Comparative Bioavailability and Pharmacokinetics Between the Solid Form of Metformin vs a Novel Liquid Extemporaneous Formulation in Children

Metformin pharmacokinetics in a liquid extemporaneous formulation from commercial tablets was determined paediatric patients. A randomized, transversal clinical trial conducted 34 children and adolescents between 7 17 years of age. were randomized to take metformin the and, after 1-week wash period, 500 mg tablet administered them. Blood samples obtained Whatman 903® cards at 0, 1, 2, 4, 8, 12 24 hours. Extraction made by direct precipitation with acetonitrile (ACN) methanol, detection UPLC tandem mass spectrometry. The method accurate, precise, selective linear 50 1000 ng/mL (r = .9982). Comparative pharmacokinetics, vs formulation, as follows: C max 1503.2 1521.4, T 1.5 h 2.3, half-life 8.2 7.5 h. showed similar tablet, ratios (90% CI) geometric mean for 100.63% (89.13–113.6), 98.08% (88.04–109.2), 97.52% (84.9–112.01), , AUC 0-t 0-∞, respectively. Pharmacokinetics using WinNonlin Pro 3.1 software. allowing more precise dose adjustment ease administration.