CRYSTALLINE FORM IV OF TRISODIUM SUPRAMOLECULAR COMPLEX COMPRISING VALSARTAN AND AHU-377 AND METHODS THEREOF

摘要

A novel crystalline Form of trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3- ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3'-methyl-2'-(pentanoyl{2''-(tetrazol-5- ylate)biphenyl-4'-ylmethyl}amino)butyrate] hydrate, process for its preparation, pharmaceutical composition comprising the new form, and use of it for treating or delaying progression or onset of diseases or disorders related to activity of angiotensin receptor 1 (AT1) blockage and neprilysin (NEP) inhibition is disclosed. The novel form was characterized by X-ray powder diffraction, differential scanning calorimetry, and other techniques.