Acceptability of Multiple Uncoated Minitablets in Infants and Toddlers: A Randomized Controlled Trial

Klingmann, Viviane; Linderskamp, Hannah; Meißner, Thomas; Mayatepek, Ertan; Moeltner, Andreas; Breitkreutz, Jörg; Bosse, Hans Martin

doi:10.1016/j.jpeds.2018.05.031

Cited by 54 publications

(50 citation statements)

References 11 publications

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“…5 There is increasing evidence to show that tablets are an acceptable dosage form and a suitable alternative to liquids which can overcome the challenges associated with liquid medicines. [6][7][8][9] The ability of CYP to swallow tablets is of importance to the pharmaceutical sector, healthcare professionals and patients themselves. The regulatory drive to develop ageappropriate formulations for children is hampered by the lack of empirical knowledge of the optimal tablet size for children of different ages.…”

Section: Open Accessmentioning

confidence: 99%

Can children swallow tablets? Outcome data from a feasibility study to assess the acceptability of different-sized placebo tablets in children (creating acceptable tablets (CAT))

et al. 2020

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ObjectiveFeasibility study to investigate the acceptability of different-sized placebo tablets in children aged 4–12 years.Design and settingClinical Research Facilities, inpatient wards and outpatient clinics within a Regional Paediatric Hospital and/or District General Hospital. Healthy children and National Health Service (NHS) patients were asked to swallow three placebo tablets: 6 mm, 8 mm and 10 mm, smallest to largest. The researcher observed children’s facial expressions and behaviours on swallowing and measured the volume of water consumed. Participants completed a questionnaire about the overall acceptability; including swallowability, taste and volume of water consumed. For analysis, participants were stratified by age: 4–8 years and 9–12 years.ResultsThe feasibility study led to an estimated recruitment rate of 0.8% for NHS inpatients and 211 healthy children over a 1-year period. In total, 55 participants were recruited, 30 to the younger group, of which 77% had never taken a tablet before. 84% of the 25 older children had previously taken a tablet. All participants attempted to swallow the smallest sized tablet. The children aged 4–8 years found the larger tablets easier to swallow, however the older children found little difference between the tablet sizes. The younger children required more water to swallow each tablet size compared with the older children where an increasing volume of water was consumed as tablet size increased. Taste was rated highly for both age groups. The 8 mm tablets were deemed the most acceptable tablet size by all participants.ConclusionTablets are potentially an acceptable formulation for children aged 4–12 years. Most children aged 4–8 years who attempted to swallow tablets successfully did so. Recruitment of NHS inpatients to medicine acceptability studies is challenging, however, recruitment of children of staff proved an effective strategy. Valuable lessons have been learnt from this feasibility study which will inform the design of a larger definitive trial.

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Section: Open Accessmentioning

confidence: 99%

Can children swallow tablets? Outcome data from a feasibility study to assess the acceptability of different-sized placebo tablets in children (creating acceptable tablets (CAT))

et al. 2020

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“…The other recent cross-over studies showed that even younger children (above the age of 6 months) can cope with swallowing a single 1 mm or 2 mm unit (9,10). The clinical trials performed in Germany confirmed, that even 25 units of minitablets (2 mm) are well-tolerated and safe in infants; moreover, children aged >1 year accept a large number of MT (= 400 units) even better than the equivalent dose of syrup (11). The up-to-date studies show that the administration of a larger number of minitablets to such small children may be possible with soft food (pudding, yogurt, mashed fruit mousse) or a drink (water, tea, fruit juice, lemonade, milk) of the childís choice.…”

Section: Pharmaceutical Technologymentioning

confidence: 89%

The Effect of Size of Enteric-Coated Minitablets and Type of the Dispersing Gel on the in Vitro Release of Diclofenac

