Abstract
A novel method is described that simplifies in vitro dissolution tests of programmerelease drug dosage forms. It is based on a single solid reagent that affords immediate stepped-pH conditions using a single unitization to model the physiological gradient. Six pharmaceutical products were tested using two methods; the paddle method and the through flow cell method. The dissolution efficiencies obtained with the proposed reagent were identical to those obtained with classical buffers used in dissolution tests. Varying dissolution parameters (paddle rotation rate, flow rate in the through flow cell, use of surfactants) gave closely similar results for the two pH stepping methods but with the added advantage of a single medium.
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