Minimum Dosing Frequency / End-User Needs
3.3 Minimum Dosing Frequency:
Parents and caregivers take care of the administration of medication to young children, whereas schoolchildren and adolescents can often manage their medication themselves. In both cases minimal dosing frequency should be aspired to. Instructions on the dosing frequency are based on the pharmacokinetic and pharmacodynamic properties of the API, but may be influenced by the design of
the dosage form.
Frequent dosing, i.e. more than twice daily, may have a negative impact on adherence to the dosing scheme both by caregivers and by older children, in particular when medicines are taken in settings where a trained caregiver is not available, e.g. at school. Moreover, frequent dosing may conflict with the lifestyle of older children.
3.4 End-User Needs:
In addition to maximizing the acceptability and palatability of paediatric medicines it is important that they are convenient to produce and affordable. It is also important to bear in mind supply-chain considerations, such as ease of transportation and storage requirements. It is not always possible for the user to store medicines in a refrigerator.
Depending on the age and clinical condition of the child, there are restrictions to the applicable dose volume or size. Generally, when developing the product, minimum dose volume and size should be the goal.
Lack of access to clean water is an important issue to take into consideration in the development of medicines that need to be dissolved, diluted or dispersed prior to administration, as it may compromise the quality of an FPP. It may be necessary to educate patients on how to obtain water of suitable quality, e.g. by supplying instructions on boiling or filtering. Provision of the liquid vehicle as a part of the package may be an option, or the dose may be dispersed or dissolved in a suitable food or beverage prior to administration. Some instructions on such use should be included on the label or package insert. Regional and cultural differences with regard to preferred tastes may need to be considered.
Development of Paediatric Medicines: points to consider in formulation,
(Annex 5, WHO Technical Report Series 970, 2012)
