Lindsay F Kramzer1, Jessica Cohen2, Jesse Schubert2, Charlene S Dezzutti3, Bernard J Moncla3, David Friend4, Lisa C Rohan5. 1. 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. 2. PATH, 2201 Westlake Avenue Suite 200, Seattle, WA, 98121, USA. 3. 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. 4. CONRAD, 1911 North Fort Myer Drive Suite 900, Arlington, VA, 22209, USA. 5. 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.
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. STUDY DESIGN: 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. IMPLICATIONS: 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.
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. STUDY DESIGN: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. IMPLICATIONS: 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: Ian Major; Deborah Lowry; Karl Malcolm; David Woolfson; Jessica Cohen; Paul Labarre; Maggie Kilbourne-Brook; Gene Saxon; David Friend Journal: Annu Int Conf IEEE Eng Med Biol Soc Date: 2010
Authors: Charlene S Dezzutti; Lisa C Rohan; Lin Wang; Kevin Uranker; Cory Shetler; Marilyn Cost; J D Lynam; David Friend Journal: J Antimicrob Chemother Date: 2012-05-11 Impact factor: 5.790
Authors: Alexander M Cole; Dorothy L Patton; Lisa C Rohan; Amy L Cole; Yvonne Cosgrove-Sweeney; Nicole A Rogers; Deena Ratner; Alexandra B Sassi; Carol Lackman-Smith; Patrick Tarwater; Bharat Ramratnam; Piotr Ruchala; Robert I Lehrer; Alan J Waring; Phalguni Gupta Journal: PLoS One Date: 2010-11-29 Impact factor: 3.240
Authors: Mags E Beksinska; Gilda Piaggio; Jennifer A Smit; Junqing Wu; Yufeng Zhang; Jacqueline Pienaar; Ross Greener; Ying Zhou; Carol Joanis Journal: Lancet Glob Health Date: 2013-08-23 Impact factor: 26.763
Authors: D'Nyce L Williams; Daniel R Newman; Susan A Ballagh; Mitchell D Creinin; Kurt Barnhart; Debra H Weiner; April J Bell; Denise J Jamieson Journal: Sex Transm Dis Date: 2007-12 Impact factor: 2.830
Authors: Ana Ventuneac; Alex Carballo-Diéguez; Ian McGowan; Robert Dennis; Amy Adler; Elena Khanukhova; Charles Price; Terry Saunders; Chomchay Siboliban; Peter Anton Journal: AIDS Behav Date: 2009-09-11
Authors: Beatrice A Chen; Diana L Blithe; Gitonga R Muraguri; Audrey A Lance; Bruce R Carr; Jeffrey T Jensen; Thomas D Kimble; Amitasrigowri S Murthy; Courtney A Schreiber; Michael A Thomas; Terri L Walsh; Carolyn Westhoff; Anne E Burke Journal: Contraception Date: 2019-03-06 Impact factor: 3.375