OUATAS TAOUFIK,PROFITLICH THOMAS ALFRED,PATZAK ULRICH,OLTHOFF MARGARETHA,COLLEDGE JEFFREY
申请号：
ARP110101916
公开号：
AR081575A1
申请日:
2011.06.02
申请国别(地区):
AR
年份:
2012
代理人:
摘要：
Pharmaceutical composition for oral administration comprising Bendamustine as active ingredient or an ester, a Salt or a solvate thereof, and a pharmaceutically acceptable excipient, which presents a dissolution of Bendamustine for at least 20 minutes, 60%, 70% and 80% in 40 minutes 60 minutes, measured with a device with Blades at 50 rpm, according to the European PharmacopoeiaIn 500 of a Dissolution Medium At pH 1.5, and pharmaceutically acceptable excipient which is pharmaceutically acceptable non-ionic Surfactant selected from the group consisting of Castor Oil polietoxilado or a derivative thereof and a block copolymer or Ethylene oxide and Propylene Oxide,Or a pharmaceutically acceptable Saccharide selected from the group consisting of one or more Monosaccharides, disaccharides, Oligosaccharides, cyclic Oligosaccharides, polysaccharides and saccharide alcohols, where the ratio between the active ingredient and one or more excipients SAC Arid is within the range of 1: 1 - 5.Use of a Pharmaceutical composition as the former in the oral treatment of a medical condition selected from Chronic Lymphocytic Leukemia, acute Lymphocytic Leukemia, Chronic myelogenous leukemia, acute myelocytic Leukemia, Hodgkin disease, non ho Dgkin, Multiple Myeloma, Breast Cancer, ovarian cancer,Small cell lung cancer and non-small lung cancer cells. Use of a Pharmaceutical composition as the former in a dosing regimen that includes at least a dose of between 100 and 600 mg / m2 of Bendamustine per person on day 1 and Day 2, optionally an I.V. doseOral or between 50 and 150 mg / m2 of a corticosteroid Days 1 to 5, and optionally an appropriate dose of an active Agent selected from the group consisting of a specific Antibody for CD20, a Derivative of anthracycline, a Vinca Alkaloid or a Derivative of Platinum and RePet. This dosage regimen available between 4 and 15 times.After intervals of between two and four weeks.Composición farmacéutica de administración oral que comprende bendam
