{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T14:18:09Z","timestamp":1788013089386,"version":"build-2784847793"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T00:00:00Z","timestamp":1778630400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T00:00:00Z","timestamp":1778630400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2026,9]]},"DOI":"10.1007\/s43441-026-00985-1","type":"journal-article","created":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T17:06:08Z","timestamp":1778691968000},"page":"1367-1376","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluation of Ease of Use for Pediatric Medications Requiring Decapsulation, Dissolution, or Partial Dosing: A Questionnaire-Based Study in Japan"],"prefix":"10.1007","volume":"60","author":[{"given":"Jumpei","family":"Saito","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akimasa","family":"Yamatani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidefumi","family":"Nakamura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miki","family":"Akabane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,13]]},"reference":[{"key":"985_CR1","doi-asserted-by":"publisher","first-page":"563","DOI":"10.1016\/j.ijpharm.2017.07.042","volume":"536","author":"LA Buckley","year":"2018","unstructured":"Buckley LA, Salunke S, Thompson K, Baer G, Fegley D, Turner MA. Challenges and strategies to facilitate formulation development of pediatric drug products: safety qualification of excipients. Int J Pharm. 2018;536:563\u20139.","journal-title":"Int J Pharm"},{"key":"985_CR2","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1016\/j.ejpb.2021.04.011","volume":"164","author":"DCT Tan","year":"2021","unstructured":"Tan DCT, Khong YM, Mount S, Galella E, Mitra B, Charlton S, et al. Pediatric formulation development - challenges of today and strategies for tomorrow: summary report from M-CERSI workshop 2019. Eur J Pharm Biopharm. 2021;164:54\u201365.","journal-title":"Eur J Pharm Biopharm"},{"key":"985_CR3","doi-asserted-by":"publisher","first-page":"1728","DOI":"10.1016\/j.jpeds.2013.07.014","volume":"163","author":"V Klingmann","year":"2013","unstructured":"Klingmann V, Spomer N, Lerch C, Stoltenberg I, Fr\u00f6mke C, Bosse HM, et al. Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool children. J Pediatr. 2013;163:1728-32.e1.","journal-title":"J Pediatr"},{"key":"985_CR4","unstructured":"World Health Organization. (n.d.). TB Knowledge Sharing \u2013 5.3.3.2. Formulations. Available from: https:\/\/tbksp.who.int\/en\/node\/2175. Accessed 22 Nov 2025."},{"key":"985_CR5","unstructured":"World Health Organization. Policy brief. Transitioning to the 2021 optimal formulary for antiretroviral drugs for children: implementation considerations JULY 2021. Available from: https:\/\/iris.who.int\/server\/api\/core\/bitstreams\/f7b829d0-b57d-4109-9328-113401642293\/content. Accessed 20 Nov 2025."},{"key":"985_CR6","doi-asserted-by":"publisher","DOI":"10.1128\/aac.00014-15","author":"QB Bassat","year":"2015","unstructured":"Bassat QB, Djimde A, Stricker K, Hamed K. Tailoring a pediatric formulation of Artemether-Lumefantrine for treatment of Plasmodium falciparum malaria. Antimicrob Agents Chemother. 2015. https:\/\/doi.org\/10.1128\/aac.00014-15.","journal-title":"Antimicrob Agents Chemother"},{"key":"985_CR7","doi-asserted-by":"publisher","first-page":"e77","DOI":"10.1097\/INF.0000000000003729","volume":"42","author":"CM Yuen","year":"2023","unstructured":"Yuen CM, Sekadde MP, Kaiser B, Waning B, Graham SM. Towards shorter, child-friendly regimens for treatment of tuberculosis disease and infection in children. Pediatr Infect Dis J. 2023;42:e77\u20139.","journal-title":"Pediatr Infect Dis J"},{"key":"985_CR8","unstructured":"Revised WHO Classification and Treatment of Pneumonia in Children at Health Facilities: Evidence Summaries. Geneva: World Health Organization; 2014. Available from: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK264162. Accessed 20 Nov 2025."