Department of Pharmacy, College of Medicine and Health Sciences, Wollo University, Ethiopia.
Department of Pharmaceutics, School of Pharmacy, College of Health Sciences, Mekelle University, Ethiopia.
Biomed Res Int. 2021 Oct 14;2021:5571507. doi: 10.1155/2021/5571507. eCollection 2021.
This study is aimed at evaluating the binding effect of gum in granule and tablet formulations using paracetamol as a model drug. Some physicochemical properties of the purified gum such as pH, the presence of tannin and dextrin, solubility, viscosity, loss on drying, total ash value, water solubility index, swelling power, moisture sorption, and powder flow properties were investigated. Paracetamol granules were prepared using wet granulation method at 2%, 4%, 6%, and 8% / of the gum and compared with granules prepared with reference binders (PVP K-30 and Acacia BP) in similar concentrations. The granules were characterized for bulk and tapped densities, compressibility index and Hausner ratio, angle of repose, flow rate, and friability. Finally, the prepared granules were compressed into tablets and evaluated for different tablet characteristics: weight uniformity, thickness, diameter, crushing strength, tensile strength, friability, disintegration time, and release profile. The physicochemical characterization revealed that tannins and dextrin are absent in the gum, and the gum has acidic pH. Both the moisture content and total ash values were within the official limits. Furthermore, the gum was found to be soluble in cold and hot water but insoluble in organic solvent and exhibited a shear thickening viscosity profile and excellent flow properties with excellent compressibility. The granules prepared with the gum of and reference binders showed good particle size distribution and excellent flow and compressibility properties. All the prepared tablets passed pharmacopeial specifications with respect to their uniformity of weight, thickness, and disintegration time. Tablets formulated with gum and acacia BP meet the compendial specification for friability at binder concentrations more than 2%. Drug release properties of all the batches formulated with , PVP, and acacia BP complied with the pharmacopeial specification. It can be concluded that the gum of could be explored as an alternative excipient for its binder effect in granule and tablet formulations.
本研究旨在评估胶在颗粒和片剂制剂中的结合效果,使用扑热息痛作为模型药物。对纯化胶的一些物理化学性质进行了研究,如 pH 值、单宁和糊精的存在、溶解度、粘度、干燥失重、总灰分值、水溶性指数、溶胀能力、水分吸附和粉末流动性能。使用湿法制粒法制备了含有 2%、4%、6%和 8%胶的扑热息痛颗粒,并与以相似浓度制备的参考粘合剂(PVP K-30 和阿拉伯胶 BP)的颗粒进行了比较。对颗粒的堆密度和振实密度、压缩指数和 Hausner 比、休止角、流速和可压性进行了表征。最后,将制备好的颗粒压制成片剂,并对不同的片剂特性进行了评价:重量均匀性、厚度、直径、抗压强度、拉伸强度、脆性、崩解时间和释放曲线。理化特性表明,胶中不存在单宁和糊精,胶呈酸性 pH 值。水分含量和总灰分值均在规定范围内。此外,胶可溶于冷水和热水,但不溶于有机溶剂,具有剪切变稠的粘度特性和优异的流动性能,压缩性良好。含有胶和参考粘合剂的颗粒具有良好的粒径分布和优异的流动和压缩性能。所有制备的片剂在重量、厚度和崩解时间方面均符合药典规格。含有胶和阿拉伯胶的片剂在粘合剂浓度高于 2%时符合脆碎度的药典规格。用胶、PVP 和阿拉伯胶制备的所有批次的药物释放性能均符合药典规定。可以得出结论,胶可作为颗粒和片剂制剂中赋形剂的替代物,具有结合效果。