Development and in vitro evaluation of mefenamic acid orodispersible tablets prepared by direct compression.

IF 1.5 4区 生物学 Q4 BIOCHEMISTRY & MOLECULAR BIOLOGY
Muhammad Adnan, Sajid Raza, Muhammad Saad, Azhar Abbas Khan, Muhammad Noman, Marzough Aziz Albalawi, Hayam A Alwabsi, Mohammed Ali Al-Duais, Mohamed Sakran, Reem A K Alharbi, Nermin I Rizk, Ibrahim Jafri, Mohamed M Zayed, Saurabh Pandey, Ayman El Sabagh
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Abstract

Mefenamic acid functions as a nonsteroidal anti-inflammatory drug (NSAID) of the fenamate class, which treats pain and inflammation by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes to decrease prostaglandin production. Mefenamic acid has strong therapeutic properties that help to treat arthritis and dysmenorrhea. The rapid dissolution of orodispersible tablets (ODTs) makes them an effective treatment option for patients with dysphagia. This study developed and evaluated mefenamic acid ODTs through direct compression while adding super-disintegrants, including croscarmellose sodium, crospovidone, and sodium starch glycolate, to improve drug release and disintegration speed. Pre-formulation analysis through FTIR spectroscopy showed that the drug and excipients maintained compatibility without detectable interactions. Product quality assessment included tests for hardness and weight variation, friability and disintegration time, dissolution studies, and stability testing. The performance of the formulation was evaluated through supplementary tests that measured the moisture uptake, wetting time, and water absorption ratio. The zero-order model provided the most accurate explanation of drug release kinetics among the model-dependent approaches, which included the zero-order, first-order, Higuchi, and Hixson-Crowell models. The combination of 7% croscarmellose sodium in formulation F1 produced the best results by enabling quick dissolution while maintaining the optimal disintegration time and improving drug absorption and patient compliance. Stability tests showed that the formulation structure remained consistent during the entire testing period, thus proving its durability. The direct compression method was effective for manufacturing stable mefenamic acid ODTs according to this research. This research demonstrates how super-disintegrants boost formulation performance, establishing ODTs as a promising drug delivery system for better therapeutic results and patient medication compliance.

直接压缩法甲氧胺酸分散片的研制及体外评价。
甲非那酸是一种非甾体类抗炎药(NSAID),通过抑制环氧化酶(COX-1和COX-2)酶来减少前列腺素的产生,从而治疗疼痛和炎症。甲氧胺酸具有很强的治疗特性,有助于治疗关节炎和痛经。口腔分散片(ODTs)的快速溶解使其成为吞咽困难患者的有效治疗选择。本研究通过直接压缩mefenamic acid ODTs,同时添加超崩解剂,包括交联棉糖钠、交联维酮和淀粉乙醇酸钠,来改善药物释放和崩解速度。处方前FTIR光谱分析表明,药物与辅料保持配伍性,无相互作用。产品质量评估包括硬度和重量变化、脆性和崩解时间、溶出度研究和稳定性测试。通过测量吸湿率、润湿时间和吸水率的补充测试来评估配方的性能。在零级、一阶、Higuchi和Hixson-Crowell模型中,零级模型对药物释放动力学的解释最为准确。配方F1中掺入7%交联棉糖钠,既能快速溶出,又能保持最佳崩解时间,提高药物吸收和患者依从性,效果最佳。稳定性试验表明,配方结构在整个试验期间保持一致,证明了其耐久性。根据本研究,直接压缩法是制备稳定的甲氨酰胺酸odt的有效方法。这项研究展示了超级崩解剂如何提高配方性能,将odt作为一种有前途的药物输送系统,以获得更好的治疗效果和患者服药依从性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Cellular and molecular biology
Cellular and molecular biology 生物-生化与分子生物学
CiteScore
1.60
自引率
12.50%
发文量
331
期刊介绍: Cellular and Molecular Biology publishes original articles, reviews, short communications, methods, meta-analysis notes, letters to editor and comments in the interdisciplinary science of Cellular and Molecular Biology linking and integrating molecular biology, biophysics, biochemistry, enzymology, physiology and biotechnology in a dynamic cell and tissue biology environment, applied to human, animals, plants tissues as well to microbial and viral cells. The journal Cellular and Molecular Biology is therefore open to intense interdisciplinary exchanges in medical, dental, veterinary, pharmacological, botanical and biological researches for the demonstration of these multiple links.
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