Crystalline cyclodextrin complexes of ranitidine hydrochloride, process for their preparation and pharmaceutical compositions containing the same

摘要

PCT No. PCT/EP94/00645 Sec. 371 Date Dec. 15, 1995 Sec. 102(e) Date Dec. 15, 1995 PCT Filed Mar. 4, 1994 PCT Pub. No. WO94/20091 PCT Pub. Date Sep. 15, 1994The present invention relates to cyclodextrin inclusion complexes of ranitidine hydrochloride which exhibit a novel, to date unknown crystalline structure, being significantly different from those of known "Form 1 and 2" and to the preparation of such inclusion complexes. The inclusion complexes are prepared from aqueous common solution or suspensions of ranitidine hydrochloride and cyclodextrin by removal of water. As complexing agents alpha -, beta - and gamma-cyclodextrins, their alkylated, hydroxy alkylated derivates or their suitable mixtures are utilized. Finally, the invention concerns pharmaceutical compositions comprising the new complexes.