Preparation, Characterization, and Preclinical Efficacy of In Situ Gels Containing Benzydamine Hydrochloride for Oral Mucositis

IF 3.2 4区医学 Q2 ENGINEERING, BIOMEDICAL

Journal of biomedical materials research. Part B, Applied biomaterials Pub Date : 2025-07-03 DOI:10.1002/jbm.b.35611

Marjan Mehravaran, Azadeh Haeri, Shahram Rabbani, Maryam Torshabi

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Abstract

Oral mucositis occurs after chemo/radiotherapy and can significantly impact patients' quality of life. The objective of this study was to develop and characterize mucoadhesive in situ gels (ISGs) using chitosan (CS) in conjunction with polymers like poloxamer (PLX) and beta-glycerophosphate (βGP) to deliver benzydamine hydrochloride (BNZ) locally. CS/PLX (2.5:20)-BNZ and CS/βGP (2:35)-BNZ were selected based on appropriate gelling temperature/time, appearance, and viscosity. These formulations released 23% and 27% of their drug content during the first 4 h and 30% and 39% during 8 h, respectively. Compared to CS/PLX (2.5:20)-BNZ, CS/βGP (2:35)-BNZ required more force to be injected in the syringeability test and showed less spreadability. G′ related to both ISGs was higher than G″, which indicated an increase in gel consistency and stability at the site of action. The mucoadhesion strength of both ISGs was 10–13 g. FTIR data revealed chemical interactions between polymers but no interaction with BNZ. The antimicrobial effectiveness of ISGs loaded with BNZ was more significant than drug-free ones. In vivo evaluation showed CS/PLX (2.5:20)-BNZ significantly decreased the macroscopic and histopathological features of oral mucositis. In summary, CS/PLX (2.5:20)-BNZ exhibited satisfactory characteristics, suggesting it could be a viable local drug delivery system for oral mucositis.

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盐酸苄胺原位凝胶治疗口腔黏膜炎的制备、表征及临床前疗效

口腔黏膜炎发生在化疗/放疗后，可显著影响患者的生活质量。本研究的目的是利用壳聚糖（CS）与poloxamer （PLX）和β -甘油磷酸酯（βGP）等聚合物结合，开发和表征黏附原位凝胶（ISGs），以局部递送盐酸苄胺（BNZ）。CS/PLX (2.5:20)-BNZ和CS/βGP (2:35)-BNZ是根据合适的胶凝温度/时间、外观和粘度选择的。这些制剂在前4小时和8小时分别释放了23%和27%的药物含量，30%和39%的药物含量。与CS/PLX (2.5:20)-BNZ相比，CS/βGP (2:35)-BNZ在注射性试验中需要更大的力，涂抹性更差。与两种isg相关的G′均高于G″，表明作用部位的凝胶稠度和稳定性增加。两种isg的黏附强度均为10 ~ 13 g。FTIR数据显示聚合物之间存在化学相互作用，但与BNZ没有相互作用。携带BNZ的isg抗菌效果明显优于未携带BNZ的isg。体内评价显示CS/PLX (2.5:20)-BNZ显著降低口腔黏膜炎的宏观和组织病理学特征。综上所述，CS/PLX (2.5:20)-BNZ表现出令人满意的特性，提示其可能是一种可行的口腔黏膜炎局部给药系统。

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来源期刊

Journal of biomedical materials research. Part B, Applied biomaterials 工程技术-材料科学：生物材料

CiteScore

7.50

自引率

2.90%

发文量

199

审稿时长

12 months

期刊介绍： Journal of Biomedical Materials Research – Part B: Applied Biomaterials is a highly interdisciplinary peer-reviewed journal serving the needs of biomaterials professionals who design, develop, produce and apply biomaterials and medical devices. It has the common focus of biomaterials applied to the human body and covers all disciplines where medical devices are used. Papers are published on biomaterials related to medical device development and manufacture, degradation in the body, nano- and biomimetic- biomaterials interactions, mechanics of biomaterials, implant retrieval and analysis, tissue-biomaterial surface interactions, wound healing, infection, drug delivery, standards and regulation of devices, animal and pre-clinical studies of biomaterials and medical devices, and tissue-biopolymer-material combination products. Manuscripts are published in one of six formats: • original research reports • short research and development reports • scientific reviews • current concepts articles • special reports • editorials Journal of Biomedical Materials Research – Part B: Applied Biomaterials is an official journal of the Society for Biomaterials, Japanese Society for Biomaterials, the Australasian Society for Biomaterials, and the Korean Society for Biomaterials. Manuscripts from all countries are invited but must be in English. Authors are not required to be members of the affiliated Societies, but members of these societies are encouraged to submit their work to the journal for consideration.