VAGINAL SUPPOSITORY OF ARASERTACONAZOLE MONONITRATE, METHOD FOR ITS MANUFACTURE AND METHOD FOR TREATING VULVOVAGINAL CANDIDIOSIS WITH ITS HELP

摘要

1. Vaginal suppository containing arasertaconazole mononitrate in an amount of 100 to 1000 mg and a mixture of excipients, which includes ingredients in the following ratio, of the total weight of the suppository, wt.%:! colloidal silicon dioxide 0.5 ÷ 5 fat base else! 2. The suppository according to claim 1, in which the amount of arasertaconazole mononitrate is 3 ÷ 50 wt.%. ! 3. The suppository according to claim 1, in which the amount of arasertaconazole mononitrate is from 150 to 600 mg. ! 4. The suppository according to claim 3, in which the amount of arasertaconazole mononitrate is 5 ÷ 30 wt.%. ! 5. The suppository according to claim 1, in which the amount of colloidal silicon dioxide is 3 wt.%. ! 6. The suppository according to claim 1, in which colloidal silicon dioxide is anhydrous. ! 7. The suppository according to claim 1, in which the fat base is selected from the group comprising triglyceride, monoglyceride and diglyceride esters of C8-C20 fatty acids and mixtures thereof. ! 8. A method of manufacturing a suppository according to claim 1, comprising melting the fat base at a temperature of 35 ÷ 80 ° C, adding colloidal silicon dioxide to the molten fat base with stirring, pre-cooling the resulting mixture by slow mixing to reach a temperature of 30 ÷ 60 ° C followed by the addition of arasertaconazole mononitrate with vigorous stirring, the continuation of slow stirring until the mold temperature reaches a value of 30 ÷ 50 ° C, filling the molds with the resulting mass, cooling the soup ozitoriev in forms and sealing forms. ! 9. The method according to claim 8, in which the temperature during melting of the fat base is 40 ÷ 75 ° C. ! 10. The method of claim 8, in which the temperature pre