Many drugs are unavailable in suitable paediatric dosage forms. We describe the development and validation of a stable paediatric oral formulation of clonidine hydrochloride 50 μg/ml, allowing individualised paediatric dosing and easy administration. Stability of the extemporaneously compounded formulation of clonidine hydrochloride was assessed using a validated HPLC method. Clonidine hydrochloride was stable in the buffered aqueous solution at room temperature for up to 9 months. The described formulation is chemically stable for at least 9 months when stored in brown 100 ml PET bottles at room temperature, enabling adequate oral treatment in paediatric patients.

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International Journal of Pharmaceutics
Department of Pharmacy

de Goede, A.L, Boedhram, R.R, Eckhardt, M, Hanff, L.M, Koch, B.C.P, Vermaat, J.S, & Vermes, A. (2012). Development and validation of a paediatric oral formulation of clonidine hydrochloride. International Journal of Pharmaceutics, 433(1-2), 119–120. doi:10.1016/j.ijpharm.2012.04.055