Physical properties of lansoprazole orally disintegrating tablets
Physical properties of lansoprazole orally disintegrating tablets
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兰索拉唑口腔崩解片的物理性质
DOI：
10.1177/1741134316673226
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
M. Matsui
中科院分区：
文献类型：
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作者：
S. Chono;Katsuki Nakamura;M. Matsui
在这里，我们检查了一种品牌兰索拉唑口腔崩解片和五种仿制药兰索拉唑口腔崩解片（分别为配方 A 和 B、C、D、E 和 F）的物理性质，包括它们的亲水性和片剂强度以及将片剂从包装中压出所需的强度。配方F的润湿时间（38±4秒）约为配方A、B、C、D和E的润湿时间（分别为25±2、14±1、14±1、16±1和22±1秒）的1.5-2.7倍。配方B、C、D、E和F具有硬度（>3 kgf）和脆碎度（<1%），可以承受制造过程和运输过程中的冲击和振动。然而，制剂A不具有足够的片剂强度。配方 C 的包装挤压力 (34.4±3.0N) 约为配方 A、B、D、E 和 F 的 1.2-1.7 倍 (20.1±1.8、29.7±1.3、28.0±1.8、分别为 22.3±±2.3 和 24.2±±2.1N）。这些发现表明，兰索拉唑口腔崩解片的物理性质（例如亲水性、片剂强度和压穿包装推出强度）在不同制剂之间存在差异。这项研究为选择适合每位患者的兰索拉唑口腔崩解片提供了有用的信息。
Here we examined the physical properties of one branded and five generic lansoprazole orally disintegrating tablets (formulations A and B, C, D, E, and F, respectively), including their hydrophilia and tablet strength and the strength required to push the tablets out of a press through package. The wetting time of formulation F (38 ± 4 s) was approximately 1.5–2.7 fold of that of formulations A, B, C, D, and E (25 ± 2, 14 ± 1, 14 ± 1, 16 ± 1, and 22 ± 1 s, respectively). Formulations B, C, D, E, and F had hardness (>3 kgf) and friability (<1%) that could endure impact and vibration of the manufacturing process and transporting. However, formulation A did not have enough tablet strength. The press through package pushing out strength of formulation C (34.4 ± 3.0 N) was approximately 1.2–1.7 fold of that of formulations A, B, D, E, and F (20.1 ± 1.8, 29.7 ± 1.3, 28.0 ± 1.8, 22.3 ± 2.3, and 24.2 ± 2.1 N, respectively). These findings indicate that the physical properties of lansoprazole orally disintegrating tablets, such as their hydrophilia, tablet strength, and press through package pushing out strength, differ between formulations. This study provides useful information for selecting lansoprazole orally disintegrating tablets individually suitable for each patient.