Technological and biological evaluation of tablets containing different strains of lactobacilli for vaginal administration.
Ten strains of lactobacilli were evaluated for the administration of viable microorganisms to restore the normal indigenous flora in the treatment of urogenital tract infections (UTI) in women. As the strains considered are facultative anaerobes, optimization of the production process was particularly critical to preserve bacterial viability. The microorganisms were formulated in single- and double-layer vaginal tablets. The two layers were characterized by different release properties: one is an effervescent composition that ensures a rapid and complete distribution of the active ingredient over the whole vaginal surface; while the second is a sustained release composition capable of releasing the lactobacilli over a longer period of time. Three different retarding polymers were tested, and all the formulations and tablets were evaluated in terms of technological processability, bacterial viability and stability, and cell adhesion properties of the microorganisms. From the results obtained, three out of ten strains appear particularly suitable for their application in the treatment of UTI. A larger batch of tablets made with a mixture of the three strains was then evaluated, confirming the feasibility of their industrial production and a good bacterial viability in the final dosage form.
Maggi
L
L
Department of Pharmaceutical Chemistry, University of Pavia, Pavia, Italy. lmaggi@chifar.unipv.it
Mastromarino
P
P
Macchia
S
S
Brigidi
P
P
Pirovano
F
F
Matteuzzi
D
D
Conte
U
U
D000282:Administration, Intravaginal; D001422:Bacterial Adhesion; D002448:Cell Adhesion; D002626:Chemistry, Pharmaceutical; D005260:Female; D005612:Freeze Drying; D006367:HeLa Cells; D006801:Humans; D007778:Lactobacillus / Q000737:chemistry* / Q000145:classification / Q000166:cytology*; D011108:Polymers / Q000494:pharmacology; D011208:Powders; D013535:Suspensions; D013607:Tablets; D014621:Vagina / Q000382:microbiology*
D011108:Polymers; D011208:Powders; D013535:Suspensions; D013607:Tablets