PHARMACEUTICAL COMPOSITION COMPRISING ERLOTINIB HYDROCHLORIDE

摘要

The present invention relates to a pharmaceutical composition comprising granules comprising erlotinib hydrochloride polymorph A and a water soluble binder selected from sodium carboxymethylcellulose and xanthan gum, exhibiting an in vitro release profile wherein on average from 10 to 30% of the erlotinib hydrochloride is dissolved within 15 minutes, from 20 to 40% within 30 minutes and from 30 to 60% within 60 minutes after placement of the composition in a dissolution test conducted using USP apparatus II at 75 rpm and a dissolution medium of 0.1 N HCl, pH 1.0 at 37ºC. The invention further relates to the use of said compositions as a medicament, particularly in the treatment of non-small cell lung cancer and pancreatic cancer.