Patent ID: 6872407

Claim:
A pharmaceutical composition for extended release of clarithromycin in the gastrointestinal tract, to be administered orally, comprising clarithromycin, which, when administered once a day, induces a statistically significantly lower degree of fluctuation value for the clarithromycin concentration in plasma than an equal dosing of the immediate release composition of clarithromycin administered twice a day, while maintaining exposure (AUC 0-24 ) substantially equivalent to the immediate release composition of clarithromycin, wherein the composition further induces a statistically significant lower degree of fluctuation value in plasma than that of the controlled release formulation containing clarithromycin, a water soluble alginate salt, a complex salt of alginic acid, and an organic carboxylic acid, and, which releases clarithromycin so that after a regimen of a single 1000 mg dose on day 1 and a multiple dose regimen of 1000 mg on days 3, 4 and 5, the C max is about 2.45 μg/ml, the C min is about 0.70 μg/ml, the T max is about 8.6 hours, the AUC 0-24 is about 39.6 μg·h/mL, and the fluctuation index is about 1.11.