Pamlényi Krisztián, Regdon Géza, Nemes Dániel, Fenyvesi Ferenc, Bácskay Ildikó, Kristó Katalin
Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, H-6720 Szeged, Hungary.
Department of Pharmaceutical Technology, University of Debrecen, H-4032 Debrecen, Hungary.
Pharmaceutics. 2022 Aug 5;14(8):1633. doi: 10.3390/pharmaceutics14081633.
Oral mucoadhesive systems, such as polymer films, are among innovative pharmaceutical products. These systems can be applied in swallowing problems and can also be used in geriatrics and paediatrics. In our earlier work, we successfully formulated buccal mucoadhesive polymer films, which contained cetirizine-hydrochloride (CTZ) as the API. The present study focused on investigating the stability and permeability of the prepared films. The stability of the films was studied with an accelerated stability test. During the stability test, thickness, breaking hardness and in vitro mucoadhesivity were analysed. Furthermore, the interactions were studied with FT-IR spectroscopy, and the changes in the amount of the API were also monitored. Cytotoxicity and cell line permeability studies were carried out on TR 146 buccal cells. Compositions that can preserve more than 85% of the API after 6 months were found. Most of the compositions had a high cell viability of more than 50%. Citric acid (CA) decreased the stability and reduced every physical parameter of the films. However, cell line studies showed that the permeability of the films was enhanced. In our work, we successfully formulated CTZ-containing buccal films with adequate stability, high cell viability and appropriate absorption properties.
口腔粘膜粘附系统，如聚合物薄膜，属于创新型医药产品。这些系统可应用于吞咽问题，也可用于老年医学和儿科学领域。在我们早期的工作中，我们成功制备了含有盐酸西替利嗪（CTZ）作为活性药物成分的口腔粘膜粘附聚合物薄膜。本研究重点在于考察所制备薄膜的稳定性和渗透性。通过加速稳定性试验研究薄膜的稳定性。在稳定性试验期间，分析薄膜的厚度、断裂硬度和体外粘膜粘附性。此外，利用傅里叶变换红外光谱研究相互作用，并监测活性药物成分含量的变化。对TR 146口腔细胞进行细胞毒性和细胞系渗透性研究。发现了在6个月后能保留超过85%活性药物成分的组合物。大多数组合物具有超过50%的高细胞活力。柠檬酸（CA）降低了稳定性并降低了薄膜的各项物理参数。然而，细胞系研究表明薄膜的渗透性增强。在我们的工作中，我们成功制备了具有足够稳定性、高细胞活力和适当吸收特性的含CTZ口腔薄膜。
