Nitrate Vaginal Suppositories

Scale (mg/ovule) Item Material Name Quantity/1000 Ovules (g) 

Fill weight 2700 mg per ovule. The following are additional requirements All particle sizes must be below 30 pm, and 60%-80% must be below 20 pm. 

Transfer the molten mass to the mixer through filter sieves. Set the temperature at 40° 2°C. 

Load item 1 to the mixer containing molten witepsol (items 2 and 3). 

Homogenise at high speed while mixing for 3 minutes. 

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Miconazole nitrate vaginal suppositories contain not less than 90% and not more than 110%i of the labeled amount of C18H14CI4N2O HNO3. 

Xue et al. [30] prepared a vaginal suppository formulation containing miconazole nitrate and determined its content by P-matrix ultraviolet spectrophotometry. The production of the suppository was finished with melting by the excipient of glyceryl esters fatty acid of artificial synthesis. Quantitative assay was conducted with a P-matrix ultraviolet spectrophotometer. The suppository was smooth and met the clinical requirement of vaginal disease treatment. The method of assay was accurate. 

Miconazole nitrate is available as an ointment, cream, solution, spray, or powder (micatin, monistat-DERM, Others). To avoid maceration, only the lotion should be applied to intertriginous areas. It is available as a 2% and 4% vaginal cream, and as 100-mg, 200-mg, or 1200-mg vaginal suppositories (monistat 7, MONiSTAr3, others), to be applied at bedtime for 7, 3, or 1 day(s), respectively. 

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