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1. (WO2018078592) AMORPHOUS TRISODIUM SACUBITRIL VALSARTAN AND PROCESS FOR ITS PREPARATION
Latest bibliographic data on file with the International Bureau    Submit observation

Pub. No.:    WO/2018/078592    International Application No.:    PCT/IB2017/056706
Publication Date: 03.05.2018 International Filing Date: 28.10.2017
IPC:
C07C 211/00 (2006.01)
Applicants: BIOCON LIMITED [IN/IN]; 20th KM, Hosur Road, Electronic City, Karnataka Bangalore 560 100 (IN)
Inventors: CHARYULU, Palle Venkata, Raghavendra; (IN).
PATEL, Pratik, Rameshchandra; (IN).
VENU, Thirunelimada Devaiah; (IN).
VIDYASAGAR, Reddy Avathu; (IN).
SHANMUGHASAMY, Rajmahendra; (IN)
Agent: MAJUMDAR, Subhatosh; (IN).
GANGULI, Dr., Sanchita; (IN).
SEN, Abhishek; (IN).
VENKATESH, Mythili; (IN).
MAJUMDAR, Amrita; (IN).
KUNDU, Subarna; (IN).
CHAUBEY, Priyanka; (IN)
Priority Data:
201641037145 28.10.2016 IN
201641038689 11.11.2016 IN
201641043910 22.12.2016 IN
Title (EN) AMORPHOUS TRISODIUM SACUBITRIL VALSARTAN AND PROCESS FOR ITS PREPARATION
(FR) SACUBITRIL/VALSARTAN TRISODIQUE AMORPHE ET SON PROCÉDÉ DE PRÉPARATION
Abstract: front page image
(EN)The present invention provides for crystalline Form B1 of N-(3-carboxyl-1-oxopropyl)- (4S)-(p-phenylphenylmethyl)-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'-(1 H- 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'-(1 H-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 for amorphous solid dispersions of Sacubitril valsartan trisodium with excipients.
(FR)La présente invention concerne la forme cristalline B1 du sel de sodium d'ester éthylique d'acide butanoïque N-(3-carboxyl-1-oxopropyl)-(4S)-(p-phénylphénylméthyl)-4-amino-2 R-méthyl, la forme cristalline B2 du sel de sodium d'ester éthylique d'acide butanoïque N-(3-carboxyl-1-oxopropyl)- (4S)-(p-phénylphénylméthyl)-4-amino -2R-méthyl, un nouveau procédé pour la préparation de la forme cristalline B du sel de sodium d'ester éthylique d'acide butanoïque N-(3-carboxyl-1-oxopropyl)- (4S)-(p-phénylphénylméthyl)-4-amino -2R-méthyl. La présente invention concerne également la forme cristalline B du sel disodique (S)-N-(1-carboxy-2-méthyl-Prop-1-yl)-N-Pentanoyl-N-[2'-(1 H-tétrazol-5-yl)-biphényl-4-yl-méthyl]-amine, la forme cristalline P du sel disodique (S)-N-(1-Carboxy-2-méthyl-Prop-1-yl)-N-Pentanoyl-N- [2'-(1 H-tétrazol-5-yl))-biphényl-4-yl-méthyl]-amine et des procédés pour leur préparation. La présente invention concerne en outre un procédé industriel de production de forme amorphe de sacubitril/valsartan trisodique. La présente invention concerne également des dispersions solides amorphes de sacubitril/valsartan trisodique avec des excipients.
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
African Regional Intellectual Property Organization (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG).
Publication Language: English (EN)
Filing Language: English (EN)