},{"key":"985_CR9","doi-asserted-by":"publisher","DOI":"10.3390\/children9020196","volume":"9","author":"J Saito","year":"2022","unstructured":"Saito J, Nakamura H, Walsh J, Yamatani A, Salunke S. A survey to understand parent\/caregiver and children\u2019s views on devices used for the administration of oral pediatric medicines in Japan. Children Basel. 2022;9:196. https:\/\/doi.org\/10.3390\/children9020196.","journal-title":"Children Basel"},{"key":"985_CR10","doi-asserted-by":"publisher","first-page":"249","DOI":"10.1016\/j.ijpharm.2014.03.053","volume":"469","author":"H Nakamura","year":"2014","unstructured":"Nakamura H, Ishikawa Y. How do Japanese children take their medicines, and what are pharmacists and paediatricians doing about it? Int J Pharm. 2014;469:249\u201350.","journal-title":"Int J Pharm"},{"key":"985_CR11","doi-asserted-by":"publisher","first-page":"843","DOI":"10.2147\/RMHP.S497454","volume":"18","author":"HK Ahtiainen","year":"2025","unstructured":"Ahtiainen HK, Lind\u00e9n-Lahti C, Heininen S, Holmstr\u00f6m AR, Schepel L. Introducing unit dose dispensing in a university hospital - effects on medication safety and dispensing time. Risk Manag Healthc Policy. 2025;18:843\u201354.","journal-title":"Risk Manag Healthc Policy"},{"key":"985_CR12","doi-asserted-by":"publisher","DOI":"10.1136\/ejhpharm-2024-004444","author":"M Gallina","year":"2025","unstructured":"Gallina M, Testagrossa M, Provenzani A. Unit dose drug dispensing systems in hospitals: a systematic review of medication error reduction and cost-effectiveness. Eur J Hosp Pharm. 2025. https:\/\/doi.org\/10.1136\/ejhpharm-2024-004444.","journal-title":"Eur J Hosp Pharm"},{"key":"985_CR13","doi-asserted-by":"publisher","first-page":"225","DOI":"10.3999\/jscpt.53.6_225","volume":"53","author":"M Suwa","year":"2022","unstructured":"Suwa M, Miyake S, Urushihara H. Comparison of regulations and status of promoting drug development and authorization of pediatric indications among Japan, the United States and the United Kingdom. Rinsho Yakuri. 2022;53:225\u201334.","journal-title":"Rinsho Yakuri"},{"key":"985_CR14","doi-asserted-by":"publisher","first-page":"336","DOI":"10.1007\/s43441-020-00218-z","volume":"55","author":"E Ueyama","year":"2021","unstructured":"Ueyama E, Kaneko M, Narukawa M. Analysis of pediatric drug approval lag in Japan. Ther Innov Regul Sci. 2021;55:336\u201345.","journal-title":"Ther Innov Regul Sci"},{"key":"985_CR15","doi-asserted-by":"publisher","first-page":"142","DOI":"10.1007\/s43441-024-00714-6","volume":"59","author":"R Osako","year":"2025","unstructured":"Osako R, Matsumaru N, Tsukamoto K. Pediatric-specific drug loss issue in Japan: comparison of pediatric development status between Japan and the United States. Ther Innov Regul Sci. 2025;59:142\u20139.","journal-title":"Ther Innov Regul Sci"},{"key":"985_CR16","doi-asserted-by":"publisher","first-page":"1335","DOI":"10.1016\/j.xphs.2018.11.013","volume":"108","author":"RG Strickley","year":"2019","unstructured":"Strickley RG. Pediatric oral formulations: an updated review of commercially available pediatric oral formulations since 2007. J Pharm Sci. 2019;108:1335\u201365.","journal-title":"J Pharm Sci"},{"key":"985_CR17","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1080\/17446651.2018.1455496","volume":"13","author":"J Porter","year":"2018","unstructured":"Porter J, Withe M, Ross RJ. Immediate-release granule formulation of hydrocortisone, Alkindi\u00ae, for treatment of paediatric adrenal insufficiency (Infacort development programme). Expert Rev Endocrinol Metab. 