纳布美酮漂浮片的处方及评价

Parmeet K Saluja, N. Jain, N. Jain
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摘要

本研究以纳布美酮为模型药物,构建并评价其漂浮片剂。将药药比调整为1:1、1:1.5、1:2,采用湿法制备萘普生钠浮片。用碳酸氢钠和柠檬酸作为生成剂。以异丙醇为溶剂,乳糖为稀释剂,PVP K30为造粒剂。对颗粒剂的配方进行了流动性能评估,对片剂进行了物理特性评估、体外浮力测试和药物含量评估。所有配方显示的数值都在允许范围内,表明生产的片剂质量高。由于产生的气体被限制和保护在聚合物形成的凝胶中,因此注意到药片的密度降低到1以下并出现浮力。随着药药比的增加,F1 ~ F6配方的漂浮滞后时间减小,总漂浮时间增加。以1:1比例配制的制剂的药物释放速率更高,程度更大(即F1, F4和F7)。对所制片剂进行均匀性、硬度、脆性、药物含量、体外浮力实验和溶出度评价。此外,体外释放数据拟合了各种动力学模型。
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Formulation and Evaluation of Floating Tablet of Nabumetone
Nabumetone was used as a model drug in this study to construct and assess floating tablets. By adjusting the drug to polymer ratio to 1:1, 1:1.5, and 1:2, naproxen sodium floating tablets were made utilising the wet granulation method. As generating agents, sodium bicarbonate and citric acid are utilised. With isopropyl alcohol acting as the solvent, lactose is employed as diluents and PVP K30 as a granulating agent. The formulation of the granules was assessed for flow properties, and the tablets were made and assessed for physical characteristics, invitro buoyancy testing, and drug content. All of the formulations displayed values that were within the permitted range, demonstrating the high calibre of the manufactured tablets. A decrease in the density of the tablet below 1 and the emergence of buoyancy were noticed as a result of the gas created being confined and protected within the gel formed by the polymers. As the polymer to drug ratio increases, it was seen that the floating lag time in the formulations F1 to F6 decreased while the total floating duration increased. Drug release from the formulations made in a 1:1 ratio occurred at a higher rate and to a greater extent (i.e. F1, F4, and F7). The produced tablets underwent evaluations for uniformity, hardness, friability, drug content, in vitro buoyancy experiments, and dissolving investigations. In addition, the invitro release data were fitted to various kinetic models.
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