Solid, stable dosage forms with an elastic film coating

Claim 1

A solid, stable dosage form consisting of a core and an elastic film coating on said core, said core comprising at least one medicament and at least one pharmaceutically acceptable excipient, said core being moisture- or temperature- or both moisture- and temperature-sensitive; said elastic film coating being a coating which decomposes in aqueous solution, which coating comprises (a) 20-60% by weight of a water soluble component, (b) 25.5-80% by weight of a water-insoluble, but dispersable component, and (c) 0.54-5% by weight of further pharmaceutically acceptable adjuvants, said water soluble component consisting of hydroxypropyl cellulose having an average molecular weight of 75,000; said water-insoluble, but dispersable component consisting of (I) 5-20% by weight, based upon the total film coating, of an acrylic resin selected from (A) a 70:30 ethyl acrylate/methyl methacrylate copolymer having a molecular weight of 80,000 and (B) a 30:70-70:30 methyl acrylate/methyl methacrylate copolymer having an average molecular weight of 500,000; (II) 20-60% by weight, based on the total film coating, of a pharmaceutically acceptable lubricant; (III) 0.5-5% by weight, based on the total film coating, of a pharmaceutically acceptable wetting agent; and (IV) 0-5% by weight, based on the total film coating, of a pharmaceutically acceptable plasticiser.