Development and Evaluation of a Suppository Formulation Containing Lactobacillus and Its Application in Vaginal Diseases

doi:10.1196/annals.1352.017

Lactobacillus has long been considered the protective florain the vagina that displaces and kills vaginal pathogens. Lacticacid, H₂O₂, and antibacterial agents such as lactocin and bacitracinproduced by Lactobacillus act against the vaginal pathogens.The first objective of this research was to develop a localapplication pharmaceutical formulation of a vaginal suppositorycontaining lyophilized culture of Lactobacillus. The secondobjective was to establish its in vivo performance by developingin vitro methods of evaluation. Lyophilized culture of Lactobacillussporogenes was selected for this study. Three formulations ofthe suppositories were prepared by the molding method. FormulationsI, II, and III contained cocoa butter, glycerinated gelatin,and PEG 1000 base, respectively. The prepared suppositorieswere characterized for physical properties. Assembly to simulatethe application site was designed. Methods to evaluate the viability,production of lactic acid, and H₂O₂ produced by the releasedLactobacillus at the application site were developed and theantagonistic activity was demonstrated. From the physical characteristicsof the suppository formulations, the glycerinated gelatin suppository(formulation II) containing lyophilized Lactobacillus was foundto be satisfactory. The developed assembly was satisfactoryin simulating the application site. The Lactobacillus releasedwas viable and exhibited the production of lactic acid, hydrogenperoxide, and antagonistic activity against the uropathogen.The suppository formulation containing Lactobacillus and themethods of its evaluation were successfully developed in thisresearch work and have several applications in the vaginal diseasesof women.