METHOD FOR THE PRODUCTION OF FENTANYL-BASED ANESTHETICS FOR THEIR ORAL TRANSMUCOSAL ADMINISTRATION IN A CANDY-LIKE DOSAGE FORM

摘要

A method for the production fentanyl-based analgesics for their oral transmucosal administration in a candy-like dosage form, involving the dissolution of a pharmacologically accepted amount of Fentanyl citrate in purified water and the dissolution of a pharmacologically accepted dye in purified water. Mix polyalcohol sugar with purified water with a ratio polyalcohol/sugar between 17 and 19.5% by weight. Stir slowly over low heat until a liquid and smooth mass is obtained. Add sucrose to this liquid mass with a ratio liquid mass/sucrose between 65% and 67.5% by weight. Heat the mass and bring to a boil from an initial temperature of 128°-1320 C to a maximum temperature of 148°-152° C., until its water content evaporates and the weight of the mass obtained in this step reaches between 88% and 90% by weight with respect to the initial total weight of the liquid mass. Leave the mass to cool to a temperature of about 1280 C, and add the Fentanyl citrate solutions, the dye and flavouring agent, stirring firmly and maintaining the same temperature. Pour this hot mixture with a temperature of about 1300 C into a mould or matrix. Before the candy mass sets, a handle can be attached to each candy piece. When the mould is cold and the candy has solidified, remove from the mould and immediately wrap or bag the pieces.