Masaoka Yasuyuki, Kawasaki Yoichi, Kikuoka Ryo, Ogawa Atsushi, Esumi Satoru, Wada Yudai, Ushio Soichiro, Kitamura Yoshihisa, Sendo Toshiaki
Department of Pharmacy, Okayama University Hospital, 2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558 Japan.
Department of Clinical Pharmacy, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, 2-5-1; Shikata-cho; Kita-ku, Okayama, 700-8558 Japan.
J Pharm Health Care Sci. 2020 Jul 7;6:16. doi: 10.1186/s40780-020-00172-w. eCollection 2020.
Valganciclovir (VGC) is essential for preventing cytomegalovirus infections after transplants in adult and pediatric patients. In pediatric patients, VGC tablets have to be pulverized so that they can be delivered via nasogastric tubes. The "simple suspension method" is usually used to suspend tablets in hot water in Japan. However, the optimal suspension conditions and metering methods for preparing VGC suspensions using the simple suspension method are unclear. The purpose of this study was to clarify these issues.
VGC tablets were suspended in water (initial water temperature: 25 °C or 55 °C) using the simple suspension method. The residual rate of VGC after it had been suspended in hot water was determined using HPLC. In addition, the suspended solution was passed through 6, 8, and 12 Fr. gavage tubes. The VGC concentrations of suspensions produced using different preparation methods were also determined using HPLC.
Cracking the surfaces of VGC tablets and suspending them in water at an initial temperature of 55 °C was effective at dissolving the tablets. The VGC concentration of the suspension remained stable for at least 80 min. Furthermore, the VGC concentration remained stable for 48 h during cold dark storage. Cracking the surfaces of VGC tablets could be a more effective metering method than preparing powder from VGC tablets. In addition, little VGC remained in 6, 8, or 12 Fr. gavage tubes after VGC solution was passed through them.
The amount of VGC should be measured carefully when preparing VGC solutions using the simple suspension method.
缬更昔洛韦（VGC）对于预防成人和儿童患者移植后的巨细胞病毒感染至关重要。在儿科患者中，VGC片剂必须研碎以便通过鼻胃管给药。在日本，通常采用“简单悬浮法”将片剂悬浮于热水中。然而，使用简单悬浮法制备VGC悬浮液的最佳悬浮条件和计量方法尚不清楚。本研究的目的是阐明这些问题。
采用简单悬浮法将VGC片剂悬浮于水中（初始水温：25°C或55°C）。使用高效液相色谱法（HPLC）测定VGC在热水中悬浮后的残留率。此外，将悬浮液通过6Fr、8Fr和12Fr的胃管。还使用HPLC测定了采用不同制备方法产生的悬浮液中VGC的浓度。
将VGC片剂表面弄裂并悬浮于初始温度为55°C的水中能有效溶解片剂。悬浮液中VGC的浓度至少在80分钟内保持稳定。此外，在冷藏黑暗储存期间，VGC浓度在48小时内保持稳定。与从VGC片剂制备粉末相比，弄裂VGC片剂表面可能是一种更有效的计量方法。此外，VGC溶液通过6Fr、8Fr或12Fr的胃管后，胃管中残留的VGC很少。
使用简单悬浮法制备VGC溶液时，应仔细测量VGC的量。
