维生素c和蔓越莓提取物泡腾片配方,表征和评价

Haider Ali Gillani, Dr. Maryam Khalid, Sohaid Said, Memona Khalid, Shaista Umbreen, Sonia Tariq
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引用次数: 0

摘要

背景:泡腾片采用口服剂型,可提高患者服药依从性、药物生物利用度和吸收率。蔓越莓(Vaccinium macrocarpon)被广泛用于预防尿路感染,也被建议用于II型糖尿病、肌痛性脑脊髓炎、坏血病,并因其丰富的营养和抗氧化特性而被用作利尿剂。目的:制备蔓越莓维生素c泡腾片并对其进行评价。方法:根据美国食品药品监督管理局(FDA)规定的标准,以柠檬酸和碳酸氢钠配制泡腾片,给药前先溶于水。通过紫外光谱和红外光谱对活性物质和辅料进行了配伍研究,结果表明没有相互作用。配方前研究包括体积密度、抽头密度、休止角、豪斯纳比、卡尔指数和含水量。结果:按美国药典(U.S.P)和英国药典(BP)的规定对制剂的质量变化、厚度、硬度、溶液pH、药物溶出时间、含量均匀度进行评价。稳定性和储存条件研究也进行了监测,药物测定和溶出度的平均结果为96%。结果表明,该制剂具有良好的片剂配方和颗粒流动性能。结论:进一步研究活性药物的靶向性和自发性释放,优化泡腾法可能有助于活性药物的给药,提高患者的依从性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
VITAMIN C AND CRANBERRY EXTRACT EFFERVESCENT TABLET FORMULATION, CHARACTERIZATION, AND EVALUATION
Background: Effervescent floating tablets are used oral dosage form, to enhance the patient compliance, drug bioavailability and to increase the absorption rate. Cranberry (Vaccinium macrocarpon), widely used as a preventive agent against urinary tract infections, also suggested for Type II diabetes, myalgic encephalomyelitis, scurvy, and as a diuretic pill for being rich in nutrients and anti-oxidant properties. Objectives: The aim of the study is to formulate and evaluate the effervescent tablets of Cranberry and Vitamin C. Methodology: As per defined criteria of US FDA, effervescent tablet as per composition is formulated by citric acid and sodium bicarbonate and intended to dissolve in water before administration. Active substance and excipient compatibility studies were done by UV and FTIR, resulted absence of any interaction. Pre-formulation studies including Bulk density, tapped density, angle of repose, Hausner’s ratio, Carr’s index and water content. Results: Formulations were evaluated for weight variation, thickness, hardness, pH of solution, drug dissolution time, content uniformity as defined specification of U.S.P and BP. Stability and storage condition studies were also monitored with average results of 96% drug assay and dissolution. All the results showed excellent formulation of tablet and flow properties of granules. Conclusion: Further studies required to approach targeted and spontaneous release of active as optimized effervescence maybe helpful in delivery of actives and enhancing patient compliance.
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