Graduate Thesis Or Dissertation
 

Antimicrobial vaginal dosage forms employing Dimethyl Fumarate or propionic acid

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  • Propionic acid, live Propionibacterium shermanii, and Dimethyl Fumarate (DMF) were tested for their stimulatory or inhibitory efects on yeast, bacteria, and molds. The amount of propionic acid required for inhibition of molds was strain specific and equal to or less than that required for inhibition of the yeasts. Live P. shermanii cultures grown for 96 hours inhibited the growth of yeast and one species of bacteria but were not effective against molds. DMF inhibited all the species against which it was tested and is proposed to be a potent medicinal agent for treatment of vaginal and topical infections. Stability testing of DMF in human plasma, rabbit blood, human vaginal secretions (in normal saline), normal saline, and in water maintained at 85°C and 45°C was conducted. Degradation of DMF followed first order kinetics in human plasma and had a half life of about 154 minutes. Degradation of DMF in rabbit blood could be fit to a second order kinetic model and had an approximate half life of 10 minutes. DMF had a half life of about 21 hrs in vaginal secretions whereas only 25 percent DMF degraded in 22 hours in normal saline. In water, ninety-five percent of DMF degraded at 85°C, whereas 72 percent DMF remained intact at 45°C at the end of an eight week period. An attempt was made to study the pharmacokinetics of DMF in rabbits by administering DMF orally and as an intra venous infusion. Detectable amounts of DMF were not found in rabbit blood. Dosage forms containing DMF or propionic acid were pre pared and buffered at pH 4.5. Suppositories, ointments and foam aerosols were tested against Candida utilis. The sup pository containing DMF inhibited the yeast growth completely. Aerosols also inhibited the growth of yeasts at higher dilutions, but at lower dilutions there was growth observed at the edges of the plates indicating uneven spraying of aerosols. Ointment containing 3% propionic acid inhibited C. utilis completely whereas 0.5% DMF did not inhibit the yeast growth, which is surprising, and may indicate either that degradaton of DMF had occured or DMF was not released from the vehicle. This was a broad preliminary study of propionic acid, DMF, and metabolites of Propionibacterium shermanii as potential medicinal agents and gives guidance for further detailed investigation of these compounds.
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