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Effect of a High‐Fat Meal on the Bioavailability of a Polymer‐Coated Erythromycin Particle Tablet Formulation
Author(s) -
Randinitis Edward J.,
Sedman Allen J.,
Welling Peter G.,
Kinkel Arlyn W.
Publication year - 1989
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1989.tb03241.x
Subject(s) - bioavailability , bioequivalence , erythromycin , meal , crossover study , capsule , pharmacokinetics , absorption (acoustics) , dosage form , pharmacology , chemistry , medicine , chromatography , food science , materials science , antibiotics , biochemistry , biology , placebo , botany , alternative medicine , pathology , composite material
The effect of food on the relative bioavailability of an erythromycin particles‐in‐tablet formulation was studied in 27 healthy volunteers, using a four‐way, crossover study design with the following treatments: one or two erythromycin capsules USP (Eryc®, Parke‐Davis), or one polymer‐coated erythromycin particles‐in‐tablet (PCE®, Abbott) administered fasting or with a high‐fat meal. Under fasting conditions the erythromycin particles‐in‐tablet and erythromycin capsule formulations are bioequivalent based on similar t max and dose‐normalized C max and AUC values. The rate and extent of absorption from the particles‐in‐tablet formulation, however, are dramatically reduced following administration with a meal. Mean C max and AUC values decreased by 73% and 72%, respectively, and seven subjects had no detectable erythromycin plasma concentrations for 16 hours following administration of the particles‐in‐tablet formulation with the high‐fat meal. Greater than 40% of the subjects had nonfasting C max and AUC values that were less than 10% of those values following administration of the dose fasting. C max and AUC values in nonfasting subjects were within 75% to 125% of fasting values in only two and one of 27 subjects, respectively. The erythromycin particles‐in‐tablet formulation therefore should not be administered with meals.