Development and stability study of glibenclamide oral liquid paediatric formulations for the treatment N1 of permanent neonatal diabetes mellitus

ESTEVEZ PABLO; BOSCOLO O.; QUIROGA E.; FERNANDEZ PENUTO R.; BUOMTEMPO F.; TRIPODI V.; LUCANGIOLI S.

European Journal of Hospital Pharmacy

European Association of Hospital Pharmacists

Lugar: Bruselas; Año: 2016 vol. 23 p. 213 - 218

Background Glibenclamide is a second-generationoral sulfonylurea used to treat neonatal permanentdiabetes mellitus. It is more effective and safer than thefirst-generation agents. However, no liquid oralformulation is commercially available and, therefore, itcannot be used for individuals who cannot swallow thesolid form.Objectives To develop and study the physicochemicaland microbiological stability of two liquid glibenclamideformulations for the treatment of permanent neonataldiabetes mellitus: two suspensions (2.5 mg/mL)?oneusing glibenclamide raw material and the other,glibenclamide tablets. Furthermore, high-performanceliquid chromatography (HPLC) stability showed that themethod is optimised and validated for analysis ofglibenclamide in the formulations studied.Methods Samples were stored at 4°C, 25°C and 40°C.The amount of glibenclamide in each formulation wasanalysed in duplicate using HPLC at 0, 7, 14, 28, 60and 90 days. Other parameters were also determined?for example, the appearance, pH and morphology.Microbiological studies according to the guidelines of theUS Pharmacopoeia for non-sterile products at 0 and90 days were carried out.Results All formulations remained physicochemicallyand microbiologically stable at three differenttemperatures during the 90-day study. Therefore,glibenclamide formulations can be stored for at least90 days at ≤40°C.Conclusions These formulations are ideally suited forpaediatric patients who usually cannot swallow tablets.The proposed analytical method was suitable forstudying the stability of different formulations.