Method for the production of an orally administered pharmaceutical preparation offering the possibility of controlled release

摘要

In an oral pharmaceutical controlled releasable multiple-units formulation, individual units containing an active substance are coated with a substantially water-insoluble, but water-diffusible controlled release coating which includes 1) an inner film layer comprising a homogenous combination of a water-dispersible film-forming agent and a polymeric substance which imparts compressibility to the coating, and 2) optionally an outer film layer comprising a film-forming agent which prevents adhesion between the units at elevated temperatures and imparts flowability to the units. …The coating possesses a sufficient plastic deformability to result in no significant changes in the release characteristics of compressed coated units relative to non-compressed coated units.