{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T23:11:34Z","timestamp":1792105894433,"version":"4.4.0"},"reference-count":123,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2022,3,23]],"date-time":"2022-03-23T00:00:00Z","timestamp":1647993600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Children"],"abstract":"<jats:p>A major hurdle in pediatric formulation development is the lack of safety and toxicity data on some of the commonly used excipients. While the maximum oral safe dose for several kinds of excipients is known in the adult population, the doses in pediatric patients, including preterm neonates, are not established yet due to the lack of evidence-based data. This paper consists of four parts: (1) country-specific perspectives in different parts of the world (current state, challenges in excipients, and ongoing efforts) for ensuring the use of safe excipients, (2) comparing and contrasting the country-specific perspectives, (3) past and ongoing collaborative efforts, and (4) future perspectives on excipients for pediatric formulation. The regulatory process for pharmaceutical excipients has been developed. However, there are gaps between each region where a lack of information and an insufficient regulation process was found. Ongoing efforts include raising issues on excipient exposure, building a region-specific database, and improving excipient regulation; however, there is a lack of evidence-based information on safety for the pediatric population. More progress on clear safety limits, quantitative information on excipients of concern in the pediatric population, and international harmonization of excipients\u2019 regulatory processes for the pediatric population are required.<\/jats:p>","DOI":"10.3390\/children9040453","type":"journal-article","created":{"date-parts":[[2022,3,23]],"date-time":"2022-03-23T12:20:25Z","timestamp":1648038025000},"page":"453","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region"],"prefix":"10.3390","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4799-5562","authenticated-orcid":false,"given":"Jumpei","family":"Saito","sequence":"first","affiliation":[{"name":"Department of Pharmacy, National Center for Child Health and Development, Okura 2-10-1, Setagaya-ku, Tokyo 157-8535, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anjali","family":"Agrawal","sequence":"additional","affiliation":[{"name":"Drug Product Development, Bristol Myers Squibb, 181 Passaic Avenue, Summit, NJ 07901, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vandana","family":"Patravale","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai 400019, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anjali","family":"Pandya","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai 400019, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"Orubu","sequence":"additional","affiliation":[{"name":"Department of Biomedical Engineering, Boston University, 44 Cummington Mall, Boston, MA 02215, USA"},{"name":"Department of Pharmaceutics and Pharmaceutical Technology, Niger Delta University, Amassama 560103, Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7422-6710","authenticated-orcid":false,"given":"Min","family":"Zhao","sequence":"additional","affiliation":[{"name":"Medical Biology Centre, School of Pharmacy, China Medical University-Queen\u2019s University Belfast Joint College (CQC), Queen\u2019s University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gavin P.","family":"Andrews","sequence":"additional","affiliation":[{"name":"Medical Biology Centre, School of Pharmacy, China Medical University-Queen\u2019s University Belfast Joint College (CQC), Queen\u2019s University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Petit-Turcotte","sequence":"additional","affiliation":[{"name":"Therapeutic Products Directorate, Health Canada, Government of Canada, Ottawa, ON K1A 0K9, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Landry","sequence":"additional","affiliation":[{"name":"Office of Pediatrics and Patient Involvement, Health Canada, Government of Canada, Ottawa, ON K1A 0K9, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alysha","family":"Croker","sequence":"additional","affiliation":[{"name":"Office of Pediatrics and Patient Involvement, Health Canada, Government of Canada, Ottawa, ON K1A 0K9, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidefumi","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Research and Development Supervision, National Center for Child Health and Development, Tokyo 157-8535, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akimasa","family":"Yamatani","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, National Center for Child Health and Development, Okura 2-10-1, Setagaya-ku, Tokyo 157-8535, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Smita","family":"Salunke","sequence":"additional","affiliation":[{"name":"UCL School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,3,23]]},"reference":[{"key":"ref_1","first-page":"S10","article-title":"Developmental Changes in Pharmacokinetics and Pharmacodynamics","volume":"58","author":"Reed","year":"2018","journal-title":"J. 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