Stability studies of mefenamic acid Self-Nanoemulsifying Drug Delivery System (SNEEDS) preparation with oleic acid as the oil phase

Kartika Jurnal Ilmiah Farmasi Pub Date : 2020-12-05 DOI:10.20885/jif.vol16.iss2.art5

Y. Syukri, Septiani Eka Cahyani, B. Nugroho

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引用次数: 2

Abstract

Background: Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) with low solubility in water. Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) play a role to improve the solubility and bioavailability of mefenamic acid. Objective: This study aimed to determine the stability of mefenamic acid in SNEDDS formulation through various stability studies. Methods: The stability studies conducted consisted of centrifugation test, heating-cooling cycle test, freezethaw cycle test, robustness to dilution, accelerated storage test, and determination of drug content. Results: The centrifugation test, heating-cooling cycle test, and freeze-thaw cycle test showed no phase separation in the samples. The robustness to dilution and accelerated storage test resulted in 2 formulas of mefenamic acid loaded SNEDDS having good stability with 10% oleic acid, 80% tween 80, 10% PEG 400 and 10% oleic acid, 70% tween 80, 20% PEG 400. The determination of drug content in both of these formulations showed 98.20 ± 0.04% and 90.98 ± 0.06%. Conclusion: The SNEDDS formulation of mefenamic acid in this study had good stability. Keywords: SNEDDS, mefenamic acid, stability study, oleic acid

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以油酸为油相制备甲氨甲胺酸自纳米乳化给药系统的稳定性研究

背景:甲氧胺酸是一种水溶性较低的非甾体抗炎药。自纳米乳化给药系统(SNEDDS)在提高甲氧胺酸的溶解度和生物利用度方面发挥着重要作用。目的:通过各种稳定性研究，确定甲氧胺酸在SNEDDS制剂中的稳定性。方法:通过离心试验、冷热循环试验、冻融循环试验、稀释稳健性试验、加速贮存试验、药物含量测定等方法进行稳定性研究。结果:离心试验、冷热循环试验、冻融循环试验均无相分离现象。稀释和加速贮藏试验结果表明，两种甲氧胺酸负载的SNEDDS配方在10%油酸、80%吐温80、10% PEG 400和10%油酸、70%吐温80、20% PEG 400中均具有良好的稳定性。两种制剂的含量测定值分别为98.20±0.04%和90.98±0.06%。结论:本研究中甲氧胺酸的SNEDDS处方具有良好的稳定性。关键词:SNEDDS，甲氧胺酸，稳定性研究，油酸

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Kartika Jurnal Ilmiah Farmasi

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审稿时长

16 weeks