Crystalline cyclodextrin complexes of ranitidine hydrochloride, process for their preparation and pharmaceutical compositions containing the same
AssigneeHexal Pharma GmbH
InventorsWilfried Fischer, Karin Klokkers
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Abstract
The 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.
Claims10
Complexes of ranitidine hydrochloride as guest substance with .beta.-cyclodextrin host substance.
A pharmaceutical composition comprising as the active ingredient, a complex of ranitidine hydrochloride as the guest substance with .beta.-cyclodextrine as the host substance including a pharmaceutically acceptable carrier.
Process for the production of complexes of ranitidine hydrochloride as guest substance with .beta.-cyclodextrin as host substance, wherein an aqueous solution or suspension of the guest substance and the host substance is formed and the water is removed.
Dependencies are inferred from the claim text.