Abstract

BackgroundValganciclovir (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.MethodsVGC 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.ResultsCracking 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.ConclusionThe amount of VGC should be measured carefully when preparing VGC solutions using the simple suspension method.

Highlights

  • Valganciclovir (VGC) is essential for preventing cytomegalovirus infections after transplants in adult and pediatric patients

  • In order to evaluate the stability of VGC solutions when they are stored for long periods (1, 24, or 48 h), we examined their stability under the following three experimental conditions: under diffuse light storage (500 lx, 25 °C), dark storage (25 °C), and cold dark storage (4 °C) conditions

  • Examination of the effects of the simple suspension method on VGC tablets When the tablets were suspended at a water temperature of 25 °C and left to rest for 10 min, they remained solid in all groups

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Summary

Introduction

Valganciclovir (VGC) is essential for preventing cytomegalovirus infections after transplants in adult and pediatric patients. VGC tablets have to be pulverized so that they can be delivered via nasogastric tubes. Cytomegalovirus (CMV) infections are a major cause of morbidity and mortality among post-transplant patients [1, 2]. CMV infections are associated with an increased risk of acute graft rejection [3]. Some antiviral drugs can improve graft survival and the outcomes of transplant patients. The antiviral drugs valganciclovir (VGC), acyclovir, valaciclovir, and ganciclovir can be used as prophylaxes against CMV infections. VGC is the gold-standard treatment for preventing and treating CMV infections in adult and pediatric patients [4, 5]. VGC is available in tablet form (450-mg VALIXA® tablets) and as a dry syrup preparation (VALIXA® 5000-mg dry syrup) in Masaoka et al Journal of Pharmaceutical Health Care and Sciences

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