Gvozdeva Yana, Staynova Radiana
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.
Children (Basel). 2025 Sep 5;12(9):1187. doi: 10.3390/children12091187.
: 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.
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。