Formulations, excipients and acceptance issues

Solid oral dosage forms for children

The development of a drug product for the paediatric population has its specific challenges. The selection of the route of administration and the dosage form has to integrate therapeutic considerations, drug substance properties, technical feasibility and, above all, patient needs. Excipients require special scrutiny since tolerability in the paediatric population might be critical even if considered to be safe in adults due to the physiological differences [1]. The oral route of administration is the preferred one for children with liquid forms being favoured even though they are associated with some disadvantages, especially an unpleasant taste [2] (Julio/Agosto 2011).

Recently, the World Health Organization (WHO) therefore stressed the advantages of the solid dosage forms versus the liquid forms for the oral route of administration [3]. This article reviews solid oral dosage forms marketed for children and discusses their age-appropriateness and the suitability of the excipients used.

Excipients in paediatric medicines

Excipients are designated as inactive ingredients in medicines and should be safe for human use. However, excipients which are safe in adults could be critical for children, especially in newborns and infants due to their physiological characteristics and age-dependent maturation of organ function [2 y 4].
The EMA requires that excipients should be selected for the paediatric subpopulation with special care [5]. Often the use of solvents and surfactants is required to solubilise a poorly soluble drug. The addition of a buffering system, antioxidants, suspending agents and preservatives might be necessary to ensure stability. Flavours, sweeteners or polymers for film coating may be required to mask the unpleasant taste. For aesthetic reasons colouring agents might be used. Limitations in the type and amount of excipient often trigger a benefit- risk assessment.

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Palabras clave:  chewable tablets,   children,   excipients,   mini tablets,   multiparticulates,   oral wafers,   paediatric,   solid oral dosage, 

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