A new condom design for encouraging correct and consistent use

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Abstract The lack of adequate lubrication is a major universal drawback for consistent and correct condom use. Consequently, improper condom usage leads to increased risks for the spread of STIs, including HIV. Inadequately lubricious condoms can also result in mucosal microtrauma, pain, increased chances of condom breakage, and decreased satisfaction between partners. The HydroGlyde Coating addresses these issues by providing uninterrupted superior lubrication that is activated with water thereby eliminating the need for additional lubrication to maintain the condom's lubricity. We expect that our novel self- lubricating coating technology will: 1) alter the negative societal stigma regarding condom usage; 2) encourage correct and consistent condom use and usage desirability; 3) reduce mucosal microtrauma; 4) decrease unwanted pregnancies and spread of STIs and STDs; and, 5) improve user satisfaction. We have developed and characterized the HydroGlyde Coating for latex condoms, as well as performed an IRB-approved touch- test survey which found human subject preference for the HydroGlyde coated condoms over non-lubricated latex samples or samples lubricated with KY® Liquid. These results projected the general population's interests in this technology, providing optimistic willingness to accept HydroGlyde coated condoms if introduced to the market. Our goal is to fabricate the HydroGlyde Coating prototype and coating application procedure to be adaptable towards large-scale manufacturing under GMP standards. We will collaborate with Biocoat Inc. and Boston University to complete the following aims: SPECIFIC AIM 1: Transition of the HydroGlyde Coating technology prototype and application process on male latex condoms to an industrial prototype under the coating expertise of Biocoat Inc. SPECIFIC AIM 2: (a) Assess the physical, biocompatible, mechanical, and durability properties of the HydroGlyde coated male latex condoms in comparison to commercially available lubrications and lubricated condoms; (b) investigate in vitro cytotoxicity of potential leachables in an epithelial cell line via an MTS transwell assay Development Plan. Successful completion of these aims will be critical for a Phase II SBIR application which will focus on: 1) biocompatibility and safety studies at TOXICON; 2) ISO testing; 3) accelerated stability and shelf-life studies; and 4) packing under GLP at GPC/Karax Berhad.