CHAPTER 10: Development of User-initiated Vaginal Dosage Forms

Women want to make their own choices about their sexual and reproductive health (SRH). To ensure that women can select from a variety of SRH products throughout their lifetime, product developers must provide safe, effective, accessible, and affordable options that run the gamut from provider-inserted, long-term implantable delivery systems and intrauterine devices to user-initiated, short-term vaginally inserted products. Most of the approved and currently marketed vaginally inserted products are used to prevent pregnancy or to treat either fungal or bacterial infections of the vagina or genitourinary syndrome of menopause. The approved products include vaginal films, inserts, and rings. However, none of the approved products prevent human immunodeficiency virus (HIV) infection or other sexually transmitted infections (STIs) or a combination of HIV, STIs, and pregnancy. This chapter will describe the unmet need for vaginally delivered products to help women achieve and maintain their SRH goals, the vaginal route of delivery and factors affecting drug absorption via vaginal delivery, and an overview of user-initiated vaginal dosage forms, such as rings, inserts, and films, that are either currently marketed or in clinical or preclinical development.