conclude that the proposed child-friendly dosage form provides a convenient option for oral drug administration and is expected to enhance drug-adherence in pediatric patients.

Calcium Phosphate Microcapsules as Multifunctional Drug Delivery Devices

“…Therefore, enhancing patient adherence and acceptability (i.e., children and geriatric patients). [ 19,21,22 ] The performance of the TIP‐ODTs prepared in this study was comparable to that of an oral lyophilisate. Disintegration data confirm that the particle geometry is responsible for the fast disintegration and not the chemical properties, as pure reference material has an entirely different water uptake capacity, contact angle, and disintegration time.…”

“…[19,20] Orally dispersible tablets (ODTs), made of FCC, have an excellent mouthfeel and are well accepted by children. [21,22] Moreover, concerning dosage form administration, solid dosage forms like tablets have several advantages over liquid dosage forms such as syrups. That includes chemical stability, accurate dosing, and taste masking, enhancing patient acceptance and compliance.…”

From paediatric formulations development to access: Advances made and remaining challenges

“…In addition, the reference lists of full‐text reviewed studies, systematic reviews 25,32 and review articles 26,27,33 were hand‐searched for potential citations. A total of 36 studies were reviewed and summarised in Tables 3–8 34–69 and are discussed in more details below. The unsystematic approach used in this review is a limitation.…”

“…A total of 312 children aged between 2 and 15 years have completed three studies evaluating the acceptability of ODTs in children (Table 6). 56–58 One involved a single placebo ODT 56 and two tested medicine‐containing ODTs, following a single dose of ondansetron ODT administered to children undergoing adenotonsillectomy 58 and after a 3‐week administration of an oral lyophilisate formulation of desmopressin in children with primary nocturnal enuresis 57 . Acceptability was measured by observation and/or questionnaires administered to research staff, caregivers and/or patients.…”

Drug Delivery Formulations and Devices Tailored for Paediatric and Older Patients

“…Virtually every route of delivery requires an adapted use of formulations and devices in neonates (Linakis et al, 2016) and paediatrics including parenteral through to nasal (Swedrowska et al, 2021), pulmonary (Arzu, 2021), oromucosal (Dahmash et al, 2021), and transdermal (Duarah et al, 2019). Recent examples of such efforts were the use of adapted nasogastric tubes to deliver crushed tablets to paediatric patients (Swedrowska et al, 2021) and an orodispersable tablet to improve patient adherence by avoiding the requirement to swallow a solid dosage form (Wagner-Hattler et al, 2021). There is therefore much to be done to better understand physiology in paediatric patients and to design formulations that allow accurate and convenient administration (Mfoafo et al, 2021).…”