Kramzer Lindsay F, Cohen Jessica, Schubert Jesse, Dezzutti Charlene S, Moncla Bernard J, Friend David, Rohan Lisa C
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.
PATH, 2201 Westlake Avenue Suite 200, Seattle, WA, 98121, USA.
Contraception. 2015 Sep;92(3):254-60. doi: 10.1016/j.contraception.2015.05.005. Epub 2015 May 19.
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.
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.
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.
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.
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.
女用避孕套是一种新型女性避孕套，它使用可溶解的聚乙烯醇胶囊来简化阴道插入过程。这项临床前研究评估了将抗病毒药物UC781纳入女用避孕套胶囊的可行性，从而提供了一个独特的药物递送平台。
UC781胶囊采用女用避孕套胶囊开发过程中的方法以及阴道薄膜开发中使用的方法制造。对胶囊进行表征，以评估其物理/化学属性、与乳酸杆菌的兼容性、体外安全性和生物活性以及与避孕套的兼容性。
评估了两种UC781胶囊平台。平台1和平台2的胶囊质量（毫克；平均值±标准差）分别为116.50±18.22和93.80±8.49。厚度分别为0.0034±0.0004英寸和0.0033±0.0004英寸。崩解时间分别为11±3秒和5±1秒。穿刺强度分别为21.72±3.30牛和4.02±0.83牛。含水量分别为6.98±1.17%和7.04±1.92%。UC781含量分别为0.59±0.05毫克和0.77±0.11毫克。两个平台均保留了体外生物活性，并且对TZM-bl细胞和乳酸杆菌无毒。将UC781胶囊与女用避孕套包装一起短期储存不会降低避孕套的机械完整性。
UC781被装入了一种类似于女用避孕套产品的聚合物胶囊中。这项研究突出了女用避孕套作为与性/生殖健康相关药物（包括短期或长效艾滋病毒预防药物）阴道递送平台的潜在用途。
我们确定了将一种艾滋病毒预防杀微生物剂纳入女用避孕套胶囊的概念验证可行性。这项研究突出了各种体外物理和化学评估以及与女性性健康和生殖健康相关的阴道产品开发所需的生物活性和安全性评估。
