AU2014241076A1 — Opioid receptor modulator dosage formulations

USPTO Abstract

Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2, 6-dimethyl-phenyl)-propionyl]- [1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino} -methyl)-2-methoxy-benzoic acid, and processes for the preparation and administration of these formulations. Delivering an active pharmaceutical ingredient ("5-({[2-Amino-3-(4-carbamoyl-2, 6-dimethyl-phenyl)-propionyl] -[1 -(4-phenyl-1 H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid") to a patient requires more than just identifying a molecule and its use. An 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionylH1-(4-phenyl-1H-imidazol-2-yl)-ethyl] -amino}-methyl)-2-methoxy-benzoic acid must be formulated for delivery to a patient and this formulation (in addition to the 5-( {[2-Amino-3-( 4- carbamoyl-2,6-dimethyl-phenyl)-propionyl ]-[ 1-( 4-phenyl-1 H -imidazol-2-yl)-ethyl ]- amino}-methyl) -2-methoxy-benzoic acid activity) is evaluated by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).