Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms
Felipe L Lopez1, Terry B Ernest2, Catherine Tuleu1
1a 1 University College London, School of Pharmacy, Department of Pharmaceutics , 29-39 Brunswick Square, London WC1N 1AX, UK felipe.lopez.13@ucl.ac.uk.
Insights
Developing age-appropriate medicines for pediatric patients requires specialized technology platforms to ensure safety and efficacy. Collaboration between regulators, industry, and academia is crucial for faster development and market access.
Area of Science:
- Pediatric pharmacology
- Drug delivery systems
- Pharmaceutical technology
Background:
- Conventional drug delivery systems are often unsuitable for pediatric patients due to unique developmental and dosing needs.
- Technology platforms are essential for creating age-appropriate medicines that are safe, effective, accessible, and affordable for children.
Purpose of the Study:
- To critically discuss current approaches and novel developments in age-appropriate drug delivery for pediatric patients.
- To highlight the importance of patient-centric formulations, administration devices, and packaging systems.
Main Methods:
- Review of current strategies in pediatric drug delivery.
- Discussion of novel technological advancements.
- Analysis of patient-centric formulations, devices, and packaging.
Main Results:
- Existing regulatory incentives and scientific efforts have not fully translated into licensed age-appropriate pediatric formulations.
- There is a significant need for the implementation of advanced pharmaceutical technologies.
Conclusions:
- Further implementation of pharmaceutical technologies is necessary for manufacturing licensed age-appropriate formulations.
- Harmonized collaboration among regulators, industry, and academia is key to accelerating the development of pediatric drug delivery systems.
- A patient-centric approach to drug delivery benefits not only pediatric populations but also other groups like geriatrics.
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.
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