WATER-SOLUBLE OR WATER-DISPERSIBLE (CO)POLYMER OF HYDROXYALKYL (METH)ACRYLATE, METHOD OF PRODUCING THE SAME, AND USE OF THE SAME AS COATING AGENT, BINDER AND/OR FILM-FORMING EXCIPIENT IN PHARMACEUTICAL DOSAGE FORM

摘要

PROBLEM TO BE SOLVED: To obtain a water-soluble or water-dispersible polymer having overcome conventionally unsolved weak points as a coating agent, a binder and/or film-forming excipient in pharmaceutical dosage form, especially for instantly deliverable tablet. SOLUTION: This water-soluble or water-dispersible copolymer is obtained by free-radical polymerization in the presence of a) 80 to 20 wt.% of hydroxy-C1 to C6 alkyl (meth)acrylate and optionally one or more compounds expressed by formula (A) or formula (B) (where R1=H, C1 to C6 alkyl; R2=H, CH3; R3=C1 to C14 alkyl) or mixture thereof, b) 20 to 80 wt.% of polyvinylalcohol(PVA) and c) optionally 0 to 20 wt.% of other polymerizable compound (C). The method of producing the copolymer and the use of the copolymer as a coating agent, a binder and/or film-forming excipient in pharmaceutical dosage form are also provided.