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1. (WO2017129624) FAST DISPERSIBLE PHARMACEUTICAL COMPOSITION COMPRISING TYROSINE-KINASE INHIBITOR
Latest bibliographic data on file with the International Bureau

Pub. No.: WO/2017/129624 International Application No.: PCT/EP2017/051561
Publication Date: 03.08.2017 International Filing Date: 25.01.2017
IPC:
A61K 9/20 (2006.01) ,A61K 31/506 (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
20
Pills, lozenges or tablets
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
495
having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
505
Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
506
not condensed and containing further heterocyclic rings
Applicants:
KRKA, D.D., NOVO MESTO [SI/SI]; Smarjeska cesta 6 8000 Novo Mesto, SI
Inventors:
KORASA, Klemen; SI
KUKEC, Simon; SI
KROSELJ, Vesna; SI
VRECER, Franc; SI
SKRABANJA, Vida; SI
GERMAN ILIC, Tamara; SI
Agent:
ANDRAE | WESTENDORP; Uhlandstr. 2 80336 München, DE
Priority Data:
P-20160002425.01.2016SI
Title (EN) FAST DISPERSIBLE PHARMACEUTICAL COMPOSITION COMPRISING TYROSINE-KINASE INHIBITOR
(FR) COMPOSITION PHARMACEUTIQUE À DISPERSION RAPIDE COMPRENANT UN INHIBITEUR DE LA TYROSINE KINASE
Abstract:
(EN) The present invention relates to a stable pharmaceutical composition in the form of fast dispersible tablets that comprises tyrosine-kinase inhibitor, which is preferably imatinib or a pharmaceutically acceptable salt thereof. The composition is produced by a simple, reliable, straightforward, cost-effective process and by use of standard pharmaceutical excipients. Fast dispersible tablets obtained according to present invention are dispersible in water and/or other aqueous liquids, characterized with disintegration time of less than 3 minutes using purified water at 15-25 °C, preferably at 25°C.
(FR) La présente invention concerne une composition pharmaceutique stable se présentant sous la forme de comprimés à dispersion rapide et comprenant un inhibiteur de la tyrosine kinase, lequel est de préférence de l'imatinib ou un de qualité pharmaceutique de ce dernier. La composition est produite à l'aide d'un procédé simple, fiable, clair et économique, et en utilisant des excipients pharmaceutiques classiques. Les comprimés à dispersion rapide obtenus selon la présente invention sont dispersibles dans l'eau et/ou autres liquides aqueux, et caractérisés par un temps de désintégration inférieur à 3 minutes dans de l'eau purifiée à une température comprise entre 15 et 25 °C, de préférence de 25 °C.
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)
Also published as:
EP3407874EA201891556