Method of preparing a watersoluble film

A - Human Necessities – 61 – K

Patent

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Details

A61K 47/32 (2006.01) A61K 9/00 (2006.01) A61K 9/70 (2006.01) A61K 31/09 (2006.01) A61K 31/4164 (2006.01) A61K 31/4174 (2006.01) A61K 47/34 (2006.01) A61K 47/38 (2006.01) A61P 15/18 (2006.01) A61P 31/04 (2006.01) A61P 31/10 (2006.01)

Patent

CA 2329556

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.

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