Development and validation of a paediatric oral formulation of clonidine hydrochloride

International Journal of Pharmaceutics
A L de GoedeA Vermes

Abstract

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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Citations

Oct 11, 2017·Pharmaceutical Development and Technology·Arnaud PotierAlain Nicolas
Apr 2, 2014·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Carmen MaMary H H Ensom
Aug 21, 2018·Pharmaceutical Development and Technology·V Merino-BohórquezUNKNOWN Pharmaceutical Technology Working Group and Pediatric Pharmacy Working Group of the Spanish Society of Hospital Pharmacy (SE
Apr 4, 2021·Pharmaceutics·Khadija RouazEncarna García-Montoya
Sep 2, 2021·Journal of Pharmaceutical Health Care and Sciences·Jumpei SaitoAkimasa Yamatani

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