title: Assessing the potential of the Woman's Condom for vaginal drug delivery.
abstract: BACKGROUND
  The Woman's Condom is a new female condom that uses a dissolvable polyvinyl alcohol capsule to simplify vaginal insertion. This preclinical study assessed the feasibility to incorporate an antiviral drug, UC781, into the Woman's Condom capsule, offering a unique drug delivery platform.
  
  
  METHODS
  UC781 capsules were fabricated using methods from the development of the Woman's Condom capsules as well as those used in vaginal film development. Capsules were characterized to evaluate physical/chemical attributes, Lactobacillus compatibility, in vitro safety and bioactivity, and condom compatibility.
  
  
  RESULTS
  Two UC781 capsule platforms were assessed. Capsule masses (mg; mean±SD) for platforms 1 and 2 were 116.50±18.22 and 93.80±8.49, respectively. Thicknesses were 0.0034±0.0004 in and 0.0033±0.0004 in. Disintegration times were 11±3 s and 5±1 s. Puncture strengths were 21.72±3.30 N and 4.02±0.83 N. Water content measured 6.98±1.17% and 7.04±1.92%. UC781 content was 0.59±0.05 mg and 0.77±0.11 mg. Both platforms retained in vitro bioactivity and were nontoxic to TZM-bl cells and Lactobacillus. Short-term storage of UC781 capsules with the Woman's Condom pouch did not decrease condom mechanical integrity.
  
  
  CONCLUSIONS
  UC781 was loaded into a polymeric capsule similar to that of the Woman's Condom product. This study highlights the potential use of the Woman's Condom as a platform for vaginal delivery of drugs relevant to sexual/reproductive health, including those for short- or long-acting HIV prevention.
  
  
  CONCLUSIONS
  We determined the proof-of-concept feasibility of incorporation of an HIV-preventative microbicide into the Woman's Condom capsule. This study highlights various in vitro physical and chemical evaluations as well as bioactivity and safety assessments necessary for vaginal product development related to female sexual and reproductive health.
authors.affiliation: Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, 3501 Terrace Street, Pittsburgh, PA, 15261, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, 15213, USA.
authors.forename: Lindsay F
authors.initials: LF
authors.lastname: Kramzer
authors.affiliation: PATH, 2201 Westlake Avenue Suite 200, Seattle, WA, 98121, USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Cohen
authors.affiliation: PATH, 2201 Westlake Avenue Suite 200, Seattle, WA, 98121, USA.
authors.forename: Jesse
authors.initials: J
authors.lastname: Schubert
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, M240 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, 15213, USA.
authors.forename: Charlene S
authors.initials: CS
authors.lastname: Dezzutti
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, M240 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, 15213, USA.
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Moncla
authors.affiliation: CONRAD, 1911 North Fort Myer Drive Suite 900, Arlington, VA, 22209, USA.
authors.forename: David
authors.initials: D
authors.lastname: Friend
authors.affiliation: Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, 3501 Terrace Street, Pittsburgh, PA, 15261, USA; Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, M240 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA, 15261, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, 15213, USA. Electronic address: rohanlc@upmc.edu.
authors.forename: Lisa C
authors.initials: LC
authors.lastname: Rohan
mesh_terms: D000282:Administration, Intravaginal; D000813:Anilides / Q000008:administration & dosage*; D000998:Antiviral Agents / Q000008:administration & dosage*; D019111:Single-Use Internal Condom / Q000191:economics*; D016503:Drug Delivery Systems / Q000379:methods*; D004353:Drug Evaluation, Preclinical; D005260:Female; D005663:Furans / Q000008:administration & dosage*; D006367:HeLa Cells; D006801:Humans; D013854:Thioamides
chemical_list: D000813:Anilides; D000998:Antiviral Agents; D005663:Furans; D013854:Thioamides; C100668:UC-781
keywords: Contraception; HIV prevention; Microbicide; Topical preexposure prophylaxis; UC781; Woman’s Condom