School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.
School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom.
Int J Pharm. 2020 Nov 30;590:119883. doi: 10.1016/j.ijpharm.2020.119883. Epub 2020 Sep 16.
The patient's sensory experience when taking an oral medicine is important in the assessment of its palatability, and acceptability. The aim of this study was to develop tools useful for standardisation of sensory assessment of coated tablets: a lexicon and a sensory wheel. Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets. By adapting the principles used by food sciences, a free-text description of conventional, bitter-tasting or tasteless, coated tablets was performed. In the first assessment, volunteers described the sensory attributes of the first set of tablets. The attributes collected were then validated using a second set of tablets in a separate study with different volunteers. The appropriateness and semantics of each sensory attribute was analysed. Twenty attributes most relevant for assessment of coated tablets were selected for the lexicon and associated with explicit definitions. A collection of all attributes that could possibly be triggered by coated tablets were organised in the form of a sensory wheel. This study provides a valuable insight into the sensory experience while taking a coated tablet and presents tools which can accelerate the development of palatable medicines.
患者口服药物时的感官体验对于评估其口感和可接受性非常重要。本研究旨在开发用于标准化包衣片剂感官评估的工具：词汇表和感官轮。进行了两项随机、双盲感官评估，涉及 83 名和 52 名健康成年志愿者以及两组包衣片剂。通过采用食品科学中使用的原理，对常规、苦口或无味的包衣片剂进行了自由文本描述。在第一次评估中，志愿者描述了第一组片剂的感官属性。然后，使用第二组片剂在另一项具有不同志愿者的单独研究中验证收集到的属性。分析了每个感官属性的适当性和语义。选择了 20 个最适合评估包衣片剂的属性，用于词汇表，并附有明确的定义。将所有可能由包衣片剂引发的属性收集在感官轮中。本研究深入了解了口服包衣片剂时的感官体验，并提供了可以加速开发可口药物的工具。
