Diffusion coated multiple-units dosage form

A - Human Necessities – 61 – K

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A61K 9/52 (2006.01) A61K 9/20 (2006.01) A61K 9/50 (2006.01) A61K 9/54 (2006.01)

Patent

CA 1248023

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 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 tempera- tures 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.

474047

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