In Vitro Drug-Drug Interaction of Metformin HCl with Omeprazole and Lansoprazole
Abstract
Metformin HCl is an effective oral hypoglycemic agent for glycemic control in diabetes mellitus type 2 patients. Metformin HCl with omeprazole and lansoprazole is often required to control glycemia and cure GERD simultaneously. This raised the probability of drug-drug interactions of metformin HCl with omeprazole and lansoprazole. This study evaluated the in vitro drug-drug interaction between metformin HCl with omeprazole and lansoprazole by applying a dissolution test followed by UPLC analysis. The dissolution test of metformin HCl was conducted both independently and in conjunction with omeprazole and lansoprazole under two gastrointestinal conditions. The study then assessed the quantitative impact of omeprazole and lansoprazole on a single dose of metformin HCl using UPLC analysis. The study results demonstrated that the availability and release percentage of metformin HCl in vitro increased in simulated gastrointestinal conditions when administered with lansoprazole and omeprazole. The dissolution profiles of metformin HCl reference and test batches in the simulated gastrointestinal fluid showed dissimilarity according to the fit factors (f2 and f1). The ANOVA revealed significant results at a 95% CI (P<0.05) when comparing the mean percent release of metformin HCl. This confirms notable differences in the dissolution profiles between the reference and test batches in simulated gastrointestinal fluid. This in vitro metformin HCl, omeprazole, and lansoprazole drug-drug interaction study concluded that metformin HCl in vitro availability increases, which consequently affects bioavailability and could enhance the therapeutic efficacy of metformin HCl. Additional in vivo research is necessary to fully understand the clinical implications of this drug-drug interaction. It is recommended that the co-administration of metformin HCl with omeprazole and lansoprazole be closely monitored, and simultaneous intake of metformin HCl with omeprazole and lansoprazole be avoided.
Keywords: metformin HCl, omeprazole, lansoprazole, UPLC.
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