Universal vaginal applicator for the uniform distribution of vaginal gel and cream formulations: a magnetic resonance imaging study.

OBJECTIVE: Conventional vaginal applicators with a single apical hole do not distribute vaginal formulations homogenously and do not cover the entire vaginal and cervical mucosa. To overcome this problem and offer women further protection against vaginal infections, we designed a unique vaginal applicator with multiple apical and lateral holes. We have previously shown that the new applicator distributes an investigational vaginal gel homogenously over the entire vaginal and cervical mucosa. In this study, we investigated (using MRI) whether the new applicator works as well with marketed vaginal gels and creams. METHODS: Eighteen women participated in the study and six vaginal gels and creams were tested. Each woman used a marketed vaginal product with its own commercial applicator (CA) once and with our universal vaginal applicator (UVA) once to deliver the same product. The applications were separated by a one-week period. Pelvic MRI was performed immediately after vaginal application to evaluate the product's distribution and mucosal coverage. RESULTS: Immediately after application of the vaginal product, the UVA homogenously distributed the six products (3 gels and 3 creams) over the entire vaginal and cervical mucosa. On the other hand, the tested CA delivered four products (3 gels and 1 cream) mainly to the cervix and the upper vagina, but not to the mid and lower vagina; for the other two creams, the distribution was similar to that of UVA. Furthermore, the UVA received the highest acceptability score. CONCLUSION: The UVA can be used to deliver different vaginal gel and cream products homogenously throughout the vagina. This was the first time the UVA had been tested with marketed vaginal gels and creams. This applicator, giving uniform mucosal coverage and being highly acceptable, may help women to better protect themselves against sexually transmitted infections.

Objectif : Les applicateurs vaginaux conventionnels dotés d'un seul orifice apical ne permettent pas de distribuer les formulations vaginales de façon homogène et ne couvrent pas l'intégralité de la muqueuse vaginale et cervicale. Pour surmonter ce problème et offrir aux femmes davantage de protection contre les infections vaginales, nous avons conçu un applicateur vaginal unique en son genre doté de multiples orifices apicaux et latéraux. Nous avons déjà démontré que ce nouvel applicateur permettait de distribuer un gel vaginal expérimental de façon homogène sur l'intégralité de la muqueuse vaginale et cervicale. Dans le cadre de cette étude, nous nous sommes penchés (en ayant recours à l'IRM) sur la question de savoir si ce nouvel applicateur fonctionnait tout aussi bien dans le cas des crèmes et des gels vaginaux offerts sur le marché. Méthodes : Dix-huit femmes ont participé à l'étude et six crèmes et gels vaginaux ont été mis à l'essai. Chacune de ces femmes a utilisé à deux reprises un même produit vaginal offert sur le marché : une fois au moyen de l'applicateur commercial fourni par le fabricant (AC) et une autre fois au moyen de notre applicateur vaginal universel (AVU). Une période d'une semaine séparait ces deux applications. Une IRM pelvienne a été menée immédiatement à la suite de chacune de ces applications vaginales afin d'évaluer la distribution du produit et l'aire couverte en ce qui concerne la muqueuse. Résultats : Immédiatement à la suite de l'application du produit vaginal, nous avons constaté que l'utilisation de l'AVU permettait la distribution homogène des six produits (trois gels et trois crèmes) sur l'intégralité de la muqueuse vaginale et cervicale. En revanche, dans le cas de quatre des produits en question (trois gels et une crème), l'AC mis à l'essai a donné lieu à une distribution ayant principalement atteint le col utérin et la partie supérieure du vagin (excluant ainsi les parties intermédiaire et inférieure du vagin); pour ce qui est des deux autres crèmes, la distribution obtenue était semblable à celle qu'a permise l'AVU. De surcroît, l'AVU a obtenu le score d'acceptabilité le plus élevé. Conclusion : L'AVU peut être utilisé pour assurer l'administration de divers produits vaginaux en gel et en crème de façon homogène dans tout le vagin. Il s'agissait de la première mise à l'essai de l'AVU au moyen de crèmes et de gels vaginaux offerts sur le marché. Cet applicateur, qui permet de couvrir l'aire muqueuse de façon uniforme et qui compte une acceptabilité élevée, pourrait aider les femmes à mieux se protéger contre les infections transmissibles sexuellement.

Distribution of a vaginal gel (Invisible Condom) before, during and after simulated sexual intercourse and its persistence when delivered by two different vaginal applicators: a magnetic resonance imaging study.

OBJECTIVE: The objective of this study was to evaluate the vaginal distribution of a microbicidal gel (Invisible Condom) before, during and after simulated intercourse using an artificial phallus. The gel was delivered using either a new proprietary vaginal applicator (PVA), which has multiple lateral and apical holes, or a commercial applicator (CA), which has a single apical hole. The persistence of the gel was evaluated up to 24 h after its administration. STUDY DESIGN: Nine women (five women using the PVA and four women using the CA) applied the vaginal gel once, and pelvic images were taken immediately after application. An artificial phallus was inserted and the women had 30 vaginal thrusts, then another set of images was taken while the phallus was still inside the vagina. On exit of the phallus, one more set of images was taken. Images were subsequently taken at 30 min, 2 h, 6 h and 24 h after gel application. RESULTS: Immediately after gel application, the PVA distributed the gel throughout the vaginal/cervical mucosae, while the CA delivered the gel only to the cervical area. During simulated intercourse, the phallus further pushed the gel delivered with the CA into the fornix, whereas it spread the gel delivered with the PVA more evenly throughout the mucosal surface. After simulated intercourse, both applicators gave similar gel distributions between 30 min and 6 h after application. However, at 24 h, using the PVA, only 5% of the gel persisted in the vagina, compared to 40% of the gel using the CA. DISCUSSION AND CONCLUSION: Using the new PVA, the Invisible Condom covered the vaginal/cervical mucosae before and during simulated intercourse, offering immediate protection, whereas only the cervical mucosa was covered using the CA. Forty percent of the gel persisted mostly in the upper vaginal/cervical area at 24 h following its administration with the CA, while only 5% of the gel was left using the PVA. The new applicator, with its unique design, ensures an even and immediate coating lasting throughout the first 6 h and could prevent potential microbicide vaginal toxicity at 24 h.