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Firmness Perception Influences Women's Preferences for Vaginal Suppositories.

ABSTRACT: Microbicides are being actively researched and developed as woman-initiated means to prevent HIV transmission during unprotected coitus. Along with safety and efficacy, assessing and improving compliance is a major area of research in microbicide development. We have developed carrageenan-based semisoft vaginal suppositories and have previously evaluated how physical properties such as firmness, size and shape influence women's willingness to try them. Firmness has previously been quantified in terms of small-strain storage modulus, G', however large-strain properties of the gels may also play a role in the firmness perception. In the current study we prepared two sets of suppositories with the same G' but different elongation properties at four different G' values (250, 2500, 12,500, 25,000 Pa): For convenience we refer to these as "brittle" and "elastic", although these terms were never provided to study participants. In the first of two tests conducted to assess preference, women compared pairs of brittle and elastic suppositories and indicated their preference. We observed an interaction, as women preferred brittle suppositories at lower G' (250, 2500 Pa) and elastic ones at a higher G' (25,000 Pa). In the second test, women evaluated samples across different G', rated the ease-of-insertion and willingness-to-try and ranked the samples in order of preference. Brittle suppositories at G' of 12,500 Pa were most preferred. In vitro studies were also conducted to measure the softening of the suppositories in contact with vaginal simulant fluid (VSF). Release of antiretroviral drug tenofovir in VSF was quantified for the brittle and elastic suppositories at G' of 12,500 Pa to determine the effect of suppository type on release. The initial rate of release was 20% slower with elastic suppositories as compared to brittle suppositories. Understanding how different physical properties simultaneously affect women's preferences and pharmacological efficacy in terms of drug release is required for the optimization of highly acceptable and efficacious microbicides.

SUBMITTER: Zaveri T

PROVIDER: S-EPMC4190533 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Firmness Perception Influences Women's Preferences for Vaginal Suppositories.

Zaveri Toral T Primrose Rachel J RJ Surapaneni Lahari L Ziegler Gregory R GR Hayes John E JE

Pharmaceutics 20140910 3

Microbicides are being actively researched and developed as woman-initiated means to prevent HIV transmission during unprotected coitus. Along with safety and efficacy, assessing and improving compliance is a major area of research in microbicide development. We have developed carrageenan-based semisoft vaginal suppositories and have previously evaluated how physical properties such as firmness, size and shape influence women's willingness to try them. Firmness has previously been quantified in ...[more]

PMID: 25211123

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Project description:HIV and other sexually transmitted infections (STIs) are a global threat to public health that may be countered, in part, by microbicides. A successful microbicide must be both biologically efficacious and highly acceptable to users. Sensory attributes have a direct influence on product acceptability. We created a series of vaginal suppositories appropriate for use as microbicides to investigate the influence of shape on women's willingness-to-try. The influence of perceived size and firmness on acceptability was also assessed. Sexually-active women (n=99) were invited to participate in an evaluation of vaginal suppositories in 5 different shapes including: Bullet, Long Oval, Round Oval, Teardrop and Tampon. The volume (3mL) and formulation for these five prototypes were identical. After manipulating prototypes ex vivo (in their hands), participants rated their willingness-to-try on a 100-point visual analog scale. The appropriateness of size and firmness were evaluated using 5-point just-about-right (JAR) scales. Each participant evaluated all five prototypes individually. Samples were presented in a counterbalanced monadic sequence using a Williams design. Mean willingness-to-try varied by shape, with Bullet and Long Oval receiving significantly higher scores. This was consistent with JAR data for size, as 70% and 65% of women indicated these shapes were 'just-about-right', respectively. In contrast, a minority of women endorsed the other 3 shapes as having a size that was 'just-about-right'. The proportion of women who felt the firmness was 'just-about-right' was uniformly high, irrespective of shape, suggesting prior attempts to optimize the formula were successful. Perceptions of size and firmness were influenced by the physical length and width of the prototypes, in spite of having constant volume. Women showed high willingness-to-try when asked to assume they were at risk. These results are relevant for behavioral and formulation scientists working on microbicides, to better understand the influence of sensory attributes on acceptability, as acceptability and compliance ultimately impact effectiveness.

Project description:Problem: According to the guidelines, acute vulvovaginal candidosis (VVC) may be treated vaginally, through a combination of vaginal treatment and cream for the vulva or orally. However, there is a lack of investigations into whether combined treatment for the vagina and vulva achieves better results than vaginal treatment alone. Method: In 1999, 160 patients with vulvovaginal candidosis from ten German gynaecological practices were included in a study and treated on a randomised basis with three 200 mg clotrimazol vaginal suppositories = clotrimazol 2 % cream (verum n = 79) or + placebo (active-ingredient-free cream base n = 79). The examinations took place before treatment (T1), six to eight days following the end of treatment (T2) and approximately four weeks following the end of treatment (T3). In addition to demographic data, the clinical findings of each investigation were documented in a standardised way and a native preparation and a fungal culture were taken. The doctor and patient evaluated the healing process and tolerance. The main efficacy variables were the pre/post difference scores for extravaginal redness. Results: On T1, there was no difference between the two groups. By T2, there was a significant difference in the extent of extravaginal redness between the verum and the placebo groups (p = 0.0002), as well as in the subgroup of the per-protocol analysis (verum 64, placebo 70 patients, p = 0.0015). Genital itching or burning had entirely disappeared in 51 % and 56 % of patients respectively in the verum group and in only 30 % and 45 % of patients in the placebo group on T2 (p = 0.0181). There was no difference in intravaginal redness on T1 and T2 in either group. The overall assessment by the doctor went accordingly (p = 0.0004). On T1, the extravaginal fungal culture was positive in 75 women in the verum group and in 76 women in the placebo group. On T2, however, this was positive in 51.9 % (verum) and 73.1 % (placebo) of cases, and a positive culture was evinced in the vagina in 6 vs. 8 women (7.5 vs. 10.1 %, p = 0.3802). The local tolerance in both groups was 70 % very good, and 29 vs. 27 % good. After four weeks (T3), 16 out of 23 patients in the verum group and only 8 out of 21 in the placebo group had negative extravaginal fungal cultures. Discussion: There is a lack of studies into the issue of whether vaginal treatment or combined vulvovaginal treatment of acute VVC would be more advantageous. However, there are two studies that support the significant results of this paper that when it comes to acute VVC, the combination of three 200 mg clotrimazol vaginal suppositories with clotrimazol cream 2 % is better than with vaginal suppositories alone.

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Firmness Perception Influences Women's Preferences for Vaginal Suppositories.

Publications

Firmness Perception Influences Women's Preferences for Vaginal Suppositories.

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