SBIR-STTR Award

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.

Public Health Relevance Statement:
Project Narrative The lack of adequate condom lubrication remains to be a major leading problem for consistent and proper condom usage worldwide according to the World Health Organization. The HydroGlyde Coating is a unique and durable hydrophilic coating on latex condoms that can maintain its lubricity when in contact with water which will promote consistent and proper condom usage, while improving user satisfaction. The objective for this SBIR Phase I proposal is to translate our HydroGlyde Coating laboratory prototype towards an industry prototype that is adaptable towards large-scale manufacturing under GMP standards and to characterize this prototype.  

Project Terms:
abstracting; acrylic acid; Address; Affect; Application procedure; assay development; base; Benzophenones; biocoating; Biocompatible; biomaterial compatibility; Boston; Cell Line; Collaborations; condoms; consistent condom use; Consumer Satisfaction; Contracts; cytotoxicity; Data; Development Plans; Dryness; Ensure; Epithelial Cells; Fee-for-Service Plans; Free Radicals; Friction; General Population; Goals; Guidelines; HIV; human subject; Image; improved; In Vitro; Industry; Inflammation; Institutional Review Boards; interest; irritation; Laboratories; Latex; Legal patent; Life; Light; Liquid substance; Lubricants; Lubrication; male; Marketing; Measurement; Measures; Mechanics; Medical Device; Menopause; novel; Pain; Phase; Play; pleasure; polymerization; Postmenopause; preference; Preparation; Process; Property; prototype; Risk; Role; safety study; Sampling; satisfaction; Series; Sexually Transmitted Diseases; Silicones; Small Business Innovation Research Grant; social stigma; Staging; Surface; Surveys; Technology; Testing; Thick; Time; Tissues; Touch sensation; Translating; Universities; Unwanted pregnancy; UV induced; UV Radiation Exposure; Vagina; Water; willingness; Woman; World Health Organization

The sexual health crisis associated with STI transmission is a $16 Billion economic burden in the American healthcare system (Center of Disease Control). There are about 1 Billion unprotected sex acts with 20 Million new STI cases each year in the US. This epidemic is also a global problem with rising rates of 498 Million new cases of STI transmission per year with 2.1 Million of these cases associated with HIV. The use of condoms is the best prevention method to minimize the spread of STI. However the lack of adequate lubrication still remains to be a major universal drawback for consistent and correct condom use. In addition to increased risks for STI transmission, inadequately lubricious condoms result in mucosal microtrauma, pain, increased chances of condom breakage, and decreased satisfaction between partners. Thus, the HydroGlyde Coating was developed in response to the clear clinical and market need to improve condoms as the last significant technological improvements was more than 50 years ago (i.e. introduction of silicone fluids as lubricants). The HydroGlyde Coating is the first of its kind and represents a significant departure from all conventional latex condoms by eliminating the need for supplemental personal lubricants and offering longer-lasting lubricity. The technological advantages include: 1) reduce mucosal microtrauma and frictional forces between the condom and tissue interface; 2) increase correct condom usage; 3) improve user satisfaction and pleasure for intercourse; and importantly, 4) an innovative solution to address health concerns of preventing the spread of STIs and unwanted pregnancies. The successful completion of our Phase I validated the coating formulation to be scalable and that HydroGlyde condoms are fabricated with consistent reproducibility under GMP-like conditions using our second-generation coating prototype (HGCoat_2). The aims of our Phase II proposal are: 1) development and scale-up of the HydroGlyde Coating formulation and execution of trial runs in a large-scale condom manufacturing facility to produce HydroGlyde condoms under GMP standards (GPC/Karex); 2) evaluation of the mechanical properties and biocompatibility of HydroGlyde condoms in accordance to ISO 10993 and ISO 4074 for the preparation and filing of a 510(k) for FDA clearance; and, 3) perform an IRB-approved marketing study with human subjects to obtain consumer feedback on HydroGlyde condoms. Completion of these studies will position us to gain FDA approval for HydroGlyde condoms, expand our HydroGlyde team, and initiate sales. The commercialization and introduction of this innovative condom coating technology to the market will offer a viable solution to address current health challenges by offering an improved condom product with superior, durable lubrication in order to promote correct and consistent usage.

Thesaurus Terms:
Address; Affect; American; Aqueous; Atrophic; Base; Biological; Biomaterial Compatibility; Cells; Centers For Disease Control And Prevention (U.S.); Clinical; Commercialization; Condoms; Consistent Condom Use; Cost; Design; Development; Economic Burden; Epidemic; Evaluation; Feedback; Formulation; Friction; Generations; Glass; Global Health; Goals; Health; Healthcare Systems; Hiv; Human; Human Subject; Hydrophilicity; Improved; Industry; Innovation; Institutional Review Boards; Laboratories; Latex; Liquid Substance; Lubricants; Lubrication; Manufacturing Facility; Marketing; Mechanical Properties; Mechanics; Medical; Menopause; Methods; Mucous Membrane; Oils; Outcome; Pain; Phase; Pleasure; Positioning Attribute; Postmenopause; Preparation; Prevent; Prevention; Prototype; Reapplication; Rectal; Reproducibility; Response; Risk; Running; Safety; Sales; Satisfaction; Scale Up; Series; Sexual Health; Silicon; Silicones; Small Business Innovation Research Grant; Sti Prevention; Surface; Technology; Testing; Tissues; Translations; Transmission Process; Unsafe Sex; Unwanted Pregnancy; Vagina; Water; Woman;