Description
Title: Pharmaceutical Excipients in Pediatric Patients: Current Situations, Issues, Current Efforts, and Future Prospects in Each Country and Region
Abstract: The lack of safety and toxicity information on some of the most frequently used excipients is a significant barrier in the development of pediatric formulations. In the adult population, the maximum oral safe dose for a variety of excipients is known; however, due to a lack of evidence-based data, the doses for pediatric patients, including preterm neonates, have not yet been established. This essay is divided into four sections: For ensuring the use of safe excipients, there are four parts to this study: (1) country-specific perspectives from various regions of the world (current situation, excipient challenges, and ongoing efforts), (2) comparison and contrast of the country-specific perspectives, (3) past and current collaborative efforts, and (4) future perspectives on excipients for pediatric formulation. Excipients used in pharmaceuticals are subject to a regulatory process. However, there are gaps between each region where it was discovered that there was a lack of information and an inadequate regulatory process. There are ongoing initiatives to raise awareness about excipient exposure, create a database specific to a given region, and improve excipient regulation; however, there is a dearth of evidence-based data regarding safety for the pediatric population. It is necessary to make more advancements in the areas of unambiguous safety limits, quantitative data on excipients of concern in the pediatric population, and global harmonization of excipients’ regulatory processes for the pediatric population.
Keywords: excipients; pediatric patients; age-appropriate dosage form
Paper Quality: SCOPUS / Web of Science Level Research Paper
Subject: Biology
Writer Experience: 20+ Years
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