Firmness Perception Influences Women's Preferences for Vaginal Suppositories.
Firmness Perception Influences Women's Preferences for Vaginal Suppositories.
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DOI：
10.3390/pharmaceutics6030512
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发表时间：
2014-09-10
期刊：
影响因子：
5.4
通讯作者：
Hayes JE
中科院分区：
文献类型：
--
作者：
Zaveri T;Primrose RJ;Surapaneni L;Ziegler GR;Hayes JE
目前正在积极研究和开发杀微生物剂，将其作为妇女发起的手段，以防止在无保护措施的性行为中传播艾滋病毒。除安全性和有效性外，评估和改进依从性是杀微生物剂开发的一个主要研究领域。我们已经开发了基于卡拉胶的半同功阴道栓剂，并先前评估了坚固性、大小和形状等物理特性如何影响女性尝试它们的意愿。坚固性以前是用小应变储存模数G‘来量化的，然而凝胶的大应变性质也可能在坚固性感知中起作用。在目前的研究中，我们制备了两套栓剂，在四个不同的G‘值(250,2500，12,500，25,000帕)下具有相同的G’但不同的伸长率：为方便起见，我们将这些术语称为“脆性”和“弹性”，尽管这些术语从未提供给研究参与者。在评估偏好的两个测试中的第一个中，女性比较了成对的脆性和弹性栓剂，并指出了她们的偏好。我们观察到一种相互作用，女性在较低G‘(250,2500帕)时更喜欢脆性栓剂，而在较高G’(25,000帕)时更喜欢弹性栓剂。在第二个测试中，女性评估了不同G‘的样本，对插入的易用性和尝试的意愿进行了评级，并按偏好顺序对样本进行了排名。在G‘为12,500Pa时，以脆性栓剂最好。还进行了体外研究，以测量栓剂与阴道模拟液(VSF)接触时的软化程度。测定脆性栓剂和弹性栓剂在12,500PaVSF中的释放量，以确定栓剂类型对释药的影响。与脆性栓剂相比，弹性栓剂的初始释放速度慢20%。了解不同的物理性质如何同时影响妇女在药物释放方面的喜好和药效，是优化高度可接受和有效的杀微生物剂所必需的。
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.