Stability of Three Different Galenic Liquid Formulations Compounded from Tablet Containing Glibenclamide
DOI:
https://doi.org/10.6000/1929-5634.2012.01.02.7Keywords:
Glibenclamide, sulphonylurea, insulin, neonatal diabetes, formulationAbstract
The suspensions of sulfonylurea glyburide (glibenclamide) are compounded extemporaneously for patients suffering from transitional and Permanent Neonatal Diabetes mellitus (PND). The purpose of this study is to compare the stability of three different galenic liquid formulations compounded from tablet containing glibenclamide. The samples were stored at refrigerated (2-8°C) and room temperature and analyzed at different times. All formulations analysed are stable for at least 90 days, but only two guarantee the administration responding to prescription, especially when it comes to giving dosages very small.
References
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[13] Hamdam II, Bani Jaber AK, Abushoffa AM. Development and validation of a stability indicating capillary electophoresis method for the determination of metformin hydrochloride in tablets. J Pharm Biomedical Analysis 2010; 53: 1254-7.
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[15] Bagagiolo S, Moretti V. La stabilità microbiologica dei preparati galenici per uso orale. It J Clinical Pharmacy 2008; 3: 288-9.
[2] Ooi HL, Ling L. Three cases of permanent neonatal diabetes mellitus: genotypes and management outcome. Singapore Med J 2012; 53(7): e142.
[3] Wambacha JA, Marshalla BA, Kosterb JC. Successful sulfonylurea treatment of an insulin-na¨?ve neonate with diabetes mellitus due to a KCNJ11 mutation. Pediatric Diabetes 2010; 11: 286-88.
[4] Edghill EL, Flanagan SE, Ellard S. Permanent neonatal diabetes due to activating mutations in ABCC8 and KCNJ11. Rev Endocr Metab Disord 2010; 11: 193-98.
http://dx.doi.org/10.1007/s11154-010-9149-x
[5] Meena R, Sarah F. Effective Treatment with oral Sulfonylureas in patients with diabetes due to sulfonylurea receptor 1 (SUR1) mutations. Diabetes Care 2008; 31(2).
[6] Isabelle F, Martine V. Neonatal hyperglycaemia and abnormal development of the pancreas. Best Practice Res Clin Endocrinol Metab 2008; 22(1): 17-40.
http://dx.doi.org/10.1016/j.beem.2007.08.003
[7] Masia R, Koster JC, Tumini S. An ATP-Binding Mutation (G334D) in KCNJ11 is associated with a sulfonylurea-insensitive form of developmental delay, epilepsy, and neonatal diabetes. Diabetes 2007; 56.
http://dx.doi.org/10.2337/db06-1275
[8] Ewan RP, Isabelle F. Switching from insulin to oral sulfonylureas in patients with diabetes due to kir6.2 mutations. N Engl J Med 2006; 355: 467-77.
http://dx.doi.org/10.1056/NEJMoa061759
[9] Isabelle F, Philippe F. Neonatal hyperglycaemia and abnormal development of the pancreas. Best Practice Res Clin Endocrinol Metab 2008; 22(1): 17-40.
http://dx.doi.org/10.1016/j.beem.2007.08.003
[10] The Merck Index, 12th ed. Whitehouse Station, NJ, Budavari S 1996.
[11] Yao J, Shi Y-Q, Li Z-R. Development of a RP-HPLC method for screening potentially counterfeit anti-diabetic drugs. J Chromatography B 2007; 853: 254-9.
http://dx.doi.org/10.1016/j.jchromb.2007.03.022
[12] Naraharisetti SB, Kirby BJ, Hebert MF. Validation of a sensitive LC-MS assay for quantification of Glyburide and its metabolite 4-transhydroxy glyburide in plasma and urine: an OPRU Network study. J Chromatography B 2007; 853: 34-41.
http://dx.doi.org/10.1016/j.jchromb.2007.10.010
[13] Hamdam II, Bani Jaber AK, Abushoffa AM. Development and validation of a stability indicating capillary electophoresis method for the determination of metformin hydrochloride in tablets. J Pharm Biomedical Analysis 2010; 53: 1254-7.
http://dx.doi.org/10.1016/j.jpba.2010.03.017
[14] Bansal G, Singh M, Jindal KC. Studies to characterize degradation products in glimepiride. J Pharm Biomedical Analysis 2008; 48: 788-95.
http://dx.doi.org/10.1016/j.jpba.2008.08.003
[15] Bagagiolo S, Moretti V. La stabilità microbiologica dei preparati galenici per uso orale. It J Clinical Pharmacy 2008; 3: 288-9.
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Published
2013-01-04
How to Cite
Di Folco, U., Falco, D. D., Marcucci, F., Nobili, G., Moretti, V., Gioventù, G., & Tubili, C. (2013). Stability of Three Different Galenic Liquid Formulations Compounded from Tablet Containing Glibenclamide. Journal of Nutritional Therapeutics, 1(2), 152–160. https://doi.org/10.6000/1929-5634.2012.01.02.7
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