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温度对卡拉胶基口腔膜剂生产的影响研究及工艺参数优化

Study of the Effect of Temperature on the Production of Carrageenan-Based Buccal Films and Optimization of the Process Parameters.

作者信息

Kristó Katalin, Sangestani Anahita, Hassan Alharith A A, Rayya Hala, Pamlényi Krisztián, Kelemen András, Csóka Ildikó

机构信息

Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, H-6720 Szeged, Hungary.

Department of Technical Informatics, Faculty of Science and Informatics, University of Szeged, H-6720 Szeged, Hungary.

出版信息

Pharmaceuticals (Basel). 2024 Dec 22;17(12):1737. doi: 10.3390/ph17121737.

Abstract

BACKGROUND/OBJECTIVES: Films in the mouth offer a promising alternative drug delivery system for oral administration, with several advantages over traditional oral formulations. Furthermore, their non-invasive nature and easy administration make them conducive to increasing patient compliance. The use of active agents in these films can further improve their drug delivery properties, making them an even more useful drug delivery system.

METHODS

In this research, carrageenan was used as a polymer, while glycerine was added as a plasticizer, furthermore, lidocaine hydrochloride and diclofenac sodium were used as the active agents. The prepared films were characterized by analytical techniques.

RESULTS

The results showed that glycerine reduced the mucoadhesivity and breaking hardness of the films and increasing the temperature made the films brittle. These results are also confirmed by the statistical analysis. Based on the FTIR results, glycerine can be used in films without structural changes.

CONCLUSIONS

Based on the findings, films prepared from a solution with a concentration of 1.5% carrageenan and 1.5% glycerine at 70 °C are suitable as a drug delivery system for use on the buccal mucosa when combined with active agents. Carrageenan was successfully used as a carrier for two different types of active agents.

摘要

背景/目的:口腔贴膜为口服给药提供了一种有前景的替代药物递送系统,相较于传统口服制剂具有若干优势。此外,其非侵入性和易于给药的特点有助于提高患者的依从性。在这些贴膜中使用活性剂可进一步改善其药物递送性能,使其成为更有用的药物递送系统。

方法

在本研究中,卡拉胶用作聚合物,甘油作为增塑剂添加,此外,盐酸利多卡因和双氯芬酸钠用作活性剂。通过分析技术对制备的贴膜进行表征。

结果

结果表明,甘油降低了贴膜的粘膜粘附性和断裂硬度,温度升高使贴膜变脆。这些结果也得到了统计分析的证实。基于傅里叶变换红外光谱(FTIR)结果,甘油可在不发生结构变化的情况下用于贴膜。

结论

基于这些发现,由浓度为1.5%的卡拉胶和1.5%的甘油在70°C下制成的溶液制备的贴膜,与活性剂结合时适合作为用于颊粘膜的药物递送系统。卡拉胶成功用作两种不同类型活性剂的载体。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bafc/11678058/fe1c200b72b5/pharmaceuticals-17-01737-g001.jpg

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