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Claims for Patent: 5,266,329

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Claims for Patent: 5,266,329

Title: Vaginal delivery system
Abstract:Systems and their methods of preparation and use that release an active agent in a controlled manner for an extended period in a vaginal cavity environment. When an antifungal agent such as an imidazole, is incorporated into the system it has been found that the conventional treatment time is reduced by at least 25%.
Inventor(s): Riley, Jr.; Thomas C. (St. Louis, MO)
Assignee: KV Pharmaceutical Company (St. Louis, MO)
Application Number:07/798,873
Patent Claims: 1. Vaginal delivery systems adapted for the treatment of fungal infections, which are bioadherent to the surfaces of a vaginal cavity comprising an active antimicrobial agent comprising an imidazole adapted to be released in a controlled manner to a location selected from the group consisting of a receptor site, site of action, site of absorption or site of use wherein said vaginal delivery systems comprise at least two phases, one phase comprises an external lipoidal phase and the other phase comprises an internal nonlipoidal phase wherein said lipoidal phases is continuous and the said nonlipoidal phases comprises at least 70% by volume of said systems, which vaginal delivery systems allow the overall treatment period or quantity of imidazole utilized to treat said fungal infection to be reduced by at least 25%.

2. The vaginal delivery systems of claim 1, wherein said phases form to comprise an emulsion, emulsion/dispersion, double emulsion, suspension within an emulsion or mixture.

3. A vaginal delivery drug system which comprise at least two phases, one phase comprises an external lipoidal phase and the other phase comprises an internal nonlipoidal phase wherein said lipoidal phases is continuous and the said nonlipoidal phases comprises at least 70% by volume of said system, which vaginal delivery system are for the treatment of microorganisms, wherein said vaginal drug delivery system is in a form selected from a liquid or semi-solid comprising a high internal phase ratio emulsion having an active antimicrobial agent present in an amount effective to reduce overall treatment period or quantity of active antimicrobial agent utilized by at least 25%.

4. A method of treating a vaginal fungal infection in a female human, which comprises: administering to the vaginal cavity of said human a therapeutically effective amount of a bioadherent, liquid or semi-solid vaginal delivery system comprising at least two phases, one phase comprises an external lipoidal phase and the other phase comprises an internal nonlipoidal phase wherein said lipoidal phases is continuous and the said nonlipoidal phases comprises at least 70% by volume of said systems, and which vaginal delivery system comprises a high internal phase ratio emulsion containing a therapeutically effective amount of an active antimicrobial agent comprising an antifungal agent, wherein the overall treatment period or quantity of antifungal agent utilized to treat said fungal infection is reduced by at least 25%.

5. The vaginal delivery systems of claim 1, wherein the active antimicrobial agent is an antifungal agent or an antibacterial agent.

6. The vaginal drug delivery system of claim 3, wherein the active antimicrobial agent is an antibacterial agent or an antifungal agent.

7. The method of treating a vaginal fungal infection of claim 4, wherein the active antimicrobial agent is an imidazole agent.
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