Ciosek-Skibińska Patrycja, Cal Krzysztof, Zakowiecki Daniel, Lenik Joanna
Faculty of Chemistry, Warsaw University of Technology, Noakowskiego 3, 00-664 Warsaw, Poland.
Department of Pharmaceutical Technology, Faculty of Farmacy, Medical University of Gdansk, Al. Gen. J. Hallera 107, 80-416 Gdansk, Poland.
Materials (Basel). 2024 Oct 14;17(20):5016. doi: 10.3390/ma17205016.
Sprinkle formulations represent an interesting genre of medicinal products. A frequent problem, however, is the need to mask the unpleasant taste of these drug substances. In the present work, we propose the use of a novel sensor array based on solid-state ion-selective electrodes to evaluate the taste-masking efficiency of rosuvastatin (ROS) sprinkle formulations. Eight Multiple Unit Pellet Systems (MUPSs) were analyzed at two different doses (API_50) and (API_10), as well as pure Active Pharmaceutical Ingredient (API) as a bitter standard. Calcium phosphate-based starter pellets were coated with the mixture containing rosuvastatin. Some of them were additionally coated with hydroxypropyl methylcellulose, which was intended to separate the bitter substance and prevent it from coming into contact with the taste buds. The sensor array consisted of 16 prepared sensors with a polymer membrane that had a different selectivity towards rosuvastatin calcium. The main analytical parameters (sensitivity, selectivity, response time, pH dependence of potential, drift of potential, lifetime) of the constructed ion-selective electrodes sensitive for rosuvastatin were determined. The signals from the sensors array recorded during the experiments were processed using Principal Component Analysis (PCA). The results obtained, i.e., the chemical images of the pharmaceutical samples, indicated that the electronic tongue composed of the developed solid-state electrodes provided respective attributes as sensor signals, enabling both of various kinds of ROS pellets to be distinguished and their similarity to ROS bitterness standards to be tested.
撒布剂是一类有趣的医药产品。然而，一个常见的问题是需要掩盖这些药物的不良味道。在本研究中，我们提出使用一种基于固态离子选择电极的新型传感器阵列来评估瑞舒伐他汀（ROS）撒布剂的掩味效率。对8种多单元微丸系统（MUPSs）在两种不同剂量（API_50）和（API_10）下进行了分析，同时以纯活性药物成分（API）作为苦味标准物。以磷酸钙为基础的起始微丸用含有瑞舒伐他汀的混合物进行包衣。其中一些还额外用羟丙基甲基纤维素进行包衣，目的是分离苦味物质并防止其与味蕾接触。传感器阵列由16个制备好的传感器组成，其聚合物膜对瑞舒伐他汀钙具有不同的选择性。测定了对瑞舒伐他汀敏感的构建离子选择电极的主要分析参数（灵敏度、选择性、响应时间、电位的pH依赖性、电位漂移、寿命）。实验过程中记录的传感器阵列信号使用主成分分析（PCA）进行处理。所获得的结果，即药物样品的化学图像，表明由开发的固态电极组成的电子舌提供了各自的属性作为传感器信号，既能够区分各种ROS微丸，又能够测试它们与ROS苦味标准物的相似性。
