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Abstract

A non-disintegrating, non-eroding, non-bioadhesive and non-swelling oral controlled release pharmaceutical composition and process for preparation of such compositions is provided which comprises at least one high dose water soluble active ingredient, at least one diluent, at least one binder, and a polymer system comprising of at least one release controlling polymer wherein the composition formulated into a suitable dosage form maintains its geometric shape even after the drug has diffused from the dosage form and provides the concentrations of active ingredient above effective levels for extended periods of time, optionally with other pharmaceutically acceptable excipients. The compositions preferably comprise antibiotic(s) as active ingredient, more preferably Amoxicillin or its pharmaceutically acceptable salts, hydrates, polymorphs, esters, and derivatives thereof, most preferably amoxicillin sodium, either alone or in combination with other antibiotic(s). Also described are controlled release compositions which provide an initial burst release of approximately 20%-40% of the active ingredient within one hour for achieving blood levels equivalent to minimum inhibitory concentration, while maintaining these levels for an extended period of time.

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First Claim