Innovative Approach to Vaginal Drug Delivery

Abstract

Shihata Alfred A, Brody Steven

Introduction: The vagina is an ideal site for drug delivery, particularly for those drugs associated with women’s reproductive health. For years traditional applicators have been the primary method used to deliver therapeutic creams into the vagina. The applicator’s lack of efficacy is mainly attributed to the vagina’s rhythmic muscular contractions, which naturally flush out any substances from its canal. As a self-cleaning organ; the vagina not only expels cervical secretions and menstrual blood, but also any therapeutic creams, which will render them less effective.

Objectives: To provide women with an alternative to vaginal applicators, which will increase the time of contact between the therapeutic vaginal preparations and the cervix. Explore the possibility of topical treatment of Bacterial Vaginosis and Candida infections using a new cervical barrier called FemCap; where it is used as a delivery system for antibacterial and antifungal preparations.

Methodology: To prove this concept we recruited 30 women to insert a stained gel (Gentian Violet dye) with a vaginal applicator and another 30 women to insert the same gel with the FemCap. We then compared the retention and distribution of the stained gel over the cervix and we photographed the cervices at 12 and 24 hours.

Results: None of the participants reported any side effects using the stained gel with either device. Women reported leakage while using the vaginal applicator and did not have any with the FemCap. Women who used the applicator had no visible stained gel over the cervix after 12 hours of insertion. Cervical photographs have shown that the FemCap participants retained the stained gel on the cervix more than 24 hours after insertion.

Conclusion: This pilot study has proved the concept that FemCap is more efficient than the vaginal applicator in delivering vaginal preparations to cervix and vagina. The FemCap can shield the cervix from sperm penetration and potentially from STI organism’s invasion. Further studies should be conducted to explore the possibility of treating Bacterial Vaginosis, Candida topically and some STIs.

PDF