Table 1.
List of requirements for age-appropriate oral drug delivery systems.
| Benefit/risk | Criterion for drug product | Product requirements |
|---|---|---|
| Efficacy/acceptability | Dosage | Dose flexibility Acceptability of size/volume |
| Preparation/administration | Easy and convenient handling Easily administered (correct use) |
|
| Compliance | Minimal impact on lifestyle Acceptable appearance and taste Minimal administration frequency |
|
| Patient safety | Bioavailability | Adequate bioavailability |
| Excipients | Minimal number of excipients Tolerability |
|
| Stability | Stable during shell life Stable in-use |
|
| Medication error | Minimal risk of dosing error | |
| Patient access | Manufacturability | Robust manufacturing process Commercial viability |
| Affordability | Acceptable cost to patient and payers Easily transported and stored Low environmental impact |
Data taken from [9].