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

BackgroundGlibenclamide 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 ca...

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Bibliographic Details
Published in:European journal of hospital pharmacy. Science and practice 2016-07, Vol.23 (4), p.213-218
Main Authors: Estevez, Pablo, Boscolo, Oriana, Quiroga, Eduardo, Fernandez Penuto, Rocio, Buontempo, Fabian, Tripodi, Valeria, Lucangioli, Silvia
Format: Article
Language:English
Subjects:
Acids
Diabetes
Drug dosages
Insulin
Morphology
Mutation
Original
Pediatrics
Pharmaceuticals
Pharmacy
Sodium
Temperature
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Summary:BackgroundGlibenclamide 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.ObjectivesTo 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.MethodsSamples 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.ResultsAll 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.ConclusionsThese 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.
ISSN:2047-9956
2047-9964
DOI:10.1136/ejhpharm-2015-000763