Ingestibility and Formulation Quality of Lansoprazole Orally Disintegrating Tablets.
Ingestibility and Formulation Quality of Lansoprazole Orally Disintegrating Tablets.
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DOI：
10.1155/2016/6131608
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发表时间：
2016
影响因子：
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通讯作者：
Kasai R
中科院分区：
文献类型：
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作者：
Chono S;Matsui M;Nakamura K;Kasai R
目标.我们评价了一种品牌（处方A）和五种通用（处方B、C、D、E和F）兰索拉唑口腔崩解（OD）片的可摄取性和处方质量。方法.在健康受试者中通过感官测试检查了可摄取性，包括口腔崩解时间、味道、口感和适口性。制剂质量，包括唾液稳定性，耐胃酸性，和肠溶出行为，进行了检查。结果和讨论。制剂F的口服崩解时限（52 s）显著长于其他制剂（32-37 s）。超过90%的受试者在使用制剂A、E和F时没有感觉到苦味，而50%的受试者在使用制剂B、C和D时感觉到粗糙和粉状感觉。超过80%的受试者认为制剂A、E和F具有良好的适口性。制剂之间的可摄取性不同。OD片剂由含有兰索拉唑的肠溶颗粒组成，兰索拉唑在胃酸中不稳定。各制剂的肠溶颗粒在人工唾液和胃液中稳定。未观察到制剂之间的溶出行为存在差异，表明制剂的制剂质量几乎相当。结论.本研究为选择品牌或仿制兰索拉唑OD片进行个体化治疗提供了有用信息。
Objectives. We evaluated the ingestibility and formulation quality of one branded (formulation A) and five generic (formulations B, C, D, E, and F) lansoprazole orally disintegrating (OD) tablets. Methods. Ingestibility, including the oral disintegrating time, taste, mouth feeling, and palatability, was examined by sensory testing in healthy subjects. Formulation qualities, including salivary stability, gastric acid resistance, and intestinal dissolution behavior, were examined. Results and Discussion. The oral disintegration time of formulation F (52 s) was significantly longer than that of other formulations (32–37 s). More than 90% of subjects did not experience bitterness with formulations A, E, and F, whereas 50% of subjects felt rough and powdery sensations with formulations B, C, and D. More than 80% of subjects suggested that formulations A, E, and F had good palatability. Ingestibility was different between formulations. OD tablets consist of enteric granules containing lansoprazole, which is unstable in gastric acid. Enteric granules of each formulation were stable in artificial saliva and gastric juice. No differences were observed in dissolution behaviors among the formulations, indicating that the formulation quality of the formulations was almost equivalent. Conclusions. This study provides useful information for selecting branded or generic lansoprazole OD tablets for individualized treatments.