Qualitative exploration of intrinsic and extrinsic factors that influence acceptability of semisoft vaginal suppositories.

BACKGROUND: Vaginal microbicides are a promising means to prevent the transmission of HIV and other sexually transmitted infections, by empowering women to initiate use prophylactically when they perceive themselves to be at risk. However, in clinical trials, microbicides have shown mixed results, with the consistent finding that effectiveness varies substantially as a function of user adherence. METHODS: Based on the assumption that adherence is driven, at least in part, by product properties that influence acceptability, we used softgel technology to develop vaginal drug delivery systems in the intermediate texture space between solids and liquids to overcome potential shortcomings of current dosage forms. Here, we used focus groups and surveys to determine women's initial reactions (i.e., acceptance and willingness-to-try) for semisoft vaginal suppositories intended for HIV and STI prevention, with a specific focus on how perception of and preferences for vaginal suppositories may be influenced by product characteristics such as size, shape, and firmness. RESULTS: Via focus groups, we identified intrinsic and extrinsic factors relevant to acceptability of semisoft suppository prototypes. Willingness-to-try depended on factors like intended functionality, anticipated leakage, type of sex, recommended frequency of use, type of sexual partner, and perceived risk. When handled ex vivo, shape, size, and firmness of suppositories communicated information about ease of imagined insertion and handling, perceived effectiveness, anticipated awareness and comfort of the product in the body. These impressions were partly based on prior experience with vaginal products. CONCLUSIONS: Sensory attributes appear to play a substantial role in women's preferences and willingness to try the semisoft suppositories. Using these methods during preclinical development should help efficiently optimize a final product that is both biologically efficacious and preferred by women, toward a goal of enhancing adherence and effectiveness.

Histological and radiographic evaluation of polymethylmethacrylate with two different concentrations of barium sulfate in a sheep vertebroplasty model.

Percutaneous vertebral augmentation with PMMA has been widely performed and usually provides good pain relief and stabilization of fractured vertebrae. Adequate visualization of PMMA during injection is desirable to minimize cement extravasation, so contrast agents such as barium sulfate are commonly added to the PMMA. The aim of this study was to evaluate the differences of histology and radiographic visualization when different concentrations of barium sulfate are mixed with PMMA. Six sheep were utilized in this study. Three vertebrae of each animal were exposed via retroperitoneal approach, and a cavity was created and then filled with either 10% or 30% BaSO4/PMMA, or left empty. Vertebrae were harvested and analyzed radiographically and histologically 12 and 90 days after surgery. Average CT value of the 30% BaSO4/PMMA group was 2.4-fold higher than that of the 10% BaSO4/PMMA group. Foreign-body giant cells were recognized around BaSO4particles at 90 days in the 30% BaSO4 group, whereas few particles were recognized in the 10% group at 90 days, or in either group at 12 days. A very mild giant-cell reaction is induced by a higher concentration of BaSO4 in PMMA, but the marked improvement in cement visualization by increased BaSO4 may be important to minimize more serious complications of cement extravasation during PMMA injection.