AMORPHOUS TRISODIUM SACUBITRIL VALSARTAN AND PROCESS FOR ITS PREPARATION

The present invention provides for crystalline Form B1 of N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phenylphenyl-methyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium salt, crystalline Form B2 of N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium...

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Bibliographische Detailangaben
Hauptverfasser: SHANMUGHASAMY, RAJMAHENDRA, CHARYULU, PALLE VENKATA RAGHAVENDRA, VENU, THIRUNELIMADA DEVAIAH, PATEL, PRATIK RAMESHCHANDRA, VIDYASAGAR, REDDY AVATHU
Format: Patent
Sprache:eng
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Zusammenfassung:The present invention provides for crystalline Form B1 of N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phenylphenyl-methyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium salt, crystalline Form B2 of N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium salt, a novel process for the preparation of crystalline Form B of N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phenylphenylmethyl)-4-amino-2R-methyl butanoic acid ethyl ester sodium salt. The present invention also provides for crystalline Form B of (S)-N-(1-Carboxy-2-Methyl-Prop-1-yl)-N-Pentanoyl-N-[2′-(1H-Tetrazol-5-yl)-Biphenyl-4-yl-Methyl]-Amine disodium salt, crystalline Form P of (S)-N-(1-Carboxy-2-Methyl-Prop-1-yl)-N-Pentanoyl-N-[2′-(1H-Tetrazol-5-yl)-Biphenyl-4-yl-Methyl]-Amine disodium salt and processes for their preparation thereof. The present invention further provides an industrial method production of Amorphous Form of Sacubitril valsartan trisodium. The present invention also provides Sfor amorphous solid dispersions of Sacubitril valsartan trisodium with excipients.