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1. (WO2007091109) PHARMACEUTICAL COMPOSITION COMPRISING TACROLIMUS
Latest bibliographic data on file with the International Bureau   

Pub. No.:    WO/2007/091109    International Application No.:    PCT/HU2007/000005
Publication Date: 16.08.2007 International Filing Date: 08.02.2007
IPC:
A61K 9/16 (2006.01), A61K 9/20 (2006.01), A61K 31/436 (2006.01)
Applicants: RICHTER GEDEON VEGYÉSZETI GYÁR RT. [HU/HU]; Gyömröi út 19-21, H-1103 Budapest (HU) (For All Designated States Except US).
KELEN, Ákos [HU/HU]; (HU) (For US Only).
BÁLINT, Sándorné [HU/HU]; (HU) (For US Only).
BÓDIS, Attila [HU/HU]; (HU) (For US Only).
TÓTH, László, Csaba [HU/HU]; (HU) (For US Only)
Inventors: KELEN, Ákos; (HU).
BÁLINT, Sándorné; (HU).
BÓDIS, Attila; (HU).
TÓTH, László, Csaba; (HU)
Common
Representative:
RICHTER GEDEON VEGYÉSZETI GYÁR RT.; Gyömröi út 19-21, H-1103 Budapest (HU)
Priority Data:
P0600097 08.02.2006 HU
Title (EN) PHARMACEUTICAL COMPOSITION COMPRISING TACROLIMUS
(FR) COMPOSITION PHARMACEUTIQUE COMPRENANT DU TACROLIMUS
Abstract: front page image
(EN)The present invention relates to a new pharmaceutical composition comprising tacrolimus in a stable amorphous morphological form with one or more pharmaceutically acceptable excipients characterized that the pharmaceutical composition is not in a solid dispersion form. Furthermore the present invention relates to a process for the preparation of said pharmaceutical composition comprising mixing the diluent and the binder; adding to the resultant mixture the solvent of tacrolimus in ethanol; granulating the resultant mixture; drying the granules; regranulating and homogenizing the granules with the outer phase; optionally adding additional excipients and compressing into tablets or filling into capsules.
(FR)La présente invention concerne une nouvelle composition pharmaceutique qui comprend du tacrolimus sous une forme morphologique amorphe stable avec un ou plusieurs excipients pharmaceutiquement acceptables, caractérisée en ce que la composition pharmaceutique ne se présente pas sous forme de dispersion solide. En outre, la présente invention concerne un procédé de préparation de ladite composition pharmaceutique qui comprend les étapes consistant à mélanger le diluant et le liant, ajouter au mélange résultant le solvant du tacrolimus dans de l'éthanol, granuler le mélange résultant, sécher les granules, regranuler et homogénéiser les granules avec la phase externe, éventuellement ajouter des excipients supplémentaires, et comprimer pour former des comprimés ou remplir dans des capsules.
Designated States: AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MD, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
African Regional Intellectual Property Organization (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, NL, PL, PT, RO, SE, SI, SK, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
Publication Language: English (EN)
Filing Language: English (EN)