Favorable Acceptance of Mini-Tablets Compared with Syrup: A Randomized Controlled Trial in Infants and Preschool Children

Klingmann, Viviane; Spomer, Natalie; Lerch, Christian; Stoltenberg, Ines; Frömke, Cornelia; Bosse, Hans Martin; Breitkreutz, Jörg; Meißner, Thomas

doi:10.1016/j.jpeds.2013.07.014

Cited by 157 publications

(129 citation statements)

References 8 publications

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“…The age limit was further decreased in an exploratory study which demonstrated that children aged 6 to 12 months were capable of swallowing uncoated, drug-free, 2-mm mini-tablets and accepted them better than sweet liquid formulations. 120,121 For infants aged ,2 years, a new promising development is the orally disintegrating mini-tablet, which combines mini-tablets and fast-dissolving dosage forms. 111 A complementary research area is the development of pediatric dosing devices, which facilitate the accurate and consistent administration of oral pediatric formulations.…”

Section: Novel Oral Pediatric Formulationsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

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Children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is essential that pediatric medicines are formulated to best suit a child' s age, size, physiologic condition, and treatment requirements. To ensure adequate treatment of all children, different routes of administration, dosage forms, and strengths may be required. Many existing formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. New regulations, additional funding opportunities, and innovative collaborative research initiatives have resulted in some recent progress in the development of pediatric formulations. These advances include a paradigm shift toward oral solid formulations and a focus on novel preparations, including flexible, dispersible, and multiparticulate oral solid dosage forms. Such developments have enabled greater dose flexibility, easier administration, and better acceptance of drug formulations in children. However, new pediatric formulations address only a small part of all therapeutic needs in children; moreover, they are not always available. Five key issues need to be addressed to stimulate the further development of better medicines for children: (1) the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries; (2) a better use of existing data to facilitate pediatric formulation development; (3) innovative technologies in adults that can be used to develop new pediatric formulations; (4) clinical feedback and practice-based evidence on the impact of novel formulations; and (5) improved access to new pediatric formulations. Pediatrics

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Section: Novel Oral Pediatric Formulationsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

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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%

“…From an anthropological perspective, this may be instinctive; the importance of chewing food is widely reiterated to children and mastication before swallowing is an innate mechanism for articles which enter the mouth (Mrsny, 2012). The natural tendency to chew was evidenced in the recent studies assessing acceptability and swallowing of mini-tablets, especially amongst those aged 2 to 3 years old (Thomson et al, 2009, Klingmann et al, 2013. A large market research study found 285 that parents in the US predominantly preferred chewables over other oral dosage forms in children aged 1 to 15 years, while German parents showed a stronger preference for effervescent tablets and lozenges.…”

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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“…In summary, we have found that 4-mm uncoated mini-tablets can be used successfully in children from 1 year of age (46). In addition, Klingmann et al showed that smaller 2-mm minitablets can be used in infants from 6 months of age, whereas 2 mm rapidly dissolving mini-tablets can be used as early as in the pre-term age (47,48). These studies actually indicated that mini-tablets are equally or even better accepted than oral Table I.…”

Section: Mini-tabletsmentioning

confidence: 76%

Paediatric Drug Development and Formulation Design—a European Perspective

Riet‐Nales

Kozarewicz²,

Aylward

et al. 2016

AAPS PharmSciTech

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Abstract.The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed drug use are associated with a greater risk for harm than on-label drug use, a range of global initiatives have been developed to realize Bbetter^medicines for children. This review describes the challenges and achievements of the European Union to realize this goal, with a focus on paediatric drug development and formulation design. In 2007, a European Paediatric Regulation was installed enforcing companies to consider children in the early development of drugs with a new drug substance, for a new indication or with a new route of administration. The Regulation, e.g. requires companies to develop a paediatric investigation plan discussing the proposed clinical trials in children of different ages and the formulations for future marketing. Since 2013, the pharmaceutical design of any newly marketed paediatric drug should comply with the BGuideline on the Pharmaceutical Development of Medicines for Paediatric Use.^Companies should, e.g. justify the route of administration, dosage form, formulation characteristics, safety of excipients, dosing frequency, container closure system, administration device, patient acceptability and user information. In this review, the guideline's key aspects are discussed with a focus on novel formulations such as mini-tablets and orodispersible films, excipients with a potential risk for harm such as azo dyes and adequate user instructions.

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Favorable Acceptance of Mini-Tablets Compared with Syrup: A Randomized Controlled Trial in Infants and Preschool Children

Cited by 157 publications

References 8 publications

Pediatric Drug Formulations: A Review of Challenges and Progress

Pediatric Drug Formulations: A Review of Challenges and Progress

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

Paediatric Drug Development and Formulation Design—a European Perspective

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