Patent ID: 6833140
Filing Date: 2004-12-21
Classification: A61K,A61P,C07C,C07D

Abstract:
A method of reducing toxicity of an orally administered therapeutic GABA analog, comprising:formulating the GABA analog as a prodrug comprised of the therapeutic GABA analog covalently bound to a cleavable promoiety; placing the prodrug in a sustained release oral dosage form; introducing the dosage form into the intestinal lumen of a patient by having the patient swallow the dosage form; releasing the prodrug gradually into the intestinal lumen of the patient over a period of hours; and cleaving the promoiety from the prodrug to provide a therapeutic concentration of the GABA analog in the plasma of the patient, wherein the dosage form releases from 0 to 20% of the prodrug in 0 to 2 hours, from 20 to 50% of the prodrug in 2 to 12 hours, from 50 to 85% of the prodrug in 3 to 20 hours and greater than 75% of the prodrug in 5 to 18 hours.