采用 QbD 方法开发用于类风湿性关节炎治疗的茶树油强化微丸(含姜黄素和双氯芬酸)。

IF 5 3区 化学 Q1 POLYMER SCIENCE Gels Pub Date : 2024-09-30 DOI:10.3390/gels10100634
Shivam Pathak, Ruhi Singh, Afzal Hussain, Nasir Ali Siddiqui, Saurabh Mittal, Annie Gupta
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引用次数: 0

摘要

类风湿性关节炎是一种慢性自身免疫性疾病,每年影响着全球数百万人,如果不及时治疗,有可能造成渐进性关节损伤和使人衰弱的疼痛,因此对患者构成严重威胁。与传统的口服疗法相比,外用抗炎镇痛疗法可缓解局部症状,同时减少全身副作用,因此是治疗类风湿性关节炎的一种很有前景的选择。因此,本研究试图利用茶树油配制一种含有双氯芬酸和姜黄素的微乳凝胶配方,用于类风湿性关节炎的局部用药治疗。表面活性剂和共表面活性剂的比例为 4:1,根据最大乳化区域的伪三元相图进行评估。微乳液采用中央复合可旋转设计(CCRD)进行了优化,并设定了最小粒径、多分散指数和最大透射率等限制条件。Curcufenac-T 微乳液的粒度、多分散指数(PDI)和透射率分别为 151.82 ± 15.9 nm、0.287 ± 0.021 和 -5.78 ± 0.26 mV。DSC 分析证实了制剂中双氯芬酸和姜黄素的稳定性和相容性。加入 1%的 carbopol-934 后,微乳液变成了凝胶状。皮肤渗透分析表明,在 0.5 小时内,Curcufenac-T 微乳和传统凝胶中渗透的双氯芬酸比例分别为 12.1% 和 3.9%,而在 12 小时内,渗透率分别为 82.6% 和 34.2%。体外渗透性表明,与传统凝胶相比,双氯芬酸和姜黄素具有向目标部位有效递送的巨大潜力。因此,可以推断出茶树油集成双氯芬酸和姜黄素微乳凝胶可提高双氯芬酸的疗效,是治疗类风湿性关节炎的理想载体。
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QbD Approach for the Development of Tea Tree Oil-Enhanced Microemulgel Loaded with Curcumin and Diclofenac for Rheumatoid Arthritis Treatment.

Rheumatoid arthritis, a chronic autoimmune disorder affecting millions worldwide each year, poses a significant threat due to its potential for progressive joint damage and debilitating pain if left untreated. Topical anti-inflammatory and analgesic treatments offer localized relief with reduced systemic side effects compared to conventional oral therapies, making them a promising option for managing rheumatoid arthritis. Therefore, the current study endeavored to formulate a microemulsion gel formulation loaded with diclofenac and curcumin for topical administration in the management of rheumatoid arthritis, utilizing Tea tree oil. The ratio of surfactant and cosurfactant was 4:1, assessed by pseudoternary phase diagram on the basis of the maximum emulsification region. The microemulsion underwent optimization using a Central Composite Rotatable Design (CCRD) with constraints of minimum particle size, polydispersity index, and maximum transmittance. The Curcufenac-T microemulsion had a particle size, polydispersity index (PDI), and transmittance of 151.82 ± 15.9 nm, 0.287 ± 0.021, and -5.78 ± 0.26 mV, respectively. DSC analyses confirmed the stability and compatibility of diclofenac and curcumin within the formulation. The microemulsion was changed into gel form by incorporating 1% carbopol-934. Skin permeation analysis revealed that the percentage of diclofenac permeated at 0.5 h from Curcufenac-T microemugel and the conventional gel was 12.1% and 3.9%, respectively, while at 12 h, the rates were 82.6% and 34.2%, respectively. In vitro permeability demonstrated significant potential for the effective delivery of diclofenac and curcumin to targeted sites, compared to conventional gel. Therefore, it was deduced that the Tea tree oil integrated diclofenac and curcumin microemulsion gel could enhance the effectiveness of diclofenac and serve as a promising vehicle for rheumatoid arthritis treatment.

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来源期刊
Gels
Gels POLYMER SCIENCE-
CiteScore
4.70
自引率
19.60%
发文量
707
审稿时长
11 weeks
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