Over the past 20 years, few clinical areas have experienced faster growth than that of women’s health. In 1994, the FDA committed to a greater focus on women’s health with the establishment of the Office of Women’s Health (OWH), created to improve understanding and advance the treatment of women’s health issues. Since then, the study of women’s health issues and the development of women-specific medical devices and treatments have increased significantly.
Major progress in the areas of contraception, fibroids, urinary incontinence, pelvic prolapse and infertility has brought groundbreaking treatments and devices to market in recent years.
At MPI Research, we have been privileged to conduct studies and assist in the development of some of the most innovative women’s health devices and therapies. Highlighted below are two such studies:
- Engineering a Segmented 0Dual-Reservoir Polyurethane Intravaginal Ring for Simultaneous Prevention of HIV Transmission and Unwanted Pregnancy:
Sexually transmitted diseases, such as HIV/AIDS, and unwanted pregnancies continue to be prevalent among the general population, and drug and device development companies have increasingly focused on simultaneous prevention. Through a partnership between CONRAD, the University of Utah and Northwestern University, an intravaginal ring was recently developed to combat both issues. The ring delivers the HIV-1 reverse transcriptase inhibitor tenofovir and the contraceptive levonorgestrel for 90 days. MPI Research performed the pharmacokinetics studies and bioanalysis of the device. Leyonorgesterl segments placed intravaginally in rabbits resulted in sustained, dose-dependent levels of levonorgestrel in plasma and cervical tissue for 90 days. Polyurethane caps placed between segments successfully prevented diffusion of levonorgestrel into the tenofovir-releasing segment during storage. Testing of the device determined that it represents a significant advance in vaginal drug delivery technology and is the first in a new class of long-acting multipurpose preventive drug delivery systems.
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- Evaluation of Rapidly Disintegrating Vaginal Tablets of Tenofovir, Emtricitabine and Their Combination for HIV-1 Prevention:
As the prevalence of HIV remains disproportionally high in developing countries, there is a need for an effective – and easy to use – form of prevention. While gels are generally accepted by women, leakage is a common occurrence that may reduce the amount of drug at the sites of disease transmission. MPI Research partnered with CONRAD on the evaluation of combining their rapidly disintegrating vaginal tablets for the prevention of HIV-1. The resulting data demonstrated that the tablets may be a suitable topical microbicide dosage form providing similar vaginal TFV PK to that of TFV 1% gel. The data also supported co-administration of FTC with TFV in a single vaginal tablet to create a combination microbicide in a simple and inexpensive dosage form.
Click here for full study.