CA3254178A1 — Opioid receptor modulator dosage formulations

USPTO Abstract

A solid pharmaceutical formulation containing 5-({[2-amino-3-(4-carbamoyl-2,6-dimethylphenyl)propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino}methyl)-2-methoxybenzoic acid is described, along with methods for preparing and administering such formulations. Administering an active pharmaceutical ingredient (5-({[2-amino-3-(4-carbamoyl-2,6-dimethylphenyl)propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino}methyl)-2-methoxybenzoic acid") to a patient requires more than simply identifying a molecule and its use. A 5-({[2-amino-3-(4-carbamoyl-2,6-dimethylphenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino}methyl)-2-methoxybenzoic acid must be formulated for administration to a patient and this formulation (in addition to the content of 5-({[2-amino-3-(4-carbamoyl-2,6-dimethylphenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino}methyl)-2-methoxybenzoic acid) is evaluated by regulatory bodies such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA).