公开(公告)号：EP1110546A1

公开(公告)日：2001-06-27

申请号：EP00311610.0

申请日：2000-12-22

申请人： Johnson & Johnson Consumer Companies, Inc.

发明人： Lin, Shun Y. ,  Patel, Kalpana J. ,  Link, Martin ,  Kang, Maria L.

IPC分类号： A61K9/70 ,  A61K9/00

CPC分类号： A61K9/7007 ,  A61K9/0034

摘要： 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.

摘要翻译： 本发明提供了制备水溶性薄膜的方法。 该方法包括（a）制备包含成膜剂，水溶性增塑剂，药物活性剂和溶剂的溶液; （b）在约50至约100℃的温度下干燥溶液以形成膜; 和（c）在约15至约60℃的温度和至少约30％的相对湿度下固化该膜。 成膜剂是聚丙烯酸，纤维素衍生物，聚环氧乙烷，聚乙烯醇，或任何上述物质的组合。 水溶性增塑剂含有羟基，酰胺基或氨基中的至少一种，并且具有大于约150℃的沸点。本发明的水溶性薄膜可以并入阴道装置如棉塞和涂抹器中。 该方法产生均匀且均匀的膜，其比现有的水溶性薄膜，特别是并入阴道剂型更为柔软并且滴下。 因此，这部电影不那么刺激。 此外，与大多数现有技术的水溶性膜不同，膜可以被成形为在体腔（例如阴道）内提供更大的接触面积，以增加药物递送。 这部电影也是不乱的。