Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms

Abstract

Introduction: Most conventional drug delivery systems are not acceptable for pediatric patients as they differ in their developmental status and dosing requirements from other subsets of the population. Technology platforms are required to aid the development of age-appropriate medicines to maximize patient acceptability while maintaining safety, efficacy, accessibility and affordability.

Areas covered: The current approaches and novel developments in the field of age-appropriate drug delivery for pediatric patients are critically discussed including patient-centric formulations, administration devices and packaging systems.

Expert opinion: Despite the incentives provided by recent regulatory modifications and the efforts of formulation scientists, there is still a need for implementation of pharmaceutical technologies that enable the manufacture of licensed age-appropriate formulations. Harmonization of endeavors from regulators, industry and academia by sharing learning associated with data obtained from pediatric investigation plans, product development pathways and scientific projects would be the way forward to speed up bench-to-market age appropriate formulation development. A collaborative approach will benefit not only pediatrics, but other patient populations such as geriatrics would also benefit from an accelerated patient-centric approach to drug delivery.

Keywords: acceptability; age-appropriate; formulation development; oral drug delivery system; pediatric drug delivery; technology platform.

Figure 1.

A range of formulations and devices for age-appropriate oral drug delivery, which have emerged during the past two decades. Green triangles above: commercialized dosage forms and devices; Blue triangles below: non-commercialized dosage forms and devices. This is not intended to be an exhaustive list but exemplify progress.

Figure 2.

Schematic illustration of the nipple shield device (left) and image of a prototype device including drug delivery insert (right).

Figure 3.

Dose sipping technology: prototype straw containing granulated product with removable cap (left) and without cap, ready-to-use in a glass of water (right).

Figure 4.

Examples of orodispersible films in single-dose (left) and multiple-dose (right) packaging alternatives.