Towa Pharmaceutical Co., Ltd, 26-7, Ichiban-Cho, Kadoma, Osaka, 571-0033, Japan.
Department of Pharmaceutical Technology, Kobe Pharmaceutical University, Kobe, Hyogo, 658-8558, Japan.
AAPS PharmSciTech. 2024 Jan 25;25(1):26. doi: 10.1208/s12249-024-02732-x.
The color of the tablets and capsules produced by pharmaceutical companies is important from the perspectives of product branding and counterfeiting. According to some studies, light can change tablet color during storage. In this study, tablets comprising amlodipine besylate (AB), a well-known light-sensitive drug, were coated with commonly used coating materials and exposed to light. Compared to the tablets that were not exposed to light, the color of those exposed to light changed over time. In fact, a faster and more pronounced color change was observed in the tablets exposed to light; however, the amount of AB did not decrease significantly in these tablets. The coating materials and their amounts were varied to clarify the materials involved in the color change. Based on the results, titanium dioxide and hypromellose may be involved in the color change process. As titanium dioxide is a photocatalyst, it may induce or promote chemical changes in hypromellose upon light irradiation. Overall, care should be exercised during selection of the coating polymer because titanium dioxide may promote photodegradation of the coatings while protecting the tablet's active ingredient from light.
制药公司生产的片剂和胶囊的颜色在产品品牌和防伪方面非常重要。根据一些研究,片剂的颜色在储存过程中可能会因光线而发生变化。在这项研究中,对包含苯磺酸氨氯地平(AB)的片剂进行了涂层处理,这是一种众所周知的对光敏感的药物,并将其暴露在光线下。与未暴露在光线下的片剂相比,暴露在光线下的片剂的颜色随时间发生了变化。事实上,暴露在光线下的片剂的颜色变化更快、更明显;然而,这些片剂中 AB 的含量并没有显著减少。改变涂层材料及其用量以阐明参与颜色变化的材料。基于结果,可能涉及二氧化钛和羟丙甲纤维素参与颜色变化过程。由于二氧化钛是一种光催化剂,它可能在光照下诱导或促进羟丙甲纤维素的化学变化。总体而言,在选择涂层聚合物时应谨慎,因为二氧化钛可能会促进涂层的光降解,同时保护片剂的活性成分免受光照。