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1. (WO2013144814) STABLE READY-TO-USE PHARMACEUTICAL COMPOSITION OF PEMETREXED
Latest bibliographic data on file with the International Bureau   

Pub. No.:    WO/2013/144814    International Application No.:    PCT/IB2013/052356
Publication Date: 03.10.2013 International Filing Date: 25.03.2013
IPC:
A61K 9/00 (2006.01), A61K 9/08 (2006.01), A61K 31/519 (2006.01)
Applicants: FRESENIUS KABI ONCOLOGY LTD. [IN/IN]; B - 310, Som Datt Chambers -I Bhikaji Cama Place, New Delhi 110 066 (IN)
Inventors: KHATTAR, Dhiraj; (IN).
KHANNA, Rajesh; (IN).
YADAV, Mukti; (IN).
BURMAN, Krishanu; (IN)
Agent: PRACHI, Tiwari; Fresenius Kabi Oncology Ltd Echelon Industrial Area Plot No. 11, Sector-32 Gurgaon 122 001 Haryana (IN)
Priority Data:
912/DEL/2012 27.03.2012 IN
Title (EN) STABLE READY-TO-USE PHARMACEUTICAL COMPOSITION OF PEMETREXED
(FR) COMPOSITION PHARMACEUTIQUE PRÊTE-À-L'EMPLOI STABLE DE PEMETREXED
Abstract: front page image
(EN)A stable ready-to-use pharmaceutical composition comprising pemetrexed or pharmaceutically acceptable salts thereof, wherein the composition is free from antioxidants, amino acids and chelating agents. Also provided is a process for preparing a stable ready-to-use pharmaceutical composition comprising the steps: i) purging inert gas into a parenterally acceptable aqueous solvent until the dissolved oxygen content of the solvent comes to less than 7 mg/L, preferably less than 3 mg/L; ii) adding pemetrexed disodium under stirring; iii) adjusting the pH of the resulting solution to between 4 to 9; iv) optionally adding additional aqueous solvent; wherein the composition is purged with inert gas throughout the entire process.
(FR)Composition pharmaceutique prête-à-l'emploi et stable comprenant du pemetrexed ou des sels pharmaceutiquement acceptables de celui- ci, dans laquelle la composition est exempte d'antioxydants, d'acides aminés et d'agents chélatants. L'invention concerne également un procédé de préparation d'une composition pharmaceutique prête à l'emploi stable comprenant les étapes consistant à: i) purger un gaz inerte dans un solvant aqueux acceptable par voie parentérale jusqu'à ce que la teneur en oxygène dissous du solvant atteigne une valeur inférieure à 7 mg/L, de préférence inférieure à 3 mg/L; ii) ajouter du disodium de pemetrexed sous agitation; iii) ajuster le pH de la solution résultante à une valeur comprise entre 4 et 9; iv) éventuellement ajouter un supplément de solvant aqueux; la composition étant purgée avec un gaz inerte d'un bout à l'autre du processus.
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, DK, DM, DO, 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, 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, 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, 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, ML, MR, NE, SN, TD, TG).
Publication Language: English (EN)
Filing Language: English (EN)