Development and validation of a paediatric oral formulation of clonidine hydrochloride

Anna Goede, Ryan Boedhram, Manuel Eckhardt, Lidwien Hanff, Birgit Koch, Chris Vermaat, Andras Vermes

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8 Citations (Scopus)


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 mu g/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. (C) 2012 Elsevier B. V. All rights reserved.
Original languageUndefined/Unknown
Pages (from-to)119-120
Number of pages2
JournalInternational Journal of Pharmaceutics
Issue number1-2
Publication statusPublished - 2012

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