EP1504765A1 — Quickly soluble film preparations

USPTO Abstract

A rapidly soluble film-shaped preparation containing a drug and an edible polymer, wherein the breaking strength of a film thereof is from 200 to 3, 000 g/7 mm, the tensile strength of the film is from 200 to 3, 000 g/15 mm, the water disintegration time Y [sec] is within 300 seconds (Y≤300), and when the reciprocal [mg/mm 2 ] of the specific surface area [mm 2 /mg] of the film is taken as X (X≥0), the relationship of water disintegration time Y [sec]≥7500X 2 is satisfied, and the rapidly soluble film-shaped preparation comprising one drug-containing layer, or having a support layer on one side or both sides of the drug-containing layer, wherein the edible polymer is hydroxypropyl cellulose and/or hydroxypropylmethyl cellulose, the compounding ratio of the drug is from 0.01 to 40% by weight based on the whole preparation, and that of the edible polymer is from 40 to 99.99% by weight based on the whole preparation.