학술논문

The absolute bioavailability and the effect of food on a new magnesium lactate dihydrate extended-release caplet in healthy subjects.
Document Type
Article
Source
Drug Development & Industrial Pharmacy. Sep2018, Vol. 44 Issue 9, p1481-1487. 7p.
Subject
Dietary supplements
Magnesium compounds
Pharmacokinetics
Hypomagnesemia
Bioavailability
Language
ISSN
0363-9045
Abstract
Objective: To assess the absolute bioavailability of 20 mEq magnesium lactate extended-release (ER) caplets and to assess the effect of food on the pharmacokinetics of these ER caplets. Significance: Magnesium in different salt forms is available as over-the-counter oral formulations. The absorption and bioavailability is highly affected by the water solubility of the salt form. A new ER caplet of 10 mEq strength of magnesium L-lactate dihydrate has been developed to increase the bioavailability of magnesium. Methods: An open label, single-dose, randomized, three-period, cross-over study in healthy adults was conducted with three treatments: (a) single oral dose of 20 mEq magnesium L-lactate dehydrate under fasting conditions, (b) single intravenous (IV) infusion of 20 mEq magnesium sulfate, and (c) single oral dose of 20 mEq magnesium L-lactate dehydrate under fed conditions. Urine and blood samples were collected for analysis of urinary and serum magnesium concentrations. Results: Absolute bioavailabilities of the caplets under fasted and fed conditions, compared to IV magnesium sulfate, were 20.26% (fasted) and 12.49% (fed) in serum, based on the geometric mean ratio (GMR) of the baseline-adjusted AUC0-72, and 38.11% (fasted) and 40.99% (fed) in urine, based on the GMR of the baseline-adjusted Ae0-72. Relative bioavailability of the caplets comparing the fed and fasted states was 61.67% in serum, based on the GMR of the baseline-adjusted AUC0-72, and 107.57% in urine, based on the GMR of the baseline-adjusted Ae0-72. Conclusions: This new magnesium formulation has reasonable bioavailability and might be a valuable addition to the currently available magnesium oral products. [ABSTRACT FROM AUTHOR]