Acceptability of Vaginal Film, Soft-Gel Capsule, and Tablet as Potential Microbicide Delivery Methods Among African Women

Abstract

All three dosage forms were acceptable to the women surveyed. Preferred dosage forms varied by country. These data suggest that the availability of microbicides in multiple dosage forms may increase acceptability, adherence, and, therefore, effectiveness.

Electrospun Solid Dispersions of Maraviroc for Rapid Intravaginal Preexposure Prophylaxis of HIV

“…Second, rapid hydration rates of fibers may minimize the risk of epithelial abrasions caused by the intravaginal dosage form if applied immediately before sex. The observation that fibers transform into a semisolid with gellike properties could prevent the sensation of "dry" sex often attributed to dry-dose microbicides (31). Also, since high-M w polymers (M w Ͼ 100 kDa) are utilized for electrospinning, the osmolality of dissolved fibers may be significantly lower than that of dissolved films incorporating lower-M w polymers (polyvinyl alcohol with M w of ϳ10 kDa) and excipients like PEG 400 and glycerol (ϳ10 to 100 times lower moles of solute per volume in fibers than in films).…”

Intravaginal Delivery Approaches for Contraception: An Overview with Emphasis on Gels

“…The film is folded once, placed over the dry finger and inserted high into the vagina. Besides, they offer various other advantages that include ease in use, no messiness, comfort, unimpeded sexual activity and reduced cost (34). The major components employed to develop vaginal films include active pharmaceutical ingredient (API), polymers that form water soluble film and plasticizers to increase elasticity (35).…”

Safety and Pharmacokinetics of Quick-Dissolving Polymeric Vaginal Films Delivering the Antiretroviral IQP-0528 for Preexposure Prophylaxis

“…The success with oral TDF and Truvada, TDF in combination with emtricitabine (FTC), in inhibiting HIV infection in nonhuman primates led to the clinical trials in humans with TDF and Truvada (1, 6-11). In stark contrast to the success of TDF and Truvada in clinical trials in men who have sex with men and heterosexual HIV-discordant couples, two large clinical trials in women with oral Truvada, VOICE and FEM-PrEP, have demonstrated no protection due to a lack of adherence (12, 13).Providing optimal dosage forms of potent HIV PrEP agents for women has the potential to improve product adherence (14,15). Topical dosage forms can be effective in reducing HIV infection, as demonstrated by the CAPRISA 004 vaginal 1% tenofovir (TFV) gel trial, where per-protocol use of the gel before and after sex with no more than 2 doses in 24 h (BAT-24) reduced HIV acquisition by 39% (2).…”

“…Providing optimal dosage forms of potent HIV PrEP agents for women has the potential to improve product adherence (14,15). Topical dosage forms can be effective in reducing HIV infection, as demonstrated by the CAPRISA 004 vaginal 1% tenofovir (TFV) gel trial, where per-protocol use of the gel before and after sex with no more than 2 doses in 24 h (BAT-24) reduced HIV acquisition by 39% (2).…”

“…A consumer product preference study conducted among 526 sexually active women in Burkina Faso, Tanzania, and Zambia reported that vaginal films and soft-gels were preferred over vaginal tablets due to the ease of insertion and faster dissolving time (15). Other promising attributes, such as no leakage, lack of feeling the product inside, likelihood to use the product in the future, and acceptability among their male partners were also described for the films (15). A vaginal contraceptive film (VCF) containing the spermicide nonoxynol-9 was the first commercially available film (25).…”