Empagliflozin: analytical development, identification of degradation product and pharmaceutical derivation for hospital use
Abstract
Diabetes is a set of metabolic disorders and affects more than 400 million individuals worldwide. Type 2 diabetes is characterized by defects in insulin action and secretion, as well as in the regulation of hepatic glucose production. Empagliflozin (EMP) belongs to the gliflozines that are sodium-glucose-2 cotransporter inhibitors, used by oral route to the treatment of type 2 diabetes. The drug was approved by FDA in 2014 and is sold as coated tablets containing 10 and 25 mg (Jardiance®). EMP extemporaneous suspensions (2 mg/mL) using commercial tablets were prepared, using hydroxypropylmethylcellulose (F1) or sodium carboxymethylcellulose (F2) as polymers, to provide an alternative for patients who have difficult in swallowing tablets for hospital use. The formulations were stored at 25 °C and their stability evaluated for 60 days (t60), by the tests of assay, pH, sedimentation volume, particle size, time of redispersion and microbiological control. The EMP quantitation was performed by micellar electrokinetic capillary chromatography that was previously validated. The preparations showed unchanged pH values, which remained around 6.5 over the period; similarly, parameters such as particle size and sedimentation volume showed no difference (p > 0.05) during the study. The results showed no statistical difference (p > 0.05) between F1 and F2 content over 25-days of storage, which were 97.97 ± 1.12% and 99.92 ± 1.20% respectively; both formulations presented microbial levels…
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