Decreased Bioavailability of Sustained Release Acetazolamide Dosage Forms

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Abstract
Bioequivalence comparisons of two sustained release and an immediate release acetazolamide dosage form performed in normal human volunteers (n = 18) demonstrated a large statistical difference between the preparations. The sustained release dosage forms were 40-70% less available than the rapid release form based on comparisons of AUC data. Plasma level data from subjects given a suspension of acetazolamide yielded a biological half-life of 8.5 (± 2.54) hours which is twice that reported previously. A comparison of the AUC data and dissolution profiles generated for each dosage form showed a rank order correlation when a pH 1.2 dissolution fluid was used; however, correlation was not evident when the dissolution media was exchanged for pH 4.5 or 7.3 dissolution media.

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