Age-appropriate solid oral formulations for pediatric applications with a focus on multiparticulates and minitablets: Summary of September 2019 EuPFI workshop

Harris, David R.; Hermans, Esmerald; Klein, Sandra; Wagner-Hattler, Leonie; Walsh, Jennifer

doi:10.1016/j.ejpb.2020.06.012

Cited by 22 publications

(18 citation statements)

References 10 publications

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“…In Japan, where the methods of administration used are different from those employed in Europe, fine granules are frequently used in addition to liquid formulations. However, no studies comparing the swallowability of these formulations with that of minitablets have been published [11]. Thereby, in 2019, we divided children aged 2-8 years into three age groups and compared the swallowability of multiple minitablets (2-4 years old: 6 tablets; 4-7 years old: 9 tablets; 7-8 years old: 12 tablets) with that of fine granules and liquid formulations [12].…”

Section: Introductionmentioning

confidence: 99%

Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study

et al. 2022

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Minitablets have garnered interest as a new paediatric formulation that is easier to swallow than liquid formulations. In Japan, besides the latter, fine granules are frequently used for children. We examined the swallowability of multiple drug-free minitablets and compared it with that of fine granules and liquid formulations in 40 children of two age groups (n = 20 each, aged 6–11 and 12–23 months). We compared the percentage of children who could swallow minitablets without chewing with that of children who could swallow fine granules or liquid formulations without leftover. The children who visited the paediatric department of Showa University Hospital were enrolled. Their caregivers were allowed to choose the administration method. In total, 37 out of 40 caregivers dispersed the fine granules in water. Significantly more children (80%, 95% CI: 56–94%) aged 6–11 months could swallow the minitablets than those who could swallow all the dispersed fine granules and liquid formulations (22%, 95% CI: 6–47% and 35%, 95% CI: 15–59%, respectively). No significant differences were observed in children aged 12–23 months. Hence, minitablets may be easier to swallow than dispersed fine granules and liquid formulations in children aged 6–11 months.

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Section: Introductionmentioning

confidence: 99%

Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study

et al. 2022

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“…Alternatively, multiparticulates can be presented in a bottle or other container that contains multiple doses. Depending on the properties of the formulation, multiparticulates can be placed directly in the mouth or mixed with soft foods and beverages 76 . The suitability of multiparticulates for taste‐masking and controlled release with film‐coating technologies 77 can translate into potential clinical benefits compared to liquid forms.…”

Section: Paediatric Oral Dosage Forms: Where Do We Stand?mentioning

confidence: 99%

“…Data supporting the capacity of children aged <6 months as well as that of sick hospitalised children to take multiparticulates are scarce and warrant further investigation. Also, as multiparticulates are usually administered with soft foods and beverages, there is a need for compatibility studies using these various food vehicles, which can be challenging 76 …”

Section: Paediatric Oral Dosage Forms: Where Do We Stand?mentioning

confidence: 99%

“…Minitablets have been proposed as a novel method of oral medicine delivery in children and are considered by some as the future of paediatric oral formulations 21 . They are compressed tablets typically ranging between 1 and 3 mm in diameter, 76,86 although there are no strict regulatory guidelines that define minitablets 21,87,88 (Figure 2). They provide some advantages over liquid forms with regard to medicine stability, storage conditions, taste‐masking and controlled release capacity 26,51 .…”

Section: Paediatric Oral Dosage Forms: Where Do We Stand?mentioning

confidence: 99%

“…The oral delivery of multiple minitablets per dosing can be achieved by packaging them in fixed dose strength sachet as for granules and pellets, with similar limitations regarding dosing flexibility. Another option is to rely on manual counting of minitablets by the caregiver, with the risk of counting errors and thus dosing errors 76 . Devices to count minitablets are under development.…”

Section: Paediatric Oral Dosage Forms: Where Do We Stand?mentioning

confidence: 99%

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

Litalien

Bérubé

Tuleu

et al. 2022

Brit J Clinical Pharma

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Developing suitable paediatric formulations and ensuring access to them by the greatest number of the 2.2 billion children worldwide are equally important to provide optimal pharmacotherapy. This review focuses on the progress made over the last two decades with paediatric oral formulations with respect to evidence for acceptability and dosing flexibility of liquid and solid oral dosage forms. It also discusses the clinical needs for, and the access to, paediatric formulations for existing authorised medicines. A significant body of new knowledge now supports the acceptability of solid oral dosage forms in children, resulting in an increasing number of medicines commercialised as multiparticulates, including minitablets that are starting to be brought to market. However, there are gaps with these formulations that deserve more research. Even though efforts have been made to identify medicines in need of age-appropriate formulations, there is no common priority list shared internationally. Such prioritisation would help to develop paediatric formulations with the greatest potential for providing a health benefit to children worldwide. In addition, available data highlight that paediatric formulation access is fragmented and unequal, with commercialisation of suitable paediatric formulations too often limited to some countries/regions. We propose actions to better align decisions during the development of paediatric formulations and promote a more globalised approach to facilitate registration pathways between different jurisdictions. Furthermore, discussions about alignment between approval, pricing and reimbursement processes should also happen, leaving working in siloes behind us. It is time for adults to start thinking outside the box for children.

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Evaluation of Tablet Splitting Methods: A Case Study of Propranolol

et al. 2021

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Age-appropriate solid oral formulations for pediatric applications with a focus on multiparticulates and minitablets: Summary of September 2019 EuPFI workshop

Cited by 22 publications

References 10 publications

Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study

Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study

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

Evaluation of Tablet Splitting Methods: A Case Study of Propranolol

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