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 (PVA) 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 sec and 5 ± 1 sec. 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 non-toxic 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.

Acceptability of the Woman's Condom in a phase III multicenter open-label study

“…However, not every woman wants a LARC or a hormonal contraceptive; the potential for STI and HIV protection makes female condoms one of few methods that can offer dual protection. In addition, the WC holds promise for vaginal delivery of HIV and STI prevention medications [27]. Female-controlled methods that can protect against STI, HIV, and pregnancy would be a boon.…”

A novel method to enhance efficacy of topical drugs by condom occlusion in penile dermatoses

“…We propose a simple solution to this problem by asking patient to wear a condom after application of the drug. Condoms have already been used for drug delivery in males and females, notably for the containment and focused delivery of spermicides, vasodilators such as niacin, sildenafil citrate and nitroglycerin and male desensitising agents such as benzocaine,1 but we could not find a well-documented case in which condoms were used to increase the therapeutic efficacy of drugs to treat penile dermatoses. In case of lesions on glans penis, condom should be worn after retracting the prepuce and applying the drug.…”

Pipeline for contraceptive development

“…Early phase clinical studies of the rings are ongoing. Potential barrier methods include the SILCS diaphragm, combined with active antiviral agents such as Tenofovir gel (42), and the new Women’s Condom (45); both developed by PATH.…”