Why the study?
Does the formulation of betamethasone (tablets vs phosphate solution) affect its pharmacokinetic profile in volunteers?
Does the formulation of betamethasone (tablets vs phosphate solution) affect its pharmacokinetic profile in volunteers?
Betamethasone tablet formulations and phosphate solution have a similar extent of absorption and elimination rates, though the solution is absorbed faster.
Equivalent absorption extent supports interchangeable betamethasone formulations in practice; confirms pharmacokinetic similarity for extent and elimination rates.
Two betamethasone tablet formulations, and betamethasone phosphate solution were compared in a plasma level study. The tablet formulations (A and B) and a solution of betamethasone phosphate (C) were administered in single 2 mg doses to nine volunteers according to a three times repeated Latin square design. Plasma samples were obtained over 72 h following each dose and plasma was analysed for betamethasone by radioimmunoassay. Pharmacokinetic evaluation of the data, obtained according to the one-compartment open model, indicated that there were no significant differences between the extent of absorption, and the first-order elimination rate constants. As would be expected, the solution (C) gave a faster absorption rate than tablets A and B.
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Loo et al. (1981) studied this question.
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