Design of a pediatric oral formulation with a low proportion of hydrochlorothiazide

It is a normal pediatric practice in community and hospital pharmacies to prepare a new drug formulation when no commercial forms of it are available. Any dose or stability control is usually done for these types of compounding formulations due to the effort which means to develop these types of tests in pharmacies. We have studied five different hydrochlorothiazide oral formulations prepared with traditional compounding techniques in pharmacies to treat heart failure and edemas in babies. A Standard Operating Procedure (SOP) was done for every suspension. After the strictly monitoring of the SOP, every suspension was subjected to quality control tests (pH, particle size, viscosity, dose content and stability). There is only one studied formulation that guarantees the correct dose administering and stability after 3 weeks stored at 5 °C and light protected. Both, the percentage of wetting agent and the viscosity of the suspensor vehicle in this formulation make the correct dose administering possible after the formulation is shaken.