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1. (WO2018041281) A PHARMACEUTICAL COMPOSITION COMPRISING ROSUVASTATIN AND EZETIMIBE AND A PREPARATION METHOD THEREOF
Latest bibliographic data on file with the International Bureau    Submit observation

Pub. No.:    WO/2018/041281    International Application No.:    PCT/CZ2017/050036
Publication Date: 08.03.2018 International Filing Date: 31.08.2017
IPC:
A61K 9/20 (2006.01), A61K 45/06 (2006.01), A61K 9/24 (2006.01), A61K 31/397 (2006.01), A61K 31/505 (2006.01)
Applicants: ZENTIVA, K.S. [CZ/CZ]; U Kabelovny 130 10237 Praha 10 - Dolni Mecholupy (CZ)
Inventors: PROKOPOVA, Alena; (CZ).
SVOBODOVA, Jaroslava; (CZ).
DAMMER, Ondrej; (CZ).
MIKES, Petr; (CZ)
Agent: HARTVICHOVA, Katerina; (CZ)
Priority Data:
PV 2016-538 05.09.2016 CZ
Title (EN) A PHARMACEUTICAL COMPOSITION COMPRISING ROSUVASTATIN AND EZETIMIBE AND A PREPARATION METHOD THEREOF
(FR) COMPOSITION PHARMACEUTIQUE COMPRENANT DE LA ROSUVASTATINE ET DE L'ÉZÉTIMIBE ET SON PROCÉDÉ DE PRÉPARATION
Abstract: front page image
(EN): The invention relates to a two-layer tablet containing two different active ingredients, namely rosuvastatin of formula I, with the systematic name (3R,5S,6E)-7-[4-(4-fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2--yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid or its pharmaceutically acceptable salts, esters, hydrates or solvates, and ezetimibe of formula II, with the systematic name (3R,4S)-1-(4-fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3--hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one or its pharmaceutically acceptable salts, esters, hydrates or solvates, and suitable pharmaceutically acceptable excipients, in the shape of circular two-layer tablet. The composition has excellent properties both in terms of its physical characteristics and as regards the release rate of the active substances or product stability. (I) (II)
(FR)L'invention concerne un comprimé à deux couches contenant deux principes actifs différents, à savoir de la rosuvastatine de formule I, avec le nom systématique de l’acide (3R,5S,6E)-7-[4-(4-fluorophényl)-2-(N-méthylméthanesulfonamido)-6-(propan-2--yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-énoïque ou ses sels, esters, hydrates ou ses solvates pharmaceutiquement acceptables, et de l'ézétimibe de formule II, avec le nom systématique (3R,4S)-1-(4-fluorophényl)-3-[(3S)-3-(4-fluorophényl)-3--hydroxypropyl]-4-(4-hydroxyphényl)azétidin-2-one ou ses sels, esters, hydrates ou ses solvates pharmaceutiquement acceptables, et des excipients pharmaceutiquement acceptables appropriés, sous la forme d'un comprimé à deux couches circulaire. La composition présente des excellentes propriétés à la fois en termes de caractéristiques physiques et en ce qui concerne le taux de libération des substances actives ou la stabilité du produit. (I) (II)
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)