Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children—A Multi-Institutional Collaborative Study

The quality-assured preparation of crushed and diluted preparations for children is a challenge. In this study, multicenter study was conducted to validate the method quality assurance baclofen powder, clonidine hydrocortisone powder prepared from tablets according previously established method. In-hospital were at five medical facilities under different crushing mixing conditions. After storage in closed bottles, in-use laminated paper 120 days, ingredients stability, drug elution, content uniformity after packaging evaluated. All three maintained between 90% 110% their initial days conditions 25 ± 2 °C 60 5% relative humidity, with no change dissolution all formulations made facilities. also acceptable. may contribute pediatric dosage form modification.