Stability of Three Different Galenic Liquid Formulations Compounded from Tablet Containing Glibenclamide

Folco,

doi:10.6000/1929-5634.2012.01.02.7

Cited by 2 publications

(2 citation statements)

References 10 publications

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“…Only one study has reported details of glibenclamide oral liquid formulations prepared only from tablets and described their chemical stability over 90 days 14. Our study adds more information, with raw material based formulations and microbiological studies, together with other important characteristics, such as colour, odour, resuspendibility, pH, chemical stability and morphology of suspended particles.…”

Section: Discussionmentioning

confidence: 90%

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

et al. 2015

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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.

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Section: Discussionmentioning

confidence: 90%

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

et al. 2015

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“…Unfortunately, the patient developed severe hypo-DOI: 10.1159/000525989 glycaemia after the first dose. Possible causes could be the use of an extemporaneous solution of this medication with suspected rapid settling, suboptimal tablet dispersion, and inconsistent dose uniformity [22], resulted in dosing inaccuracy. However, there are reports of the effective use of such formulations in neonates with KCNJ11 mutations [23,24].…”

Section: Early Postnatal Glibenclamide Treatmentmentioning

confidence: 99%

Early Postnatal Use of Glibenclamide in Permanent Neonatal Diabetes Secondary to Antenatally Diagnosed <b><i>KJCN11</i></b> Mutation

et al. 2022

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Introduction: Heterozygous activating mutations in KCNJ11 cause both permanent and transient neonatal diabetes. A minority of patients also have neurological features. Early genetic diagnosis has important therapeutic implications as treatment with sulfonylurea provides good metabolic control and exerts a protective effect on neuromuscular function. Case presentation: A term female infant with normal birth weight (2.73 Kg, z-score: -1.69) was admitted to the Neonatal Unit at Addenbrookes Hospital. She had been antenatally diagnosed with KCNJ11 mutation-R201C inherited from her glibenclamide‐treated mother who continued sulfonylurea treatment throughout pregnancy. A continuous glucose monitoring system inserted at 20 hours of age showed progressive rise of blood glucose concentrations, prompting treatment with glibenclamide on day 2 of life. Initial attempts to treat with an extemporaneous solution of glibenclamide (starting dose 0.2mg/kg/day) resulted in inconsistent response and significant hypoglycaemia and hyperglycaemia. A licensed liquid formulation of glibenclamide (Amglidia) at a starting dose of 0.05 mg/kg/day was used with stabilisation of blood glucose profile within 24 hours. Other than a mild transient elevation in transaminase, treatment was well tolerated. At most recent review (age 12 months), the patient remains well with age-appropriate neurodevelopment. Overall glucose control is reasonable with estimated HbA1c of 7.6% (59.9 mmol/mol). Conclusion: Early post-natal glibenclamide treatment of insulin-naïve patients with KATP-dependent neonatal diabetes is safe, provides good metabolic control and has a potential protective effect on neurological function. The formulation of the medicine needs to be carefully considered in the context of the very small doses required in this age group.

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Stability of Three Different Galenic Liquid Formulations Compounded from Tablet Containing Glibenclamide

Cited by 2 publications

References 10 publications

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

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

Early Postnatal Use of Glibenclamide in Permanent Neonatal Diabetes Secondary to Antenatally Diagnosed <b><i>KJCN11</i></b> Mutation

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