Patent ID: 8399501

Claim:
Stable micronized 4′-{2-ethoxy-4-ethyl-5-[((S)-2-mercapto-4-methylpentanoylamino)methyl]imidazol-1-ylmethyl}-3′-fluorobiphenyl-2-carboxylic acid, characterized by a powder x-ray diffraction pattern comprising diffraction peaks at 2Θ values of 6.66±0.20, 9.8±0.20, and 18.12±0.20, where the amount of 4′-{2-ethoxy-4-ethyl-5-[(2-mercapto-4-methylpentanoylamino)methyl]imidazol-1-ylmethyl}-3′-fluorobiphenyl-2-carboxylic acid ethyl ester within the stable micronized acid imidazole does not increase by more than about 0.1% AUC by HPLC relative to the initial amount of acid imidazole, when the stable micronized acid imidazole is maintained at a temperature of about 40° C. for at least 2 weeks.