Pharmaceutical compositions containing lactobacilli for treatment of vaginal infections and related method

a technology of vaginal infections and compositions, which is applied in the direction of bacterial antigen ingredients, plant growth regulators, biocide, etc., can solve the problems of difficult treatment of genital system infections by administering antibiotics, development of more serious infections of the genital system, lactobacilli in pharmaceutical compositions of the known art, made in the form of pessaries or tablets for vaginal use, etc., and achieves efficient treatment

Inactive Publication Date: 2007-10-23
DE SIMONE CLAUDIO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0025]Therefore, it is an object of the present invention to provide lactobacilli-based pharmaceutical compositions meeting the above features to the highest possible degree, and therefore adapted to be efficiently employed for treatment of vaginal infections, such as vaginitis and vaginosis, for example. In this connection the Applicants have found the lactobacilli of the Lactobacillus brevis and Lactobacillus salivarius subs. salicinius species meet the whole of the above three features to a greatly higher degree than other lactobacillus species.
[0027]It is a further object of the invention to provide solid pharmaceutical compositions capable fo releasing lactobacilli carried therein in a differentiated manner in time.

Problems solved by technology

Although bacterial vaginosis is slightly troublesome, it may predispose to development of more serious infections of the genital system, in particular during pregnancy.
Unfortunately, pathogenic bacteria (Staphylococcus, for example) can acquire a resistance to antibiotics and thus make it difficult to treat these diseases by administering antibiotics.
Pharmaceutical compositions of the known art, made in the form of pessaries or tablets for vaginal use, containing lactobacilli, are not sufficiently efficient in re-establishing the vagina colonization.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Adhesion Lactobacilli to HeLa Cells

[0048]By this test there was examined the capability of different strains of Lactobacilli from the American Type Culture Collection (ATCC) to adhere to HeLa cells, a cell line originating from a human carcinoma of the uterine neck. HeLa cells were maintained as monolayer in tissue-culture bottles in MEM (Minimal Essential Medium) with addition of 10% (v / v) fetal bovine serum (FBS). The adhesion reaction was carried out in a multiple-well culture plate for tissues containing a sterile covering slide (24×24 mm) in each well. In each well 1 ml of HeLa cell suspension at a concentration of 1.2×105 cells / ml was sown and the plates were incubated for 24 hours at 37° C. in a 5% CO2 atmosphere. Before the adhesion test, all bacterial strains were placed in a MRS broth sub-culture (Difco). After a 24 hour incubation at 37° C. under anaerobic conditions (15% CO2) the bacteria were “strengthened” in a new broth and then incubated overnight under the same expe...

example 2

Anti Candida Effect of Lactobacilli

[0052]The capability of various lactobacillus species of interfering in a competitive manner with adhesion of the Candida albicans (and therefore on the Candida albicans infectiveness) to HeLa cells was examined.

[0053]In order to evaluate the lactobacillus influence on the adhesion level of Mycetes (C. albicans) to host cells, mono-layer HeLa cells, grown up in 24-well plates containing sterile covering slides were inoculated with 0.1 ml of a mixture of lactobacilli and C. albicans (two clinical samples isolated from a human vagina referred to in this study as CA2 and CA3, respectively) diluted in PBS at final concentrations of 5×109 bacteria / ml and 5×108 Mycetes / ml, respectively. After one hour of incubation at 37° C. under microaerophilic conditions, cells were washed five times in PBS set with May Grunwald and Giemsa. Then slides were controlled with an optical microscope (1000×magnification) and the level of microorganisms adhering to HeLa cell...

example 3

Production of Hydrogen Peroxide by Lactobacilli

[0056]The capability of five lactobacilli species of producing H2O2 was examined. Bacteria were placed for culture on an agar-agar plate with tetramethylbenzidine. After three days of incubation at 37° C. in a jar under anaerobic conditions, the agar-agar plates were exposed to the air. In this way, the peroxidase present in the culture medium reacts with the H2O2 produced by lactobacilli. The subsequent oxidation of tetramethylbenzidine is revealed by a blue pigmentation of the H2O2-producing colonies. The obtained results, set forth in Table 3, show that L. salivarius subs. salicinius ATCC 11742 and L. gasseri ATCC 3857 were positive to H2O2.

[0057]L. casei ATCC 8530 did not show any positivity. The other tested strains were devoid of any reaction. These results show that no correlation exists between the H2O2 production by lactobacilli and the competitive exclusion of the C. albicans adhesion to HeLa cells by bacteria.

[0058]

TABLE 3Pro...

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Abstract

Use of an association of lactobacilli for preparation of a pharmaceutical composition for treatment of vaginosis and vaginitis. Said bacteria association comprises the Lactobacillus brevis and Lactobacillus salivarius subs. salicinius species, possibly in combination with one or more species selected from Lactobacillus salivarius subs. salivarius, Lactobacillus jensenii, Lactobacillus catenaforme, Lactobacillus minutus and Lactobacillus gasseri.A pharmaceutical composition comprising said association of lactobacilli adapted for treatment of vaginosis and vaginitis.A method of treating vaginosis and vaginitis based on administration of said pharmaceutical composition.

Description

FIELD AND BACKGROUND OF THE INVENTION[0001]The present invention relates to the use of particular species of lactobacilli for preparing pharmaceutical compositions for treatment of vaginal infections, as well as to the pharmaceutical compositions thus prepared, and to methods of treating vaginal infections by administration of said compositions.[0002]Normal vagina and normal uterine neck lodge a variety of bacteria assimilable to those of the gastrointestinal system. These bacteria are frequently involved in non-gonococcus infections of the feminine genital system (such as, for example: vulvovaginal abscesses and abscesses of Bartholin's (or greater vestibular) gland, endometritis, salpingitis, ovary abscesses and pelvic peritonitis).[0003]In the progress of inflammatory pelvic diseases of non-venereal nature, often a mixture of anaerobic and aerobic bacteria is found; such a bacteria range may be responsible of infections after gynecological operations, childbirth, abortion, and ha...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): C12N1/20A61K9/00A61K9/20A61K31/00A61K35/74A61P15/00A61P15/02A61P31/00A61P31/04
CPCA61K9/0007A61K9/0034A61K9/2054A61K9/209A61K35/747A61P15/00A61P15/02A61P17/00A61P31/00A61P31/04A61P31/08A61P31/10A61K2300/00A61K39/07
Inventor DE SIMONE, CLAUDIO
Owner DE SIMONE CLAUDIO
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