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1. (WO2017148837) DOSAGE FORM COMPOSITIONS COMPRISING AN INHIBITOR OF BRUTON'S TYROSINE KINASE
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Pub. No.: WO/2017/148837 International Application No.: PCT/EP2017/054435
Publication Date: 08.09.2017 International Filing Date: 27.02.2017
IPC:
A61K 31/4985 (2006.01) ,A61K 47/12 (2006.01) ,A61K 9/14 (2006.01) ,A61K 9/20 (2006.01) ,A61P 35/00 (2006.01) ,A61P 37/00 (2006.01)
[IPC code unknown for A61K 31/4985][IPC code unknown for A61K 47/12][IPC code unknown for A61K 9/14][IPC code unknown for A61K 9/20][IPC code unknown for A61P 35][IPC code unknown for A61P 37]
Applicants:
F. HOFFMANN-LA ROCHE AG [CH/CH]; Grenzacherstrasse 124 4070 Basel, CH (AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BE, BF, BG, BH, BJ, BN, BR, BW, BY, BZ, CA, CF, CG, CH, CI, CL, CM, CN, CO, CR, CU, CY, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GD, GE, GH, GM, GN, GQ, GR, GT, GW, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JP, KE, KG, KH, KM, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MC, MD, ME, MG, MK, ML, MN, MR, MT, MW, MX, MY, MZ, NA, NE, NG, NI, NL, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SI, SK, SL, SM, SN, ST, SV, SY, SZ, TD, TG, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, UZ, VC, VN, ZA, ZM, ZW)
GENENTECH, INC. [US/US]; 1 DNA Way South San Francisco, California 94080, US (US)
Inventors:
MAO, Chen; US
KOU, Dawen; US
CHIANG, Po-Chang; US
Agent:
SAUER, Frank; CH
Priority Data:
62/301,37329.02.2016US
Title (EN) DOSAGE FORM COMPOSITIONS COMPRISING AN INHIBITOR OF BRUTON'S TYROSINE KINASE
(FR) COMPOSITIONS DE FORMES GALÉNIQUES COMPRENANT UN INHIBITEUR DE LA TYROSINE KINASE DE BRUTON
Abstract:
(EN) The invention relates generally to pharmaceutical tablet compositions comprising fumaric acid and the compound (S)-2-(3'-(hydroxymethyl)-1-methyl-5-((5-(2-methyl-4- (oxetan-3-yl)piperazin-1-yl)pyridin-2-yl)amino)-6-oxo-1,6-dihydro- [3,4'-bipyridin]-2'-yl)- 7,7-dimethyl-2,3,4,6,7,8-hexahydro-1H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-l-one free base that is an inhibitor of Bruton' s tyrosine kinase. The invention further relates to amorphous solid dispersions comprising at least one polymer and the Bruton' s kinase inhibitor free base compound. The invention further relates to crystalline mesylate salts, crystalline chloride salts and crystalline sulfate salts of the Bruton' s kinase inhibitor free base compound. In some aspects, the crystalline salts are single polymorphs.
(FR) L'invention concerne de façon générale des compositions de comprimés pharmaceutiques comprenant de l'acide fumarique et la base libre du composé (S)-2-(3'-(hydroxyméthyl)-1-méthyl-5-((5-(2-méthyl-4-(oxétane-3-yl)pipérazine-1-yl)pyridine-2-yl)amino)-6-oxo-1,6-dihydro-[3,4'-bipyridine]-2'-yl)-7,7-diméthyl-2,3,4,6,7,8-hexahydro-1H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazine-l-one qui est un inhibiteur de la tyrosine kinase de Bruton. L'invention concerne en outre des dispersions solides amorphes comprenant au moins un polymère et le composé inhibiteur de la kinase de Bruton de type base libre. L'invention concerne en outre des sels mésylates cristallins, des sels de chlorure cristallins et des sels de sulfate cristallins du composé inhibiteur de la kinase de Bruton de type base libre. Dans certains aspects, les sels cristallins sont des polymorphes uniques.
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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, 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 (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, 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)