A quality by design (QbD) approach was used for a polyvinyl alcohol (PVA)-based coating to develop a ‘look-alike’ placebo tablet, which can match the glossiness (shine) of an innovator tablet. Critical coating parameters such as exhaust temperature, drying capacity, solid concentration in coating dispersion, and plasticizer concentration were studied using a full factorial design of experiment (DoE). Total of 20 experimental coating runs was executed on a pilot scale using a perforated pan coater. Coated tablets were evaluated visually against the innovator product by a panel of 13 volunteers using an individual questionnaire about the tablet appearance. The tablet appearance included factors such as tablet surface shine, surface roughness, and logo bridging. These data were analyzed using JMP software. Solid concentration in coating dispersion and drying capacity were found to be the key contributing parameters for tablet surface shine. Human observations were more discerning in spotting subtle differences in tablet appearance than Munsell evaluation. By the judicious selection of a solid concentration in coating dispersion and drying conditions, a look-alike placebo tablet was successfully developed. Change in tablet shape or size did not affect the tablet shine. However, replacement of PVA-based coating with hydroxypropyl methylcellulose (HPMC)-based coating resulted in reduced shine irrespective of tablet shape and size.

设计质量（QbD）方法用于基于聚乙烯醇（PVA）的涂层，以开发出“外观相似”的安慰剂片剂，该片剂可与创新片剂的光泽度（光泽）相匹配。使用全因子设计的实验研究了关键的涂料参数，例如排气温度，干燥能力，涂料分散体中的固体浓度和增塑剂浓度（美国能源部）。使用多孔盘式涂布机以中试规模总共进行了20次实验性涂布。由13名志愿者组成的小组使用关于片剂外观的个人调查问卷，对创新药物产品的涂层片剂进行了视觉评估。平板电脑的外观包括诸如平板电脑表面光泽，表面粗糙度和徽标桥接之类的因素。使用JMP软件分析了这些数据。发现包衣分散体中的固体浓度和干燥能力是片剂表面光泽的关键贡献参数。相比于Munsell评估，人类观察在发现片剂外观的细微差异方面更具辨别力。通过明智地选择包衣分散体和干燥条件下的固体浓度，成功开发了一种外观相似的安慰剂片剂。药片形状或大小的变化不会影响药片的光泽。但是，无论片剂的形状和大小如何，都可以用基于羟丙基甲基纤维素（HPMC）的涂层替代基于PVA的涂层，从而减少光泽。