直接压片辅料LubriTose AN的粉体学评价
Micromeritic evaluation of the direct compression excipient LubriTose AN
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摘要:
本文考察评价了LubriTose AN的粉体学性能, 为其进行直接压片工艺提供初步的理论基础。从流动性、可压性、润滑性及稀释能力等角度考察, 测定了LubriTose AN粉体的休止角、卡氏指数、流出速度、抗张强度、弹性复原率、屈服压力和出片力等指标, 并选择模型药物考察了LubriTose AN的稀释潜能, 评价了其在粉末直接压片工艺中的应用。LubriTose AN的流动性要优于其相应的物理混合物。LubriTose AN和无水乳糖具有相同的形变机制, 主要是脆性形变。在中低压力条件下LubriTose AN的可压性和压实性要优于物理混合物。LubriTose AN对大部分疏水性药物的稀释潜能良好。LubriTose AN具有良好的润滑能力。结果表明, LubriTose AN是一种优良的预混辅料, 对促进和提高片剂的粉末直压工艺有重要意义。
Abstract:This study is to report the evaluation of the micromeritic properties of LubriTose AN, which is expected to provide preliminary theoretical basis for the direct compression technology. From the aspects of flowability, compressibility and dilution potential, the angle of repose, flow velocity, the Carr’ index, tensile strength, elastic recovery, yield pressure and the lubricating ability of LubriTose AN were determined. Also, model drugs were selected to investigate the dilute potential under the desirable compressing performance. Compared to the physical mixtures, the flowability of LubriTose AN was better, and the deformation mechanism was the same with anhydrous lactose, both brittle deformation. The compressibility and compaction of LubriTose AN was slightly better than that of physical mixtures under low and moderate pressure. The dilution potential of LubriTose AN were high for most of hydrophobic drugs. The lubricate ability was desirable under different rotational speeds. LubriTose AN is an excellent co-processed excipient, which is helpful for the promotion and improvement of the tablet manufacturing level.
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