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Claims for Patent: 4,551,148

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Claims for Patent: 4,551,148

Title: Vaginal delivery systems and their methods of preparation and use
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. The systems are capable of delivering the active agent for periods greater than three hours at a predictable rate to a predetermined site, the vaginal cavity.
Inventor(s): Riley, Jr.; Thomas C. (Manchester, MO), Tharp; Charles P. (Belleville, IL), Lapka; Galen G. (St. Louis, MO)
Assignee: KV Pharmaceutical Company (St. Louis, MO)
Application Number:06/663,145
Patent Claims: 1. Vaginal delivery systems which are bioadherent to the vaginal surfaces and which release an active agent in a controlled manner for at least three hours to a receptor site, site of action, site of absorption, or site of use consisting essentially of liquid or semi-solid adjacent unit cells having common lipoidal external phases, nonlipoidal internal phases and emulsifiers.

2. The vaginal delivery systems of claim 1 wherein said phases form a liquid or semi-solid.

3. 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.

4. The vaginal delivery systems of claim 1 wherein at least a portion of the active agent is contained in said nonlipoidal phases.

5. The vaginal delivery systems of claim 1 wherein the active agent comprises nonoxynol-9.

6. The vaginal delivery systems of claim 1 wherein the active agent comprises nystatin.

7. The vaginal delivery systems of claim 1 wherein the active agent comprises a pH buffer.

8. The vaginal delivery systems of claim 1 wherein said nonlipoidal phases comprise at least 70% by volume of said systems.

9. The vaginal delivery systems of claim 1 wherein said nonlipoidal phases comprise either water, glycerine or a combination thereof.
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