Abstract

CHALLENGES IN PEDIATRIC FORMULATIONS DEVELOPMENT: A REVIEW

Ambadas R. Chikkale* and Rajesh Kumar Nema

Abstract

Drug formulations used in pediatric pharmacotherapy should be adapted to children‟s needs to suit their age, size, physiologic condition, and treatment requirements. Such pediatric medicines are keys to achieving safe and accurate dose administration, reducing the risk of medication errors, enhancing medication adherence, and improving therapeutic outcomes in children. The use of inadequate drug formulations in children may pose problems not seen in adults, such as difficulty in swallowing, safety issues with certain excipients that are acceptable in adult formulations and adherence problems with unpalatable medicines. Only a small fraction of all marketed drugs are available in formulations that are age appropriate and suitable for pediatric use. As a result, many adult medicines are used off-label in children, a practice that carries additional health and environmental risks. A number of innovative pediatric formulations have followed, but their actual effect on pediatric drug approvals remains to be seen, as clinical trials and marketing authorization take a substantial amount of time. To optimize pharmacotherapy in children, it is important for clinicians to understand the background of the aforementioned problems as well as to gain insight into the challenges, developments, and potential solutions. The aim of the present study was to describe specific challenges for pediatric drug formulations and to address the absence of adequate availability palatable formulations for children. We will discuss the major challenges in pediatric formulation and development, role of acceptable palatability in achieving adherence of pediatric population for pharmacotherapy and getting maximum outputs, the necessity of pediatric formulations and future steps.

Keywords: Pediatric Formulations, Challenges in Pediatric formulations.