High Acceptability of an Orally Dispersible Tablet Formulation by Children

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.

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or continue reading here: Wagner-Hattler, L.; Kiene, K.; Bielicki, J.; Pfister, M.; Puchkov, M.; Huwyler, J. High Acceptability of an Orally Dispersible Tablet Formulation by Children. Children 2021, 8, 194. https://doi.org/10.3390/children8030194

Conclusions
The evaluated placebo orally dispersible tablet based on insoluble carrier material was highly acceptable for administration to pre-schoolers and school-age children. It remains to be elucidated if multiple orally dispersible placebo tablets could be used as an alternative to multi-particulate granules or pellets. Future studies will focus on preparing palatable inert carrier ODTs for drugs that are currently available only as bad-tasting liquid formulations or are unavailable as child-friendly formulations. These include frequently used drugs, such as antibiotics and steroids. Greater use of this or similar child-appropriate solid oral formulations could improve access to high-quality medicines, enhance drug-adherence, and as such benefit millions of pediatric patients worldwide.

Materials and Methods
Placebo Orally Dispersible Tablets (pODT)
pODTs [13] with a diameter of 5 mm, containing FCC (OmyaPharm 500 OG, LOT OG/0001/53J; Omya, Oftringen, Switzerland), croscarmellose sodium (Ac-Di-Sol® SD 711NF; FMC International, Cork, Ireland), food-grade orange aroma (Givaudan, Vernier, Switzerland), citric acid (citric acid monohydrate; Carl Roth, Karlsruhe, Germany), sodium hydrogen carbonate (Hänseler, Herisau, Switzerland), and a cyclamate/saccharine mix (Sodium Saccharin/Sodium Cyclamate; Sanaro, Vouvry, Switzerland), were prepared by University of Basel, Division of Pharmaceutical Technology [10]. FCC is tasteless. Aroma and sweeteners were not added to mask the taste but to enhance palatability. In brief, granules for tablet manufacturing were produced by roller compaction (i.e., dry granulation) and subsequent blending. The composition of pODTs is provided as Supplementary Materials and is available from authors on request.