EP1110546A1 — Method of preparing a water soluble film

USPTO Abstract

The present invention provides a method of preparing a water soluble film. The method comprises (a) preparing a solution comprising a film former, a water soluble plasticizer, a pharmaceutically active agent, and a solvent; (b) drying the solution at a temperature of from about 50 to about 100° C to form a film; and (c) curing the film at a temperature of from about 15 to about 60° C and at a relative humidity of at least about 30%. The film former is a polyacrylic acid, cellulose derivatives, polyethylene oxide, polyvinyl alcohol, or any combination of any of the foregoing. The water soluble plasticizer contains at least one of a hydroxyl, amido, or amino group and has a boiling point greater than about 150° C. The water soluble film of the present invention may be incorporated into vaginal devices, such as tampons and applicators. This method produces a uniform and homogeneous film which is more flexible and drips less than prior water soluble films, especially those incorporated into vaginal dosage forms. As a result, the film is less irritating. Furthermore, unlike most prior art water soluble films, the film may be shaped to provide a larger contact area within a body cavity, such as the vagina, in order to increase drug delivery. The film is also non-messy.