Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children

Version 1 : Received: 5 August 2020 / Approved: 6 August 2020 / Online: 6 August 2020 (12:00:05 CEST)

A peer-reviewed article of this Preprint also exists.

Katarzyna Hofmanová, J.; Bennett, J.; Coupe, A.; A. Bartlett, J.; Monahan, A.; Batchelor, H.K. A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children. Pharmaceutics 2020, 12, 806. Katarzyna Hofmanová, J.; Bennett, J.; Coupe, A.; A. Bartlett, J.; Monahan, A.; Batchelor, H.K. A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children. Pharmaceutics 2020, 12, 806.

Journal reference: Pharmaceutics 2020, 12, 806
DOI: 10.3390/pharmaceutics12090806

Abstract

The popularity of multiparticulate formulations (MPs) as a paediatric dosage form continues to increase. MPs comprise of multiple small units that are easy-to-swallow. Currently, MPs are commonly manufactured into unit doses that are either swallowed whole or opened prior to administration. While this is an acceptable approach, dosing is envisioned to be optimized with a ‘standard’ paediatric device which can better harness the flexible dosing potential of MPs. We evaluated a novel oral syringe (SympfinyTM) that is being developed as a tool to dispense and administer MPs to children. Forty children, 4-12 years old, received 0.5, 1.2, and 2.0 mL doses of placebo MPs using the oral syringe with spring water or a drink of choice to complete sample intake. Acceptability was recorded as those able to completely swallow the dose and participants also rated dose acceptability on a 5-point scale. The ability to completely swallow the dose decreased as dose volume increased; the smallest dose was completely swallowed by 87.5% (35/40) children, and 69.4% (27/39) of children confirmed their willingness to take the sample as a daily medicine. Larger doses, 1.2 and 2.0 mL, gave values of 55% and 57.5% for the doses completely swallowed and 58.8% and 51.72% for willingness to take the sample as a daily medicine, respectively. Use of a drink of choice showed no increase in swallowability as compared with water. The novel oral syringe being developed is an appropriate device for dispensing doses flexibly and administering neutral tasting MPs directly to the mouth in the lower dose range without the need for a co-administration vehicle in children aged 4-12 years.

Subject Areas

multiparticulates, administration device, acceptability, paediatric formulation, mouthfeel, oral syringe

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