Moles-Aranda Cristina, Calpena-Campmany Ana C, Halbaut-Bellowa Lyda, Díaz-Tomé Victoria, Otero-Espinar Francisco J, Morales-Molina José A, Clares-Naveros Beatriz
Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Granada, University Campus of Cartuja, 18071 Granada, Spain.
Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, 27-31 Joan XXIII Ave., 08028 Barcelona, Spain.
Pharmaceutics. 2020 Apr 2;12(4):322. doi: 10.3390/pharmaceutics12040322.
Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two techniques used in the resection of gastrointestinal mucosal polyps. The aim of this work is the development and evaluation of an innovative polymeric solution containing sodium carboxymethylcellulose and hyaluronic acid. For this purpose, several mixtures of these two main components, as well as other components such as fructose, citric acid, and zinc, are evaluated in terms of physicochemical and microbiological properties, rheological behavior, extensibility, syringeability, and stability at different storage conditions. Furthermore, the potential production of mucosal elevation and duration is also studied by an ex vivo model using porcine stomach and colon. Results show that the developed polymeric solutions possess optimal values of pH, from 4.58 to 6.63, for their use in the gastrointestinal tract. The formulations exhibit both Newtonian and pseudoplastic behaviors with different viscosity values as a function of their composition. All formulations exhibit high stability properties and no bacterial or fungal growth is detected. MCS01 and MCS05 are the polymeric solutions with the best syringeability results. In this line, MCS05 is the formulation that provides the highest, 2.20 ± 0.18 cm and 1.40 ± 0.11 cm, and longest-lasting, for more than 120 min, elevation effect on porcine submucosal stomach and colon tissues, respectively. Thus, it can be concluded that polymeric solution MCS05 might be considered as a promising tool for use in human EMR and ESD.
内镜黏膜切除术（EMR）和内镜黏膜下剥离术（ESD）是用于切除胃肠道黏膜息肉的两种技术。本研究的目的是开发和评估一种含有羧甲基纤维素钠和透明质酸的创新聚合物溶液。为此，对这两种主要成分的几种混合物以及其他成分（如果糖、柠檬酸和锌）进行了物理化学和微生物学性质、流变行为、延展性、推注性以及在不同储存条件下的稳定性评估。此外，还通过使用猪胃和结肠的离体模型研究了黏膜隆起的可能性和持续时间。结果表明，所开发的聚合物溶液的pH值在4.58至6.63之间，适合在胃肠道中使用。这些制剂表现出牛顿流体和假塑性流体行为，其粘度值随组成而变化。所有制剂均表现出高稳定性，未检测到细菌或真菌生长。MCS01和MCS05是推注性结果最佳的聚合物溶液。在这方面，MCS05制剂对猪胃黏膜下组织和结肠组织分别提供了最高的隆起效果，高度分别为2.20±0.18厘米和1.40±0.11厘米，且持续时间最长，超过120分钟。因此，可以得出结论，聚合物溶液MCS05可能被认为是一种有前途的用于人类EMR和ESD的工具。
