Medicines for children: flexible solid oral formulations

Perspectives Children younger than five years old are generally unable to safely swallow solid capsules and tablets larger than 10 mm. 1 Although oral liquid medicines can be prescribed, these have some disadvantages over solid medicines. Substances or excipients that solubilize the active ingredient or ensure microbial stability are included in oral liquids and these may be harmful to young children. 2 Liquid medicines tend to be more expensive than solid medicines and this makes them less accessible to patients who pay for medicines out-of-pocket. Another problem is that liquid medicines are less chemically stable than solid medicines and require refrigeration in hot climates to guarantee their quality and efficacy. In countries where liquid formulations are not available, caregivers may manipulate solid medicines to make them easier to swallow, thus jeopardizing the quality, safety and efficacy of the medicine. These issues are a concern in global efforts to improve access to age-appropriate essential medicines for young children, especially in low-and middle-income countries. 3 The challenges of ensuring access to suitable medicines for children led the World Health Organization (WHO) in 2008 to propose flexible solid oral dosage forms as the preferred formulations for children. 4 These are solid forms that do not have to be swallowed whole, such as dispersible tablets, effervescent tablets, chewable tablets, orodispersible tablets and sprinkle capsules. These formulations potentially solve the problems of safety, cost and storage of liquid medicines. Better access to age-appropriate medicines is especially important for low-and middle-income countries, which have the highest burden of under-five mortality from preventable and treatable diseases. 5 However, the barriers to implementation of flexible solid oral dosage forms in these countries are not well understood. Three factors need to be considered: (i) country needs, (ii) local manufacturability, and (iii) acceptability to users. First, we need to know which oral medicines are currently available in easy-to-swallow forms. Knowledge of which new formulations are needed in low-and middle-income countries would help drive medicines' development. In 2014, a needs assessment was made in selected countries to determine which oral medicines in the WHO essential medicines list for children (3rd list, 2011) were available in age-appropriate forms. 6 Nigeria, as an ex-emplar lower-middle-income country, was compared with five high-income countries who are leaders in the production of innovative medicines. The commercial availability of flexible solid oral dosage forms and liquid forms was determined from each country's compendium of pharmaceutical products (Fig. …