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为儿科患者选择“理想”口服剂型:家长对儿童偏好的看法,重点关注口腔崩解片

Choosing the "Ideal" Oral Dosage Form for Pediatric Patients: Parents' Perspectives on Children's Preferences with a Focus on Orodispersible Tablets.

作者信息

Gvozdeva Yana, Staynova Radiana

机构信息

Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, Medical University of Plovdiv, 4002 Plovdiv, Bulgaria.

Research Institute, Medical University of Plovdiv, 4002 Plovdiv, Bulgaria.

出版信息

Children (Basel). 2025 Sep 5;12(9):1187. doi: 10.3390/children12091187.

DOI:10.3390/children12091187
PMID:41007052
Abstract

: Developing suitable dosage forms presents multiple challenges, such as ensuring the medication can be easily swallowed by young children, mixed with a small amount of food or liquid, and effectively taste-masked. There is no standardized guidance on pediatric dosage forms, taste preferences, or acceptable excipients, often resulting in costly delays due to required toxicology studies. Additionally, regulatory considerations around bioequivalence may necessitate further discussions between industry and regulatory authorities. : This research aimed to investigate and analyze Bulgarian parents' perspectives on their children's preferences regarding different oral dosage forms, with a particular emphasis on orodispersible tablets (ODTs). Additionally, challenges related to the development of age-appropriate formulations were comprehensively discussed. : A cross-sectional, online questionnaire-based study was conducted among 303 parents in Plovdiv, the second-largest city in Bulgaria, between January and March 2021. : The majority of parents (78.2%) reported no difficulties in administering medication to their child. Liquids were identified as the most preferred oral dosage form (68.3%), followed by tablets (21.8%). With respect to the importance of taste, most parents indicated that it is a very important factor influencing their child's acceptance of medication. Although 249 parents stated that they were familiar with ODTs, only 11.2% reported that their child had previously taken ODTs. : The results of our study show that the taste of the dosage form is a leading factor in child acceptability. The sweet fruit flavor was a favorite among children. Parental attitudes toward ODTs were strongly positive, with 91.1% indicating a preference for their child to receive ODTs rather than conventional tablets.

摘要

开发合适的剂型面临多重挑战,比如要确保药物易于幼儿吞咽,能与少量食物或液体混合,并且能有效掩盖味道。在儿科剂型、口味偏好或可接受的辅料方面,没有标准化的指导方针,这常常因所需的毒理学研究而导致代价高昂的延误。此外,围绕生物等效性的监管考量可能需要行业与监管机构之间进一步讨论。

本研究旨在调查和分析保加利亚父母对于其子女对不同口服剂型偏好的看法,尤其侧重于口腔崩解片(ODT)。此外,还全面讨论了与开发适合不同年龄段配方相关的挑战。

2021年1月至3月期间,在保加利亚第二大城市普罗夫迪夫对303名父母开展了一项基于在线问卷的横断面研究。

大多数父母(78.2%)表示给孩子喂药没有困难。液体剂型被认为是最受欢迎的口服剂型(68.3%),其次是片剂(21.8%)。关于口味的重要性,大多数父母表示这是影响孩子接受药物的一个非常重要的因素。尽管有249名父母表示他们熟悉口腔崩解片,但只有11.2%的父母报告称他们的孩子之前服用过口腔崩解片。

我们的研究结果表明,剂型的味道是孩子接受程度的一个主要因素。甜水果味最受孩子们喜爱。父母对口腔崩解片的态度非常积极,91.1%的父母表示更倾向于让孩子服用口腔崩解片而非传统片剂。

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本文引用的文献

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Pediatric oral extemporaneous preparations and practices: International Pharmaceutical Federation (FIP) global study.儿科口腔临时制剂和实践:国际药学联合会(FIP)全球研究。
Eur J Pharm Biopharm. 2024 Nov;204:114483. doi: 10.1016/j.ejpb.2024.114483. Epub 2024 Sep 6.
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Orodispersible Dosage Forms with Rhinacanthin-Rich Extract as a Convenient Formulation Dedicated to Pediatric Patients.以富含匙羹藤酸提取物的口腔崩解剂型作为一种适用于儿科患者的便捷制剂
Pharmaceuticals (Basel). 2024 Jul 27;17(8):994. doi: 10.3390/ph17080994.
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关于儿科药品研发监管领域的思考:现状与挑战简述
Front Pharmacol. 2024 Jun 3;15:1375988. doi: 10.3389/fphar.2024.1375988. eCollection 2024.
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Potentially Harmful Excipients: State of the Art for Oral Liquid Forms Used in Neonatology and Pediatrics Units.潜在有害辅料:新生儿科和儿科病房使用的口服液体剂型的现状
Pharmaceutics. 2024 Jan 17;16(1):119. doi: 10.3390/pharmaceutics16010119.
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Survey-based investigation into the current use of paediatric medicines and administration devices in China.基于调查的中国儿科药物和给药装置使用现状研究。
Eur J Pharm Biopharm. 2023 Oct;191:290-302. doi: 10.1016/j.ejpb.2023.09.006. Epub 2023 Sep 7.
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Dosage Forms Suitability in Pediatrics: Acceptability of Analgesics and Antipyretics in a German Hospital.儿科剂型适用性:德国一家医院中镇痛药和解热药的可接受性
Pharmaceutics. 2022 Jan 31;14(2):337. doi: 10.3390/pharmaceutics14020337.
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A Survey to Understand Parent/Caregiver and Children's Views on Devices Used for the Administration of Oral Pediatric Medicines in Japan.一项旨在了解日本家长/照顾者及儿童对口服儿科药物给药设备看法的调查。
Children (Basel). 2022 Feb 3;9(2):196. doi: 10.3390/children9020196.
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Paediatric specific dosage forms: Patient and formulation considerations.儿科专用剂型:患者和剂型考虑因素。
Int J Pharm. 2022 Mar 25;616:121501. doi: 10.1016/j.ijpharm.2022.121501. Epub 2022 Jan 29.
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Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics.迷你片剂:儿科中兼顾疗效与安全性的有效策略。
Pharmaceuticals (Basel). 2022 Jan 17;15(1):108. doi: 10.3390/ph15010108.
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Orodispersible tablets for pediatric drug delivery: current challenges and recent advances.用于儿科药物传递的口崩片:当前的挑战和最新进展。
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