Can preschool-aged children swallow several minitablets at a time? Results from a clinical pilot study

Kluk, Anna; Sznitowska, Małgorzata; Brandt, Agnieszka; Sznurkowska, Katarzyna; Plata-Nazar, Katarzyna; Myśliwiec, Małgorzata; Kamińska, Barbara; Kotlowska, Hanna

doi:10.1016/j.ijpharm.2015.02.068

Cited by 70 publications

(57 citation statements)

References 12 publications

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“…In both cases, child acceptability may change in comparison to the administration of a single mini-tablet. Recently, Kluk et al (2015) have studied the swallowability of five to ten 2-mm and 3-mm tablets that were administered on a spoon with fruit gel to children aged two to three years old in an institutional setting. The results showed that children could swallow these numbers of mini-tablets safely (Kluk et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

“…Recently, Kluk et al (2015) have studied the swallowability of five to ten 2-mm and 3-mm tablets that were administered on a spoon with fruit gel to children aged two to three years old in an institutional setting. The results showed that children could swallow these numbers of mini-tablets safely (Kluk et al, 2015). Nevertheless, the acceptability of several mini-tablets of different sizes, in children of different ages and in different settings remains subject to further investigations.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Methods of administering oral formulations and child acceptability

Riet‐Nales

Ferreira

Schobben

et al. 2015

International Journal of Pharmaceutics

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Methods of administering oral formulations and child acceptability

Riet‐Nales

Ferreira

Schobben

et al. 2015

International Journal of Pharmaceutics

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“…Recent studies assessing the acceptability and swallowability of placebo mini-tablets have been a notable emergence in the field, particularly as a dosage form for neonates and infants (Klingmann et al, 2013, Klingmann et al, 2015, Thomson et al, 2009, van Riet-Nales et al, 2013, Kluk et al, 2015. An important objective of 235 the CALF study was to determine acceptability and perceptions of these dosage forms in older children, since very little is reported in the literature.…”

Section: Novel Dosage Formsmentioning

confidence: 99%

Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children’s Acceptability of Oral Formulations (CALF) Study

Ranmal¹,

Cram

Tuleu³

2016

International Journal of Pharmaceutics

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A lack of evidence to guide the design of age-appropriate and acceptable dosage forms has been a longstanding knowledge gap in paediatric formulation development. The Children's Acceptability of Oral Formulations (CALF) study captured end-user perceptions and practices with a focus on solid oral dosage forms, namely tablets, capsules, chewables, orodispersibles, multiparticulates (administered with food) and mini-tablets (administered directly into the mouth). A rigorous development and testing phase produced age-adapted questionnaires as measurement tools with strong evidence of validity and reliability. Overall, 590 school children and adolescents, and 428 adult caregivers were surveyed across hospitals and various community settings. Attitudes towards dosage forms primarily differed based on age and prior use. Positive attitudes to tablets and capsules increased with age until around 14 years. Preference was seen for chewable and orodispersible preparations across ages, while multiparticulates were seemingly less favourable. Overall, 59.6% of school children reported willingness to take 10mm diameter tablets, although only 32.1% of caregivers perceived this size to be suitable. While not to be taken as prescriptive guidance, the results of this study provide some evidence towards rational dosage form design, as well as methodological approaches to help design tools for further evaluation of acceptability within paediatric studies.

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“…However, it has been already proved that even children in the age of 6 months are able to swallow a single uncoated 2‐mm minitablet . It was also demonstrated that the preschool children (2–3 years old) are able to swallow several minitablets (5–10 units) at a time, making the idea of administering minitablets in multiple unit dosage forms (MUDFs) to children plausible …”

Section: Introductionmentioning

confidence: 99%