Bioavailability assessment of a new liquid controlled-release pseudoephedrine product.

Abstract Text

Development of a liquid controlled-release pseudoephedrine product is described. Two bioequivalence studies were conducted. In a single-dose study involving 20 subjects, the bioavailabilities of five controlled-release suspensions with a broad range of drug-release rates were compared with an immediate-release form of pseudoephedrine hydrochloride in a four-way crossover, incomplete block, sequence-randomized study. Serial blood sampling up to 36 hours after drug ingestion provided area-under-the-curve (AUC), maximum plasma concentration (Cmax), and time to peak (tmax). In the multiple-dose study, involving 18 subjects, the bioavailability of the optimal formulation determined from the single-dose study was compared with a reference pseudoephedrine hydrochloride syrup. Serial blood sampling up to 12 hours after drug ingestion was performed to determine AUC, Cmax, and tmax. The single-dose investigation showed that all formulations were bioequivalent except the product with the slowest release rate, which had lower AUC and Cmax values. The results of the multiple-dose study confirmed these findings with the reference syrup. The use of a series of drug formulations with a wide range of release rates permitted selection of an optimal product in addition to providing the information needed to ensure continuous production of bioequivalent products.

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2016-09-01 13:06:26

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Citation:- Graves DA, Rotenberg DA, Woodworth DA, Amsel DA, Hinsvark DA, .Bioavailability assessment of a new liquid controlled-release pseudoephedrine product. Clinical pharmacy -;4()199-203 DOI:



Details of Journal

Journal Title - Clinical pharmacy

ISSN - 0278-2677

Volume - 4

Issue - 2

Publish date - -

Language - eng

Country - UNITED STATES


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