Chono Sumio, Matsui Megumi, Nakamura Katsuki, Kasai Ryoya
Division of Pharmaceutics, Hokkaido Pharmaceutical University School of Pharmacy, Hokkaido, Japan.
Keihan Hospital, Osaka, Japan.
J Pharm (Cairo). 2016;2016:6131608. doi: 10.1155/2016/6131608. Epub 2016 Dec 1.
. 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. . 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. . 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. . This study provides useful information for selecting branded or generic lansoprazole OD tablets for individualized treatments.
我们评估了一种品牌（制剂A）和五种通用（制剂B、C、D、E和F）的兰索拉唑口腔崩解片的可接受性和制剂质量。通过对健康受试者进行感官测试来检查可接受性，包括口腔崩解时间、味道、口感和适口性。检查了制剂质量，包括唾液稳定性、耐胃酸能力和肠道溶解行为。制剂F的口腔崩解时间（52秒）明显长于其他制剂（32 - 37秒）。超过90%的受试者对制剂A、E和F没有苦味体验，而50%的受试者对制剂B、C和D有粗糙和粉状的感觉。超过80%的受试者认为制剂A、E和F具有良好的适口性。不同制剂之间的可接受性有所不同。口腔崩解片由含有在胃酸中不稳定的兰索拉唑的肠溶颗粒组成。各制剂的肠溶颗粒在人工唾液和胃液中是稳定的。各制剂在溶解行为上未观察到差异，表明制剂的制剂质量几乎相当。这项研究为选择品牌或通用的兰索拉唑口腔崩解片进行个体化治疗提供了有用信息。
