FIELD: pharmaceutics.
SUBSTANCE: present invention relates to a stable oral pharmaceutical composition of taxoid for administering to mammals, comprising: taxoid selected from paclitaxel or docetaxel or pharmaceutically acceptable salts thereof; solubiliser selected from diethylene glycol monoethyl ether (Transcutol HP) and glycofurol; stabilising agent selected from piperine, graft copolymer of polyvinyl caprolactam - polyvinyl acetate - polyethylene glycol (Soluplus), polyvinylpyrrolidone and hydroxypropyl methylcellulose; surfactant selected from capryl/caproyl macrogol glycerides, alpha-tocopheryl-polyethylene glycol 1000 succinate, polysorbate and PEG hydrogenated castor oil and combinations thereof; solvent selected from propylene glycol and ethyl alcohol and combinations thereof; and oil selected from 1) triglycerides of fatty acids with average chain length, such as fractionated coconut oil, caprylic/capric acid triglycerides, 2) esters of fatty acids and monovalent alkanols, selected from isopropyl myristate, isopropyl palmitate, ethyl linoleate and ethyl oleate, and 3) two esters of fatty acids and propylene glycol, selected from propyleneglycol dicaprylate, propyleneglycol dilaurate; where weight ratio of solubiliser: taxoid and stabilising agent: taxoid varies from 3 to 12.5 and from 0.5 to 3.3 respectively.
EFFECT: invention enables to produce a stable pharmaceutical composition exhibiting improved bioavailability and solubility.
9 cl, 11 ex, 9 tbl, 1 dwg
Authors
Dates
2016-11-27—Published
2011-11-05—Filed