Pharmaceutical composition comprising lapatinib or N-{3-chloro-4-[(3-fluorobenzyl)oxy]phenyl}-6-[5-({[2-(methanesulphonyl)ethyl]amino}methyl)-2-furyl]4-quinazolinamine

摘要

Disclosed is an oral pharmaceutical composition comprising: (i) N-{3-Chloro-4-[(3-fluorobenzyl) oxy]phenyl}-6-[5-({[2-(methanesulphonyl)ethyl] amino}methyl)-2-furyl]-4-quinazolinamine (lapatinib) ditosylate monohydrate in a range of 42 to 48 percent by weight; (ii) povidone in a range of 5.5 to 7.5 percent by weight; (iii) sodium starch glycolate in a range of 3.5 to 5.5 percent by weight; (iv) microcrystalline cellulose in a range of 40 to 46 percent by weight; and (v) magnesium stearate in a range of 0.8 to 1.2 per cent by weight. Also disclosed is an oral pharmaceutical composition comprising: (i) N-{3-Chloro-4-[(3-fluorobenzyl) oxy]phenyl}-6-[5-({[2-(methanesulphonyl)ethyl] amino}methyl)-2-furyl]-4-quinazolinamine (lapatinib) ditosylate monohydrate in a range of 30 to 47 percent by weight; (ii) povidone in a range of 4 to 9 percent by weight; (iii) sodium starch glycolate in a range of 2 to 8 percent by weight; (iv) microcrystalline cellulose in a range of 35 to 50 percent by weight; (v) magnesium stearate in a range of 0.6 to 1.3 percent by weight; and (vi) a film coat in a range of 2.5 to 3.5 percent by weight.