| abstract |
A novel modified release pharmaceutical composition is provided wherein the composition comprises at least one antibiotic, preferably amoxicillin or pharmaceutically acceptable salts, esters, polymorphs, isomers, prodrugs, solvates, hydrates, or derivatives thereof, either alone or in combination with another antibiotic as active ingredient, with at least one modifying agent for controlling the release of beta-lactam antibiotics optionally with one or more pharmaceutically acceptable excipients, wherein the dosage form provides the release of not more than about 60% of the antibiotic in about 30 minutes and not less than about 70% of the antibiotic after 8 hours in vitro dissolution studies or when tested in vivo. Further, the compositions of the present invention tested in a group of healthy individuals provide an average peak plasma concentration (Cmax) after at least about 0.5 hours of dosing. The present invention also provides a method for preparing such a dosage form and a method for its use. |