Szczepanska¹,

Scanu²,

Sznitowska³

2020

Acta Poloniae Pharmaceutica - Drug Research

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Minitablets are small tablets (1-3 mm in diameter) that can be easily swallowed by children. When administered in a certain number of units they enable flexible dosing for a broad range of age in pediatric patients. They can be designed as a modified-release formulation. Administration of a larger number of minitablets to small children may be possible with a standard polymeric hydrogel which facilitates swallowing. Enteric-coated minitablets (2 and 3 mm) with diclofenac sodium were developed and the main goal was to evaluate how carbomer and sodium carmellose gels influence the in vitro drug release from minitablets. The cores of minitablets composed of microcrystalline cellulose, lactose, pregelatinized maize starch, sodium starch glycolate, colloidal silica and sodium stearyl fumarate were coated with Eudragit L. Not only enteric film thickness but also the size of minitablet cores had a critical significance for the release of diclofenac. Smaller minitablets (2 mm) with thinner film thickness (40 µm) released diclofenac in pH 6.8 buffer quickly, however, larger cores (3 mm) with the same film thickness swelled in the acidic medium and in effect very slow drug release in the buffer phase was observed. The application of a thicker film (60 µm) eliminated this problem. Mixing of minitablets with a carmellose gel caused a prolonged release of diclofenac in the buffer stage. This effect was largely reduced if a carbomer gel was used as a dispersing medium, but still, the drug release was slower than from loose minitablets or minitablets filled in a gelatin capsule.

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“…How to adduce evidence for such acceptability is shown below using the example of mini‐tablets with a diameter of 2 mm, which were administered to children in our children's university hospital. We focused our standardized assessment methodology on measuring acceptability including swallowability as defined and standardized in our studies because they have proven to be reliable parameters to objectively assess the suitability of oral formulations for children, resulting in recommendations for the most appropriate oral pediatric formulations. Based on the results of a pilot study with 60 children in 6 age groups aged from 6 months to 6 years, a confirmatory crossover study was conducted in 306 children in the same age groups with placebo coated and uncoated mini‐tablets in comparison to diluted 15% glucose syrup.…”

Section: Acceptability Of Drug Dosage Formsmentioning

confidence: 99%

Drug Formulations: Standards and Novel Strategies for Drug Administration in Pediatrics

Thabet

Klingmann

Breitkreutz

2018

The Journal of Clinical Pharma

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Child‐appropriate drug formulations are a prerequisite of successful drug therapy in children. Efficacy and safety must be given for the active pharmaceutical ingredient, but safety also for the used excipients, components of primary packaging materials, and devices. We are presently experiencing exciting times for pediatric drug development, stimulated by previous governmental incentives in both the European Union and the United States. The most important advances in pediatric drug formulation development are reviewed and evaluated in this article. Scientific publications and recent industry strategies indicate a clear shift from liquid dosage forms to novel solid dosage forms. Solid formulations are usually composed from excipients generally regarded as safe, whereas many liquid formulations contain excipients such as preservatives, antioxidants, or taste‐masking agents that raise concerns. Further, some recent clinical studies on swallowability, acceptability, and preference indicate superiority for small‐sized tablets, so‐called mini‐tablets, over conventional liquids. In general, multiparticulate solid dosage forms could partly replace the liquids and provide more stable and cheaper alternatives to existing drug products or new developments. Dispersible solid drug dosage forms like orodispersible tablets, mini‐tablets and films are even better opportunities for efficient and safe use in pediatrics. Novel measuring and administration devices may facilitate the handling and drug administration of these modern drug dosage forms. Combination products (drug‐device combinations) can easily be linked with new e‐health technologies in near future to further improve pediatric drug therapy.

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Acceptability of Multiple Uncoated Minitablets in Infants and Toddlers: A Randomized Controlled Trial

Cited by 54 publications

References 11 publications

Can children swallow tablets? Outcome data from a feasibility study to assess the acceptability of different-sized placebo tablets in children (creating acceptable tablets (CAT))

Can children swallow tablets? Outcome data from a feasibility study to assess the acceptability of different-sized placebo tablets in children (creating acceptable tablets (CAT))

The Effect of Size of Enteric-Coated Minitablets and Type of the Dispersing Gel on the in Vitro Release of Diclofenac

Drug Formulations: Standards and Novel Strategies for Drug Administration in Pediatrics

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