2018;13:119\u201324.","journal-title":"Expert Rev Endocrinol Metab"},{"key":"985_CR18","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1007\/s43441-021-00361-1","volume":"56","author":"J Saito","year":"2022","unstructured":"Saito J, Nakamura H, Yamatani A. Issues on powder forms for oral solution and suspension for pediatric patients in Japan: a questionnaire-based observational survey to pediatric pharmacists. Ther Innov Regul Sci. 2022;56:301\u201312.","journal-title":"Ther Innov Regul Sci"},{"key":"985_CR19","doi-asserted-by":"publisher","first-page":"1183","DOI":"10.2174\/1389450122999210120204248","volume":"22","author":"MS Handattu","year":"2021","unstructured":"Handattu MS, Thirumaleshwar S, Prakash GM, Somareddy HK, Veerabhadrappa GH. A comprehensive review on pellets as a dosage form in pharmaceuticals. Curr Drug Targets. 2021;22:1183\u201395.","journal-title":"Curr Drug Targets"},{"key":"985_CR20","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2016-0357","volume":"138","author":"HS Yin","year":"2016","unstructured":"Yin HS, Parker RM, Sanders LM, Dreyer BP, Mendelsohn AL, Bailey S, et al. Liquid medication errors and dosing tools: a randomized controlled experiment. Pediatrics. 2016;138:e20160357.","journal-title":"Pediatrics"},{"key":"985_CR21","doi-asserted-by":"publisher","first-page":"853","DOI":"10.1007\/s00431-023-05293-6","volume":"183","author":"BB Bal\u0131k\u00e7\u0131","year":"2024","unstructured":"Bal\u0131k\u00e7\u0131 BB, G\u00fcne\u015f \u00dc. Accuracy of liquid drug dose measurements using different tools by caregivers: a prospective observational study. Eur J Pediatr. 2024;183:853\u201362.","journal-title":"Eur J Pediatr"},{"key":"985_CR22","doi-asserted-by":"publisher","first-page":"534","DOI":"10.3390\/ph19040534","volume":"19","author":"R Paoli-Lombardo","year":"2026","unstructured":"Paoli-Lombardo R, Primas N, Tab\u00e9l\u00e9 C, Zaddam I, Iben Slimene E, Rathelot P, et al. Hard gelatin capsules compounded and dispersed in water in pediatrics: real versus theoretical dose administered. Pharmaceuticals. 2026;19:534.","journal-title":"Pharmaceuticals"},{"key":"985_CR23","doi-asserted-by":"publisher","first-page":"387","DOI":"10.3390\/pharmaceutics13030387","volume":"13","author":"K Rouaz","year":"2021","unstructured":"Rouaz K, Chiclana-Rodr\u00edguez B, Nardi-Ricart A, Su\u00f1\u00e9-Pou M, Mercad\u00e9-Frutos D, Su\u00f1\u00e9-Negre JM, et al. Excipients in the paediatric population: a review. Pharmaceutics. 2021;13:387.","journal-title":"Pharmaceutics"}],"container-title":["Therapeutic Innovation & Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-00985-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43441-026-00985-1","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-00985-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T13:47:00Z","timestamp":1788011220000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43441-026-00985-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,13]]},"references-count":23,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["985"],"URL":"https:\/\/doi.org\/10.1007\/s43441-026-00985-1","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,13]]},"assertion":[{"value":"3 February 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 May 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 May 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study was approved by the Ethics Review Committee of the National Center for Child Health and Development (Review Number: 2025-160), and was conducted in accordance with the Declaration of Helsinki. Participants provided electronic consent before completing the questionnaire.","order":1,"name":"Ethics","label":"Ethics Approval and Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Participants were informed during the consent process that the results of this research would be published.","order":2,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}]}}