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1. (WO2014194992) AGOMELATINE FORMULATIONS COMPRISING AGOMELATINE IN THE FORM OF CO-CRYSTALS
Latest bibliographic data on file with the International Bureau   

Pub. No.: WO/2014/194992 International Application No.: PCT/EP2014/001410
Publication Date: 11.12.2014 International Filing Date: 24.05.2014
IPC:
A61K 47/02 (2006.01) ,A61K 47/12 (2006.01) ,A61K 31/165 (2006.01)
Applicants: ZENTIVA, K.S.[CZ/CZ]; U Kabelovny 130 102 37 Praha 10, CZ
Inventors: REZAC, Jaroslav; CZ
PRIBYL, Daniel; CZ
HANOVSKA, Anna; CZ
DAMMER, Ondrej; CZ
Agent: JIROTKOVA, Ivana; Rott, Ruzicka & Guttmann P.O. Box 44 CZ-120 00 Praha 2, CZ
Priority Data:
13002930.906.06.2013EP
Title (EN) AGOMELATINE FORMULATIONS COMPRISING AGOMELATINE IN THE FORM OF CO-CRYSTALS
(FR) FORMULATIONS D'AGOMÉLATINE CONTENANT DE L'AGOMÉLATINE SOUS FORME DE CO-CRISTAUX
Abstract:
(EN) A pharmaceutical formulation of agomelatine for oral use, comprising - agomelatine in the form of agomelatine co-crystals with organic acids and - pharmaceutically acceptable excipients, in which - the agomelatine co-crystals are used in the form of pre-blend of the agomelatine co- crystals with a glidant, - the ratio of the agomelatine co-crystals to the glidant in the pre-blend is lower than or equal to 30 : 1, and - the free-water content in the used pharmaceutically acceptable excipients is lower than or equal to 7% w/w.
(FR) La présente invention concerne une formulation pharmaceutique d'agomélatine à usage oral, comprenant : de l'agomélatine sous la forme de co-cristaux d'agomélatine avec des acides organiques, et des excipients pharmaceutiquement acceptables, les co-cristaux d'agomélatine étant utilisés sous la forme d'un pré-mélange des co-cristaux d'agomélatine avec un agent de coulance, le rapport des co-cristaux d'agomélatine à l'agent de coulance dans le pré-mélange étant inférieur ou égal à 30:1, et la teneur en eau libre dans les excipients pharmaceutiquement acceptables utilisés étant inférieure ou égale à 7 % p/p.
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, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, 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 (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (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)