Importance

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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.

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First Claim