Diffusion coated multiple-units dosage form

Details Diffusion coated multiple-units dosage form Diffusion coated multiple-units dosage form

A - Human Necessities

61

K

167/153

A61K 9/56 (2006.01) A61K 9/20 (2006.01) A61K 9/50 (2006.01)

Patent

CA 1247009

Diffusion Coated Multiple-Units Dosage Form 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 tempera- tures 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 characteris- tics in the course of time.

474048

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