Use and composition of an anti-sexually transmitted diseases formulation

Abstract

The present invention provides a composition and use of a composition comprising a bioadhesive cross-linked polycarboxylic acid polymer formulation that enables the use of relatively low amounts of anti-STD infectants, such as N-9, to be used to prevent infection by STDs without causing the irritation to genital tissue that often accompanies higher doses of anti-STDs. The bioadhesive polymer maintains greater contact between the anti-STD agent and the infectant for a much greater period of time, enabling a lower concentration to act longer on the infectant, when compared to currently-available commercial applications containing N-9. Such delivery will enable a safe and non-irritating decrease in the risk of infection with STDs, including HIV.

What is claimed is:  
     
         1 . A method of delivering an anti-STD agent to a subject comprising inserting a bioadhesive cross-linked polycarboxylic acid polymer formulation with the anti-STD agent into a body cavity in an amount sufficient to demonstrate anti-STD activity without significant causation of irritation to the local epithelial tissues.  
     
     
         2 . A method according to    claim 1    wherein the polymer is polycarbophil.  
     
     
         3 . A method according to    claim 1    wherein the formulation includes at least one adjuvant.  
     
     
         4 . A method according to    claim 1    wherein the anti-STD agent is an anti-HIV agent.  
     
     
         5 . A method according to    claim 1    wherein the subject is a female.  
     
     
         6 . A method according to    claim 5    wherein the body cavity is the vagina.  
     
     
         7 . A method according to    claim 6    wherein the anti-STD agent is an anti-HIV agent.  
     
     
         8 . A method according to    claim 7    wherein the anti-STD agent is nonoxynol-9.  
     
     
         9 . A method according to    claim 8    wherein the polymer is polycarbophil.  
     
     
         10 . A method according to    claim 9    wherein about 52.5 mg. of N-9 is inserted into the vagina.  
     
     
         11 . A method according to    claim 10    wherein the formulation includes at least one adjuvant.  
     
     
         12 . A method according to    claim 11    wherein the formulation is a gel-like product which is provided with or in a single- or multi-dose disposable applicator.  
     
     
         13 . A drug delivery composition comprising a bioadhesive cross-linked polycarboxylic acid polymer formulation with an amount of an anti-STD agent sufficient, upon delivery to a body cavity, to demonstrate anti-STD activity without significant causation of irritation to the local epithelial tissues.  
     
     
         14 . A composition according to    claim 13    wherein the polymer is polycarbophil.  
     
     
         15 . A composition according to    claim 13    wherein the composition additionally comprises at least one adjuvant.  
     
     
         16 . A composition according to    claim 13    wherein the anti-STD agent is an anti-HIV agent.  
     
     
         17 . A composition according to    claim 16    wherein the anti-STD agent is N-9.  
     
     
         18 . A composition according to    claim 17    wherein the polymer is polycarbophil.  
     
     
         19 . A composition according to    claim 18    wherein the intended use of the composition is vaginal application.  
     
     
         20 . A composition according to    claim 19    wherein a single dose of the composition contains about 52.5 mg. of N-9, which dose is provided with or in a single- or multi-dose disposable applicator.  
     
     
         21 . An anti-STD bioadhesive composition comprising a cross-linked polycarboxylic acid polymer formulation.  
     
     
         22 . A bioadhesive drug delivery composition comprising a cross-linked polycarboxylic acid polymer and nonoxynol-9 formulation.