Januskaite Patricija, Xu Xiaoyan, Ranmal Sejal R, Gaisford Simon, Basit Abdul W, Tuleu Catherine, Goyanes Alvaro
Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
FabRx Ltd., 3 Romney Road, Ashford, Kent TN24 0RW, UK.
Pharmaceutics. 2020 Nov 17;12(11):1100. doi: 10.3390/pharmaceutics12111100.
3D printing (3DP) in the pharmaceutical field is a disruptive technology that allows the preparation of personalised medicines at the point of dispensing. The paediatric population presents a variety of pharmaceutical formulation challenges such as dose flexibility, patient compliance, taste masking and the fear or difficulty to swallow tablets, all factors that could be overcome using the adaptable nature of 3DP. User acceptability studies of 3D printed formulations have been previously carried out in adults; however, feedback from children themselves is essential in establishing the quality target product profile towards the development of age-appropriate medicines. The aim of this study was to investigate the preference of children for different 3D printed tablets (Printlets™) as an important precursor to patient acceptability studies. Four different 3DP technologies; digital light processing (DLP), selective laser sintering (SLS), semi-solid extrusion (SSE) and fused deposition modeling (FDM) were used to prepare placebo printlets with similar physical attributes including size and shape. A single-site, two-part survey was completed with participants aged 4-11 years to determine their preference and opinions based on visual inspection of the printlets. A total of 368 participants completed an individual open questionnaire to visually select the best and worst printlet, and 310 participants completed further non-compulsory open questions to elaborate on their choices. Overall, the DLP printlets were the most visually appealing to the children (61.7%) followed by the SLS printlets (21.2%), and with both the FDM (5.4%) and SSE (11.7%) printlets receiving the lowest scores. However, after being informed that the SSE printlets were chewable, the majority of participants changed their selection and favoured this printlet, despite their original choice, in line with children's preference towards chewable dosage forms. Participant age and sex displayed no significant differences in printlet selection. Printlet descriptions were grouped into four distinct categories; appearance, perceived taste, texture and familiarity, and were found to be equally important when creating a quality target product profile for paediatric 3D printed formulations. This study is the first to investigate children's perceptions of printlets, and the findings aim to provide guidance for further development of paediatric-appropriate medicines using different 3DP technologies.
制药领域的3D打印(3DP)是一项颠覆性技术,它能够在配药点制备个性化药物。儿科人群面临着各种药物制剂方面的挑战,如剂量灵活性、患者依从性、掩味以及对吞服片剂的恐惧或困难等,而利用3DP的适应性本质,所有这些因素都有可能被克服。此前已针对成人开展了3D打印制剂的用户可接受性研究;然而,儿童自身的反馈对于确定适合不同年龄段药物的质量目标产品概况至关重要。本研究的目的是调查儿童对不同3D打印片剂(Printlets™)的偏好,这是患者可接受性研究的一项重要前期工作。采用四种不同的3DP技术;数字光处理(DLP)、选择性激光烧结(SLS)、半固体挤出(SSE)和熔融沉积建模(FDM)来制备具有相似物理属性(包括尺寸和形状)的安慰剂Printlets。针对4至11岁的参与者完成了一项单中心、分两部分的调查,以根据对Printlets的视觉检查来确定他们的偏好和意见。共有368名参与者完成了一份个人开放式问卷,通过视觉选择最佳和最差的Printlets,310名参与者完成了进一步的非强制性开放式问题,以详细说明他们的选择。总体而言,DLP Printlets在视觉上对儿童最具吸引力(61.7%),其次是SLS Printlets(21.2%),而FDM(5.4%)和SSE(11.7%)Printlets得分最低。然而,在得知SSE Printlets是可咀嚼的之后,尽管他们最初有选择,但大多数参与者改变了选择,转而青睐这种Printlets,这符合儿童对可咀嚼剂型的偏好。参与者的年龄和性别在Printlets选择上没有显著差异。Printlets的描述分为四个不同类别;外观、感知味道、质地和熟悉度,并且发现在为儿科3D打印制剂创建质量目标产品概况时,这些类别同样重要。本研究首次调查了儿童对Printlets的看法,研究结果旨在为使用不同3DP技术进一步开发适合儿科的药物提供指导。