Patent ID: 8507010

Claim:
A pharmaceutical composition comprising a pharmaceutically acceptable salt of N-{-4-[3-chloro-4-(3-fluoro-benzyloxy)phenylamino]quinazolin-6-yl}-acrylamide as an active ingredient and optionally a pharmaceutically applicable carrier or diluent, and a stabilizer having a dispersing and/or protective effect on the active ingredient, wherein the ratio by weight of the stabilizer to the active ingredient is 1:0.1 to 10, and the stabilizer is one or more selected from the group consisting of hydroxypropyl methyl cellulose, hydroxypropyl cellulose, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxyethyl cellulose, povidone, sodium dodecyl sulphonate, amylum pregelatinisatum, microcrystalline cellulose, polyethylene glycols, dioctyl sulfosuccinate, gelatin, arabic gum, tragacanth, stearic acid, calcium stearate, lecithin, dextran, cholesterol, glycerol monostearate, sorbitan esters, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene stearate, polyvinyl alcohol, poloxamers, colloidal silicon dioxide, magnesium aluminum silicate, alginate, chitosan and polylysine, wherein the active ingredient is crystalline form A, crystalline form B, or crystalline form C of N-{4-[3-chloro-4-(3-fluoro-benzyloxy) phenylamino]quinazolin-6-yl}-acrylamide p-toluene sulfonate, or mixtures thereof, and wherein: high intensity peaks for the crystalline form A in an X-ray powder diffraction measurement are identified at the diffraction angle 2θ(°) with the values 5.92±0.10, 8.64±0.10, 11.86±0.10, 16.58±0.10, 16.94±0.10, 17.86±0.10, 19.12±0.10, 19.66±0.10, 20.12±0.10, 23.42±0.10, 24.14±0.10, 24.80±0.10 and 26.76±0.10; high intensity peaks for the crystalline form B in an X-ray powder diffraction measurement are identified at the diffraction angle 2θ(°) with the values 4.72±0.10, 17.04±0.10, 19.32±0.10 and 24.12±0.10; and high intensity peaks for the crystalline C in an X-ray powder diffraction measurement are identified at the diffraction angle 2θ(°) with the values 3.40±0.10, 6.82±0.10, 7.58±0.10, 11.30±0.10, 14.84±0.10, 15.24±0.10, 17.28±0.10, 17.86±0.10, 18.34±0.10, 20.32±0.10, 22.96±0.10, 23.50±0.10, 24.12±0.10, 24.62±0.10 and 25.86±0.10, with the proviso that when the pharmaceutical composition is prepared, the stabilizer and the active ingredient are firstly homogenously mixed and subsequently mixed with the pharmaceutically applicable carrier or diluents.