Laboratory of Biopharmacy, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan.
AAPS PharmSciTech. 2020 May 17;21(5):135. doi: 10.1208/s12249-020-01686-0.
This study aimed to develop a self-emulsifying drug delivery system (SEDDS) of celecoxib (CEL) for suppressed delay in oral absorption under impaired gastric motility. A pseudo-ternary phase diagram was constructed for the determination of the optimal component ratio in SEDDS of CEL (SEDDS/CEL), and the SEDDS/CEL was physicochemically characterized. A pharmacokinetic study on orally dosed CEL samples (5-mg CEL/kg) was carried out in normal and propantheline (PPT)-treated rats to mimic impaired gastric motility. SEDDS/CEL rapidly formed a fine emulsion with a mean size of 147 nm in distilled water and significantly improved the dissolution behavior of CEL under pH 1.2 condition with a 20-fold higher dissolved amount than crystalline CEL. In normal rats, orally dosed SEDDS/CEL provided a 4.6-fold higher systemic exposure than that of crystalline CEL, due to the improved dissolution properties of CEL. Crystalline CEL showed delayed and decreased oral absorption of CEL in PPT-treated rats as evidenced by a 6.9-h-delayed mean absorption time and only 12% of the systemic exposure of CEL compared with those in normal rats. In contrast, SEDDS/CEL enhanced the oral absorption of CEL with a 14.6-fold higher systemic exposure with significant suppression of delay in absorption than crystalline CEL even in PPT-treated rats. SEDDS/CEL could be an efficacious option for suppressing delay in CEL absorption even under impairment of gastric motility, possibly leading to rapid and reproducible management of severe acute pain.
本研究旨在开发塞来昔布(CEL)的自乳化药物传递系统(SEDDS),以抑制胃动力障碍时口服吸收的延迟。构建了伪三元相图以确定 CEL 的SEDDS(SEDDS/CEL)的最佳组成比,并对 SEDDS/CEL 进行了理化特性表征。在正常和丙胺太林(PPT)处理的大鼠中进行了口服给予 CEL 样品(5mg CEL/kg)的药代动力学研究,以模拟胃动力障碍。SEDDS/CEL 在蒸馏水中迅速形成平均粒径为 147nm 的精细乳液,并显著改善了 CEL 在 pH 1.2 条件下的溶解行为,其溶解量是结晶 CEL 的 20 倍。在正常大鼠中,SEDDS/CEL 口服给药后比结晶 CEL 具有更高的全身暴露量,这是由于 CEL 的溶解性能得到改善。结晶 CEL 在 PPT 处理的大鼠中表现出 CEL 口服吸收的延迟和减少,这表现为平均吸收时间延迟 6.9 小时,且与正常大鼠相比,CEL 的全身暴露量仅为 12%。相比之下,SEDDS/CEL 增强了 CEL 的口服吸收,全身暴露量增加了 14.6 倍,与结晶 CEL 相比,吸收延迟的抑制作用更为显著,即使在 PPT 处理的大鼠中也是如此。SEDDS/CEL 可能是抑制 CEL 吸收延迟的有效选择,即使在胃动力障碍的情况下,也可能实现严重急性疼痛的快速和可重复管理。