Yoo Okhee, Stanford Demi, von Ungern-Sternberg Britta S, Lim Lee Yong
Division of Pharmacy, School of Allied Health, The University of Western Australia, Perth, WA 6009, Australia.
Institute for Paediatric Perioperative Excellence, The University of Western Australia, Perth, WA 6009, Australia.
Pharmaceutics. 2024 Nov 25;16(12):1513. doi: 10.3390/pharmaceutics16121513.
: Medicine acceptability is crucial for paediatric drug development, yet its assessment remains challenging due to the multifaceted nature of sensory attributes like taste, smell, and mouthfeel. Traditional methods of acceptability evaluation often involve complex questionnaires and lack standardisation, leading to difficulties in a comparative analysis across studies. This study aimed to develop a simplified, standardised approach for assessing medicine acceptability introducing the Net Promoter Score (NPS) framework to derive a Medicine Acceptability Score (MAS). : A retrospective analysis was conducted using taste assessment data from nine paediatric formulations across four studies. The MAS was calculated by identifying an optimal range for categorising participant responses, which encapsulated diverse sensory attributes into a single metric. Validation was performed across various age groups and different formulations to test the reliability and discriminatory power of MAS. : The MAS effectively discriminated between acceptable and unacceptable formulations, providing a practical tool for formulation development. : The MAS offers a novel, standardised metric for evaluating paediatric medicine acceptability, addressing key limitations of traditional methods. Future studies are recommended to refine the MAS model through the establishment of benchmark scores for chronic and acute medications, thereby standardising acceptability assessment of medicines across the pharmaceutical industry.
药物可接受性对于儿科药物研发至关重要，但由于味觉、嗅觉和口感等感官属性具有多面性，其评估仍然具有挑战性。传统的可接受性评估方法通常涉及复杂的问卷且缺乏标准化，导致跨研究进行比较分析存在困难。本研究旨在开发一种简化的、标准化的方法来评估药物可接受性，引入净推荐值（NPS）框架以得出药物可接受性评分（MAS）。：使用来自四项研究中九种儿科制剂的味觉评估数据进行回顾性分析。通过确定用于对参与者反应进行分类的最佳范围来计算MAS，该范围将多种感官属性整合为一个单一指标。在不同年龄组和不同制剂中进行验证，以测试MAS的可靠性和区分能力。：MAS有效地区分了可接受和不可接受的制剂，为制剂开发提供了一种实用工具。：MAS为评估儿科药物可接受性提供了一种新颖的、标准化的指标，解决了传统方法的关键局限性。建议未来的研究通过建立慢性和急性药物的基准评分来完善MAS模型，从而使整个制药行业的药物可接受性评估标准化。
