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用于增强活性成分递送的两相凝胶制剂的开发与评价：双氯芬酸钠和樟脑

Development and Evaluation of Two-Phase Gel Formulations for Enhanced Delivery of Active Ingredients: Sodium Diclofenac and Camphor.

作者信息

Kasparaviciene Giedre, Maslii Yuliia, Herbina Nataliia, Kazlauskiene Daiva, Marksa Mindaugas, Bernatoniene Jurga

机构信息

Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, LT-50161 Kaunas, Lithuania.

Department of Industrial Technology of Drugs, National University of Pharmacy, 61002 Kharkiv, Ukraine.

出版信息

Pharmaceutics. 2024 Mar 5;16(3):366. doi: 10.3390/pharmaceutics16030366.

DOI:10.3390/pharmaceutics16030366
PMID:38543261
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10974502/
Abstract

The formulation of biphasic gels as potential semi-solid carriers for hydrophilic and lipophilic active substances is promising for the development of pharmaceutical preparations. The aim of this study was to design a stable bigel composition and to determine the influence of the organogel/hydrogel ratio on the gel's physical-chemical and structural-mechanical properties. The investigated compositions of organogel/hydrogel remained stable at ratios ranging from 5/95 to 40/60. After texture and microstructure analysis, bigels with 20/80 and 25/75 ratios were selected as carriers for the active ingredients, sodium diclofenac and camphor, for use as topical preparations for the treatment of muscle-joint inflammation and pain. Although other researchers have published data on the preparation and evaluation of bigels, there are no scientific results on the development of a two-phase gel with our proposed combination of APIs. Sodium diclofenac release was found to be higher when combined with camphor, which revealed the advantages of the biphasic formulation. The pseudoplastic behavior, thixotropy, and thermal stability of flow of the studied bigel samples was investigated by rheological analysis. Ongoing stability studies confirmed the minimal 6-month period.

摘要

将双相凝胶作为亲水性和亲脂性活性物质的潜在半固体载体进行配方设计，对药物制剂的开发具有重要意义。本研究的目的是设计一种稳定的双凝胶组合物，并确定有机凝胶/水凝胶比例对凝胶物理化学和结构力学性质的影响。所研究的有机凝胶/水凝胶组合物在5/95至40/60的比例范围内保持稳定。经过质地和微观结构分析，选择比例为20/80和25/75的双凝胶作为活性成分双氯芬酸钠和樟脑的载体，用作治疗肌肉关节炎症和疼痛的局部制剂。尽管其他研究人员已经发表了关于双凝胶制备和评价的数据，但对于我们提出的活性药物成分组合开发双相凝胶，尚无科学成果。发现双氯芬酸钠与樟脑联合使用时释放量更高，这揭示了双相制剂的优势。通过流变学分析研究了所研究的双凝胶样品的假塑性行为、触变性和流动热稳定性。正在进行的稳定性研究证实了至少6个月的有效期。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/3442e06aa37b/pharmaceutics-16-00366-g013.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/db624704f6d5/pharmaceutics-16-00366-g009.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/433e45b59612/pharmaceutics-16-00366-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/13b9de4f372c/pharmaceutics-16-00366-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/7bc5ba010a1f/pharmaceutics-16-00366-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/c64465524e45/pharmaceutics-16-00366-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/3ad756939752/pharmaceutics-16-00366-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/46055ed47c05/pharmaceutics-16-00366-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/db624704f6d5/pharmaceutics-16-00366-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/8b28b04454a7/pharmaceutics-16-00366-g010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/bfd5e77f9942/pharmaceutics-16-00366-g011.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/5c6abce1836d/pharmaceutics-16-00366-g012.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991a/10974502/3442e06aa37b/pharmaceutics-16-00366-g013.jpg

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