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Published on: November 9, 2016
Innovations in Pediatric Drug Formulations and Administration Technologies for Low Resource Settings
Stephen E Gerrard1, Jennifer Walsh2, Niya Bowers3
1Global Health and Global Development Divisions, Bill and Melinda Gates Foundation, Seattle, WA 98109, USA. Stephen.Gerrard@cantab.net.
Insights
Pediatric medicine development faces challenges, especially in low-resource areas, leading to unsafe adult drug use in children. Innovations like dispersible tablets offer solutions for better pediatric drug access.
Area of Science:
- Pediatric Pharmacology
- Global Health
- Pharmaceutical Development
Background:
- Despite regulatory efforts, a significant gap persists in developing age-appropriate medicines for children.
- Resource-poor regions face unique barriers, including disease burden, financial constraints, and fragmented healthcare systems, exacerbating this unmet need.
- The lack of approved pediatric formulations often leads to the off-label use of adult medications, increasing risks of incorrect dosing and adverse events.
Purpose of the Study:
- To provide an overview of the challenges in pediatric medicine development.
- To highlight shared and location-specific difficulties, opportunities, and innovative solutions.
- To discuss the potential of platform technologies for pediatric drug development in resource-limited settings.
Main Methods:
- Literature review and analysis of existing challenges in pediatric medicine development.
- Examination of regulatory landscapes and initiatives.
- Exploration of specific dosage forms and platform technologies relevant to low and middle-income countries (LMICs).
Main Results:
- Key difficulties in pediatric medicine development are identified across high and low-resource settings.
- Area-specific challenges, such as disease prevalence and economic factors, significantly impact formulation availability.
- Dispersible oral dosage forms and suppositories show promise for LMICs, alongside other emerging technologies.
Conclusions:
- Addressing the unmet need for pediatric medicines requires overcoming significant global and local challenges.
- Innovative approaches and accessible technologies are crucial for improving the availability and safety of pediatric medications, particularly in resource-limited environments.
- Further research and development into platform technologies are essential for advancing pediatric medicine accessibility worldwide.
Abstract:
Despite advances in regulations and initiatives to increase pediatric medicine development, there is still an unmet need for age-appropriate medicines for children. The availability of pediatric formulations is particularly lacking in resource poor areas, due to, for example, area-specific disease burden and financial constraints, as well as disconnected supply chains and fragmented healthcare systems. The paucity of authorized pediatric medicines often results in the manipulation and administration of products intended for adults, with an increased risk of mis-dosing and adverse reactions. This article provides an overview of the some of the key difficulties associated with the development of pediatric medicines in both high and low resource areas, and highlights shared and location specific challenges and opportunities. The utilization of dispersible oral dosage forms and suppositories for low and middle-income countries (LMICs) are described in addition to other platform technologies that may in the future offer opportunities for future pediatric medicine development for low resource settings.
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