Desenvolvimento de uma forma farmacêutica líquida de cloridrato de Valganciclovir para pediatria e seu estudo de estabilidade

Abstract

Drugs are a pharmacist product, technically obtained or prepared with prophylactic, curative, palliative or diagnostic purposes. The lack of specific drugs to pediatric patients due to the difficulties of clinical trials of drugs in this population, with the lack of studies of evidencebased medicine, leading to high rates of drug Unlicensed and Off-label use in pediatrics. VALCYTE® tablet contains 450 mg of valganciclovir hydrochloride (GCV), which is an Lvaline ester of ganciclovir (GCV) effective in vitro against herpes virus, but is primarily used against infection with cytomegalovirus (CMV) in pediatrics, inhibiting viral DNA polymerase. The aim of study was to transform a solid dosage form, tablets VGC 450 mg, in a liquid form for pediatric use, assessing their technical and economic feasibility. The following evaluations were performed: compounding suspensions of active to 50 mg/mL in water vehicles, simple syrup and vehicle named GUTE (based in xanthan gum); quality assessment on the rheological behavior (viscosity), the sedimentation rate, pH, density and content of the asset for a period of 160 days. The results demonstrated that the formulations in water and in GUTE showed physical and chemical stability, the same pattern of acid pH; small variations in density and moisture content; pseudo-plastic behavior GUTE for distending and slightly water; rapid sedimentation in water and low in GUTE. It was concluded that it was not possible to compound suspensions GCV in syrup for technical impracticability. However in water and GUTE was possible and practical, stable for 160 days; compounded with technical accuracy and quality, at lower costs and that the GUTE shown to be the best vehicle for adding more technical advantages.