Development and stability study of glibenclamide oral liquid paediatric formulations for the treatment of permanent neonatal diabetes mellitus. Issue 4 (16th December 2015)

• Record Type: Journal Article
• Authors: Estevez, Pablo; Boscolo, Oriana; Quiroga, Eduardo; Fernandez Penuto, Rocio; Buontempo, Fabian; Tripodi, Valeria; Lucangioli, Silvia
• Is Part Of: European journal of hospital pharmacy. Volume 23:Issue 4(2016)
• Page Start: 213
• Page End: 218
• Publication Date: 2015-12-16
• Subjects: PAEDIATRICS; Pharmacy -- Periodicals; Hospital pharmacies -- Periodicals; 615.1
• DOI: 10.1136/ejhpharm-2015-000763
• Languages: English
• ISSNs: 2047-9956

Abstract

Abstract : Background: Glibenclamide is a second-generation oral sulfonylurea used to treat neonatal permanent diabetes mellitus. It is more effective and safer than the first-generation agents. However, no liquid oral formulation is commercially available and, therefore, it cannot be used for individuals who cannot swallow the solid form. Objectives: To develop and study the physicochemical and microbiological stability of two liquid glibenclamide formulations for the treatment of permanent neonatal diabetes mellitus: two suspensions (2.5 mg/mL)—one using glibenclamide raw material and the other, glibenclamide tablets. Furthermore, high-performance liquid chromatography (HPLC) stability showed that the method is optimised and validated for analysis of glibenclamide in the formulations studied. Methods: Samples were stored at 4°C, 25°C and 40°C. The amount of glibenclamide in each formulation was analysed in duplicate using HPLC at 0, 7, 14, 28, 60 and 90 days. Other parameters were also determined—for example, the appearance, pH and morphology. Microbiological studies according to the guidelines of the US Pharmacopoeia for non-sterile products at 0 and 90 days were carried out. Results: All formulations remained physicochemically and microbiologically stable at three different temperatures during the 90-day study. Therefore, glibenclamide formulations can be stored for at least 90 days at ≤40°C. Conclusions: These formulations are ideally suited for paediatric patients who usually cannot swallow tablets. The proposed analytical method was suitable for studying the stability of different formulations.