4. Particular Dosage Forms To Be Considered
4.1 Flexible Solid Dosage Forms:
Dosage forms that, in general, are likely to prove most suitable for global use, including for developing countries, and which should be prioritized, are flexible solid dosage forms such as tablets that are orodispersible and/or can be used for preparation of oral liquids suitable also for the younger age groups, e.g. dispersible and soluble tablets. The flexible dosage form design may be used for various APIs but may not be suitable for medicines requiring a precise dose titration.
Provided that the medicine can be dispersed in breast milk from the mother, it could potentially be used in very young children (< 6 months). When recommending mixing medicines with breast milk, the effect on the taste should be taken into account, as unpleasant tasting medicine may cause aversion in breastfed children. In addition, the compatibility of the API with breast milk will need to be considered. The same considerations apply whenever medicines are mixed with other food.
It is necessary to identify appropriate product strengths and ratios of active ingredients for each medicine as well as to ensure that package sizes will allow optimal use under public health programmatic conditions.
4.2 Oral Medicines:
For oral medicines that require precise dose measurement or titration, suitable dosage forms could be based on a platform technology to produce multiparticulate solids, e.g. mini-tablets or spherical granules (pellets), that allow production of dosage forms of varying strength as well as different dosage forms like tablets and capsules, and dosage forms to be dispersed to form a liquid dose or to be sprinkled onto food. Platform technology has potential flexibility for manufacturing appropriate fixed-dose combination products (FDCs). Breakable solid dosage forms specially designed to provide the appropriate dose may also serve the same purpose (1, 9).
4.3 Medicines For Severe Conditions:
For severe disease conditions, e.g. neonatal sepsis, the use of alternative dosage forms should be carefully considered. Some alternatives may be easier for untrained caregivers to administer, e.g. a rectal preparation or a spray under the tongue. For some conditions, parenteral formulations may be the best existing option; however, their use requires a trained caregiver.
4.4 Rectal Preparations:
As an alternative to parenteral preparations for severely ill children or children who are unable to swallow, the use of rectal preparations for indications of severe malaria, pain, infection and also nausea and vomiting may be appropriate. There may, however, be cultural barriers to the use of rectal preparations.
Development of Paediatric Medicines: points to consider in formulation,
(Annex 5, WHO Technical Report Series 970, 2012)
