Convenient, Reliable Administration / Acceptability and Palatability
3.1 Convenient, Reliable Administration:
The administered dose should contain an amount of API adjusted to the age and needs of the child. The implication is that more than one dosage form of the API or more than one strength of a dosage form may be needed to cover different age groups. The intended dose volume or size should be appropriate for the target age group.
Paediatric medicines should preferably be presented as formulations that are ready to administer. The need for health professionals, parents or caregivers to manipulate the dose prior to administration should be kept to a minimum. However, there might be situations, depending on the formulation properties and the dose range to be covered, where this cannot be avoided.
Alternatively, to enable accurate dosing, the dosage form should be designed to subdivide into smaller, uniform doses of appropriate size and, for liquid forms, the dose volume should be accurately measured.
3.2 Acceptability and Palatability:
Acceptability is the overall acceptance of the dosage form regardless of the mode of its administration. Acceptability of a dosage form depends on a variety of factors such as:
■ Suitability of the dosage form for the particular age group
■ The dosing device used for a liquid medicine
■ Palatability of an oral medicine
■ Dose volume or size to be administered
■ Appropriateness of packaging
■ Clarity and accuracy of labelling information
■ Directions for use.
Acceptance of parents and caregivers is also a relevant issue, and the cultural setting may influence the understanding of and expectations of the therapy.
Palatability is the overall acceptance of the taste, flavour, smell, dose volume or size, and texture of a medicine to be administered by mouth or to be swallowed. Palatability can be crucial to adherence. Palatability of the API may influence the choice of dosage form and its design, which may include
taste-masking ingredients. The dosage form should not, however, be made too attractive to the child (e.g. it should not be in the form of a sugar-coated tablet resembling a sweet or candy) in order to avoid increasing the risk of accidental poisoning.
It is preferable that the dosage form is palatable in itself without any need for further modification. The caregiver may, however, attempt to improve the ease of administration and acceptance of the patient by mixing the dose with food or a beverage. Such mixing should not be encouraged unless it can be done
in such a small volume that ingestion of the full dose can be guaranteed and if there are no undesirable physical or chemical interactions between the food and the medicine. If mixing with food or a beverage (including breast milk) is foreseen, this eventuality should be evaluated by appropriate compatibility studies. Information should be provided in the patient information leaflet by the manufacturer, as supported by evidence-based studies.
Development of Paediatric Medicines: points to consider in formulation,
(Annex 5, WHO Technical Report Series 970, 2012)
