title: Development and validation of a paediatric oral formulation of clonidine hydrochloride.
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.
authors.affiliation: Department of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, The Netherlands. a.l.degoede@erasmusmc.nl
authors.forename: A L
authors.initials: AL
authors.lastname: de Goede
authors.forename: R R
authors.initials: RR
authors.lastname: Boedhram
authors.forename: M
authors.initials: M
authors.lastname: Eckhardt
authors.forename: L M
authors.initials: LM
authors.lastname: Hanff
authors.forename: B C P
authors.initials: BC
authors.lastname: Koch
authors.forename: C H
authors.initials: CH
authors.lastname: Vermaat
authors.forename: A
authors.initials: A
authors.lastname: Vermes
mesh_terms: D000284:Administration, Oral; D058647:Adrenergic alpha-2 Receptor Agonists / Q000008:administration & dosage* / Q000737:chemistry; D002648:Child; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003000:Clonidine / Q000008:administration & dosage* / Q000737:chemistry; D004339:Drug Compounding / Q000379:methods*; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D019999:Pharmaceutical Solutions; D013696:Temperature
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D019999:Pharmaceutical Solutions; D003000:Clonidine