Pamlényi Krisztián, Kristó Katalin, Sovány Tamás, Regdon Géza
University of Szeged, Institute of Pharmaceutical Technology and Regulatory Affairs, Eötvös u. 6., H-6720, Szeged, Hungary.
Heliyon. 2022 Aug 23;8(8):e10364. doi: 10.1016/j.heliyon.2022.e10364. eCollection 2022 Aug.
Buccal drug administration is a less explored area, therefore researchers and companies focus on its research because of its innovative potential and opportunities. Buccal polymer films (patches) are considered to be an innovative form and have a great number of advantageous properties. Firstly, patients who suffer from swallowing problems and children can also apply them. The active pharmaceutical ingredient enters the systemic circulation directly without degradation and transformation. The aim of this study was to formulate buccal films with sodium alginate (SA) because it is a rarely used, innovative polymer for the formulation of buccal films. The mechanical, chemical properties and dosage forms of the prepared films were investigated with different methods. To formulate the films, cetirizine dihydrochloride (CTZ) was used as model drug, and glycerol (GLY) was added to make the films more elastic. The samples were prepared and stored at room temperature. As a result, it can be seen that the mechanical properties of all film compositions show good results, especially breaking hardness. The films with high SA concentration containing CTZ had appropriate mucoadhesion forces, so these samples are suitable for application on the buccal mucosa. The results of dissolution confirmed this finding. Finally, it can be said we formulated fast dissolving films and it can be concluded that the films prepared with 3% SA concentration containing 1% and 3% GLY can be recommended for buccal application.
口腔给药是一个较少被探索的领域，因此研究人员和公司因其创新潜力和机会而专注于对其进行研究。口腔聚合物薄膜（贴片）被认为是一种创新形式，具有许多有利特性。首先，患有吞咽问题的患者和儿童也可以使用它们。活性药物成分直接进入体循环，无需降解和转化。本研究的目的是用海藻酸钠（SA）制备口腔薄膜，因为它是一种很少用于制备口腔薄膜的创新聚合物。采用不同方法对制备薄膜的机械性能、化学性质和剂型进行了研究。为了制备薄膜，使用盐酸西替利嗪（CTZ）作为模型药物，并添加甘油（GLY）以使薄膜更具弹性。制备样品并在室温下储存。结果可以看出，所有薄膜组合物的机械性能都显示出良好的结果，尤其是断裂硬度。含有CTZ的高SA浓度薄膜具有适当的粘膜附着力，因此这些样品适合应用于口腔粘膜。溶出结果证实了这一发现。最后，可以说我们制备了速溶薄膜，并且可以得出结论，含有1%和3% GLY的3% SA浓度制备的薄膜可推荐用于口腔给药。
