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Compsns-and methods for trapping and inactivating pathogenic microbes and spermatozoa

A composition, antimicrobial technology, applied in the direction of drug combination, organic active ingredients, sexual diseases, etc., can solve problems such as difficulty in use, reduced sexual pleasure and sensitivity, and less likely to be used

Inactive Publication Date: 2003-07-23
RUSH UNIV MEDICAL CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the use of such devices is likely to reduce sexual pleasure and sensitivity
Therefore, these devices are unlikely to be used on a permanent basis due to the difficulty of use, especially during "spurious" sexual activity

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Element

[0045] Gels containing varying levels of nonoxynol-9 (ie, about 0-10%) were prepared. The pH of the formulation was adjusted to pH about 3.5-3.6 with sodium hydroxide. Use this formulation to obtain high-quality capture gels. Additionally, unlike the formulation of Example 2, these formulations showed good stability over time even at levels of nonoxynol-9 up to about 5%.

[0046] As noted above, capture gels of the invention are generally prepared using conventional gel preparation techniques. It is however important to ensure that the buffer is completely soluble in the final product and air entrainment is avoided or at least kept to a minimum. This example provides several methods by which capture gels of the present invention can be prepared using laboratory-scale equipment. Of course, other methods (ie addition of components in a different order and variation of other parameters) can also be used as long as the resulting capture gel has sim...

Embodiment 5

[0067] Example 5. The capture gel of Example 1 containing 0, 2.5 and 5% nonoxynol-9 was tested for vaginal irritation in rabbits using a standard test protocol. The test substance / preparation (1 ml dose) was administered vaginally to rabbits for 10 consecutive days, and then the vaginal tissue was excised, fixed with buffered formalin, and three regions of the ventral vagina were subjected to histological examination. Fixed tissues were trimmed, sealed, embedded in paraffin blocks, sectioned and stained with hematoxylin and eosin. Sections were obtained from the anteroventral, medioventral, and retroventral vaginas. Histologic scoring is based on epithelial changes, vascular congestion, leukocyte infiltration, and edema. The total score was based on the maximum score on each scale, with a maximum of 16. Scores of 4 or less were considered minimally irritating, 5-8 mildly irritating, 9-11 moderately irritating, and 12-16 significantly irritating. A score of 0-8 is traditional...

Embodiment 6

[0071] Example 6. This example illustrates the anti-herpes activity of the gels of the invention, with and without nonoxynol-9 (N-9). The gel prepared in Example 1 was used. In vitro and in vivo studies were performed. The antiherpetic activity of the following formulations was evaluated:

[0072] (1) Gel of the present invention not containing Nonoxynol-9

[0073] (2) gel of the present invention containing 5% nonoxynol-9

[0074] (3) Gel of the present invention containing 2.5% nonoxynol-9

[0075] (4) K-Y Gel (Advanced Care Products) (Control 1)

[0076] (5) K-Y gel containing 2.2% nonoxynol-9 (Advanced Care Products; K-Y Plus TM ) (comparison 2)

[0077] (6) Phosphate buffered saline (PBS) (control 3).

[0078] in vitro studies. Dr. B. Herold, Mount Sinai School of Medicine, New York, NY, evaluated the in vitro activity of two gels of the invention with and without nonoxynol-9 against herpes virus. HSV-2 strain 186 was prepared by culturing in low-passage primary ...

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Abstract

Antimicrobial and contraceptive compositions and methods which prevent and / or reduce the risk of transmission of sexually transmitted diseases through sexual activity as well as prevent and / or reduce the risk of pregnancy are provided. The compositions contain (1) a matrix-forming agent, (2) a bio-adhesive agent, (3) a buffering agent, (4) optionally a humectant, (5) optionally a preservative, and (6) water; wherein the composition is suitable for application within the vagina; wherein the compositions form a semisolid matrix on contact with ejaculate (thereby trapping ejaculated microbes and spermatozoa); wherein the composition causes hardening of cervical mucus (thereby decreasing the probability of sperm entry); wherein the composition forms a bio-adhesive layer over vaginal surfaces (thereby preventing or reducing the risk of contact of STD-causing microbes with the vaginal surfaces); wherein the composition maintains an acidic vaginal pH of less than about 5 in the presence of semen ejaculated from the male; and wherein the composition does not significantly impair the natural microbiological balance within the vagina. The antimicrobial and contraceptive compositions may also contain additional antimicrobial and / or contraceptive agents (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride, phosphorylated hesperidins, sulfonated hesperidins, polystyrene sulfonates, substituted benzenesulfonic acid formaldehyde co-polymers, H2SO4-modified mandelic acids, povidone iodine, itraconazole, ketoconazole, metronidazole, clotrimazole, fluconazole, teraconazole, miconazole, tinidazole, iconazole, chloramphenicol, nystatin, cyclopiroxolamine, and the like).

Description

[0001] related application [0002] This application is based upon and claims the benefit of US Provisional Application Serial No. 60 / 187,574, filed March 7,2000. field of invention [0003] The present invention generally relates to compositions and methods for preventing the transmission of sexually transmitted diseases (STDs), and / or reducing the rate of transmission of these STDs in sexually active individuals. The present invention also generally relates to compositions and methods for preventing conception and / or reducing the risk of conception in sexually active females. While not wishing to be bound by theory, it is believed that the compositions of the present invention, when applied intravaginally during sexual intercourse, will physically capture and inactivate STD-related pathogens contained in ejaculated semen that may remain in the vagina Sexual microbes and sperm. The composition and method are particularly effective in preventing or reducing the possibility o...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/00A61K31/085A61K31/14A61K31/192A61K31/7048A61K31/795A61K47/10A61K47/12A61K47/18A61K47/36
CPCA61K31/00A61K31/192A61K31/795A61K47/12A61K31/14A61K31/7048A61K47/10A61K31/085A61K9/0034A61K47/36A61K47/183A61P15/18A61P31/00A61P31/18
Inventor S·加格L·J·D·赞费德R·A·小安德森D·P·沃勒
Owner RUSH UNIV MEDICAL CENT
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