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1. (WO2017111637) PHARMACEUTICAL COMPOSITION COMPRISING DABIGATRAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
Latest bibliographic data on file with the International Bureau

Pub. No.: WO/2017/111637 International Application No.: PCT/PL2016/000156
Publication Date: 29.06.2017 International Filing Date: 23.12.2016
IPC:
A61K 9/48 (2006.01) ,A61K 31/4439 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
48
Preparations in capsules, e.g. of gelatin, of chocolate
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
33
Heterocyclic compounds
395
having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
435
having six-membered rings with one nitrogen as the only ring hetero atom
44
Non-condensed pyridines; Hydrogenated derivatives thereof
4427
containing further heterocyclic ring systems
4439
containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
Applicants:
ZAKLADY FARMACEUTYCZNE POLPHARMA SA [PL/PL]; ul. Pelplinska 19 83-200 Starogard Gdanski, PL
Inventors:
GARBERA, Kamil; PL
CICHOCKI, Marek; PL
SKOCZEN, Przemyslaw; PL
Agent:
OBRYCKI, Pawel; Zaklady Farmaceutyczne Polpharma SA ul. Pelplinska 19 83-200 Starogard Gdanski, PL
Priority Data:
15460137.123.12.2015EP
16460053.808.08.2016EP
Title (EN) PHARMACEUTICAL COMPOSITION COMPRISING DABIGATRAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
(FR) COMPOSITION PHARMACEUTIQUE COMPRENANT DU DABIGATRAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI
Abstract:
(EN) The invention relates to an oral pharmaceutical composition comprising a multi-particulate system comprising dabigatran or a pharmaceutically acceptable salt thereof and an acidic tablet comprising at least one pharmaceutically acceptable organic acid. It also relates to a process for the preparation of the pharmaceutical composition, preferably in the form of capsules and its use in the treatment of venous thromboembolic events and stroke and systemic embolism in adults with non-valvular atrial fibrillation.
(FR) L'invention concerne une composition pharmaceutique à usage oral comprenant un système multiparticulaire comprenant du dabigatran ou un sel pharmaceutiquement acceptable de celui-ci et un comprimé acide comprenant au moins un acide organique pharmaceutiquement acceptable. Un procédé de préparation de la composition pharmaceutique, de préférence sous forme de capsules, et son utilisation dans le traitement d'événements thromboemboliques veineux, de l'AVC et de l'embolie systémique chez l'adulte présentant une fibrillation auriculaire non valvulaire sont en outre décrits.
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 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)