Abstract: In an oral pharmaceutical controlled release 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 which causes adhesion between the units at elevated temperatures, comprising a water-dispersible film-forming agent, and(2) an outer film layer comprising a water-based film-forming agent which prevents adhesion between the units at elevated temperatures and imparts flowability to the units.The inner film layer may additionally comprise a substance which is capable of forming a continuous phase.By subjecting the thus coated units to heating to accelerate the formation of a continuous phase of the film-forming agent of the inner layer and optionally also of the additional substance, a coating is formed which substantially does not change its diffusion characteristics in the course of time.

Abstract: In an oral pharmaceutical controlled release 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 homogeneous 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.