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: 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.
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Authors | Pablo Estevez, Oriana Boscolo, Eduardo Quiroga, Rocio Fernandez Penuto, Fabian Buontempo, Valeria Tripodi, Silvia Lucangioli |
Journal | European journal of hospital pharmacy : science and practice
(Eur J Hosp Pharm)
Vol. 23
Issue 4
Pg. 213-218
(Jul 2016)
ISSN: 2047-9964 [Electronic] England |
PMID | 31156851
(Publication Type: Journal Article)
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