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Safe and effective pharmacotherapy in infants and preschool children: importance of formulation aspects

Diana A van Riet-Nales1, Alfred F A M Schobben1, Herman Vromans2

  • 1Chemical Pharmaceutical Assessment (CFB), Medicines Evaluation Board in the Netherlands, Utrecht, The Netherlands Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands.

Archives of Disease in Childhood
|March 17, 2016
PubMed

Insights

Developing age-appropriate pediatric formulations, like mini-tablets, is crucial for safe and effective medication. Research shows specific mini-tablet types are suitable for neonates, infants, and young children, improving adherence.

Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Medicine
  • Drug Delivery Systems

Background:

  • Historically, a significant lack of suitable oral formulations for pediatric patients has hindered safe and effective pharmacotherapy.
  • Limited understanding existed regarding the impact of pharmaceutical characteristics on the age-appropriateness of pediatric medicines.

Purpose of the Study:

  • To review current knowledge on oral formulations for infants and preschool children.
  • To evaluate the advantages and disadvantages of various dosage forms for pediatric use.
  • To identify suitable age groups for different oral formulation types.

Main Methods:

  • Literature review of existing research on pediatric oral formulations.
  • Analysis of data on the efficacy and acceptance of different dosage forms in children.
  • Synthesis of information on formulation characteristics and age-appropriateness.

Main Results:

  • Rapidly dissolving 2 mm mini-tablets are suitable for preterm neonates.
  • Non-rapidly dissolving 2 mm mini-tablets can be used in infants from 6 months.
  • Uncoated 4 mm mini-tablets are appropriate for children from 1 year of age.
  • Children show a preference for mini-tablets over powders, suspensions, or syrups.
  • Novel formulations like orodispersible films offer additional treatment options.

Conclusions:

  • Mini-tablets represent a significant advancement in age-appropriate pediatric pharmacotherapy.
  • The selection of formulation type and size is critical for optimizing drug delivery in young children.
  • Further research into novel oral formulations will continue to enhance pediatric treatment possibilities.

Keywords:
administration, oralchildformulationmini-tablettehnology, pharmaceutical

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