Articles and Resources
Learn more about the developments in paediatric medication and ODTs
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The challenges in paediatric medicines
Read moreChildren should not be treated as small adults. This is due to various factors including their growth and maturation, as well as the development of their organs, such as the liver which processes medicines. Children’s needs change as they develop (within the 0 – 18 year age range) and a medicine (formulation) should suit their specific needs at each developmental stage of their life.
Children have a low tolerance for unpleasant tastes, such that they may refuse to take certain medicines. Another important concern is ensuring that excipients (the other components that make up the medicine) are suitable for children. For example, some oral formulations contain ethanol or propylene glycol which can be toxic, particularly to premature babies.
Medicines need to be palatable and contain minimal excipients which are suitable in children. However, several other important factors should be considered; for example, the medication should be stable at room temperature, avoiding the need for refrigeration. It should also allow for flexible dosing and small dose increments (where appropriate).
Ivanovska, V., et al. (2014). Pediatric drug formulations: a review of challenges and progress. Pediatrics, 134(2), 361–372. Available from: https://doi.org/10.1542/peds.2013-3225
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Favourable acceptance of mini-tablets compared with syrup in children
Read moreSweet syrups are often considered to be the ‘gold standard’ for giving medicines to young children. However, liquid formulations may have limitations, including taste issues, inaccurate dosing and instability of the medicine in the liquid.
This article describes the results of three studies comparing 2mm diameter mini-tablets with sweet syrups in children of different ages. In the studies, the children were given mini-tablets and a small volume of sweet syrup. The children’s acceptance of, and ability to swallow each form was assessed. None of the mini-tablets or syrups tested in the studies contained medicines.
Mini-tablets had higher acceptability and swallowability than syrup in two studies conducted in 366 children aged 6 months to 6 years. Furthermore, the mini-tablets had similar acceptability and swallowability to syrup in a study of 151 young babies aged 2 to 28 days old.
Klingmann concluded that ‘mini-tablets are a new therapeutic alternative to liquid formulations for neonates, infants and preschool children to facilitate the administration of medicines’.
Klingmann, V., (2017). Acceptability of Mini-Tablets in Young Children: Results from Three Prospective Crossover Studies. AAPS PharmSciTech. Vol 18(2):263-266. Available from: DOI: 10.1208/s12249-016-0639-3.
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Favourable acceptance of mini-tablets in young babies
Read moreA study demonstrated that mini-tablets were more acceptable than syrup in children aged 6 months to 6 years. Given these positive findings, a study was conducted to assess the acceptability and swallowability of uncoated mini-tablets compared with syrup in 151 young babies aged 2 to 28 days old. Even in young babies, no difference was observed between the acceptability and swallowability of mini-tablets and syrup. Acceptability was 100% for both formulations. Swallowability was also high: 82.2% for mini-tablets and 72.2% for syrup. No babies inhaled the formulations or coughed during swallowing.
Klingmann et al. stated that:
- ‘Our results show that 1 mini-tablet may be safely administered even in neonates and that they actually swallow mini-tablets better than syrup.’
- ‘Our data close the age gap in current data referring to neonates and open the perspective for introducing such a small-sized solid drug formulations as a single formulation for all children including the very young, thus, further shifting the paradigm from liquid towards such small-sized solid drug formulations for children, as the World Health Organization proposes.’
Klingmann , V., et al. (2015). Acceptability of Uncoated Mini-Tablets in Neonates—A Randomized Controlled Trial. The Journal of Pediatrics. Vol 167(4): 893-96.e2. Available from: DOI: 10.1016/j.jpeds.2015.07.010.
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Current knowledge of orally dispersible formulations
Read moreProviding easily adjustable dosage forms for use in children can be challenging. Liquid formulations may have issues relating to taste, stability and the use of unacceptable excipients (the additional components that make up medicines) for children. Another method used is to crush tablets and mix these with foods or drinks, but again, there may be problems with stability, solubility, and acceptability by the child, and providing an accurate dose can be difficult.
This review article provides a summary of different orally dispersible (oral medicines which dissolve in the mouth) forms that are currently being developed to address dosing problems in children. Orodispersible granules, tablets, mini-tablets, freeze-dried tablets (lyophilisates) and films are discussed. Disadvantages of some of the orodispersible dosage forms are mentioned, such as problems with poor water solubility of certain orodispersible tablets. These issues may be overcome by using nanotechnology to make the particle size even smaller.
The article also points out that mini ODTs have additional benefits due to their size. With mini ODTs, the possibility to administer multiple units at a time allows for precise and flexible-dose control, without the need for manipulation (e.g. crushing), which is particularly advantageous when giving medicines to young children.
Cornilă, A., et al., (2022). Orally dispersible dosage forms for paediatric use: Current knowledge and development of nanostructure-based formulations. Pharmaceutics. Vol 14(8):1621. Available from: DOI:10.3390/pharmaceutics14081621.
INT-NON-24-0003 Date Updated: February 2024