Thermostable vaginal probiotic microbicide

耐热阴道益生菌杀菌剂

基本信息

批准号：
8852528
负责人：
Victor Bronshtein
金额：
$ 52.58万
依托单位：
UNIVERSAL STABILIZATION TECHNOLOGIES
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-05-01 至 2017-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8852528
关键词：
AIDS prevention Abstinence Accounting Acids Adolescence Adult Africa South of the Sahara Age-Years Anaerobic Bacteria Anti-Infective Agents Anti-Inflammatory Agents Anti-inflammatory Antiviral Agents Bacteria Bacterial Vaginosis Biological Biological Preservation Cell Culture Techniques Cells Cervical Clinical Research Coitus Cold Chains Contracts Development Dosage Forms Drug Formulations Environment Epidemic Epithelium Female Feminization Film Freeze Drying Goals HIV Individual Infection Intestines Intravaginal Administration Lactobacillus Legal patent Life Local Microbicides Mechanics Methods Modeling National Institute of Allergy and Infectious Disease Phase Polymers Powder dose form Preparation Prevention Prevention strategy Primates Probability Probiotics Procedures Production Property Recovery Research Infrastructure Risk Sexually Transmitted Diseases Suppositories System Tablets Techniques Technology Temperature Therapeutic Time Universities Vagina Washington Water Woman aged base cold temperature condoms girls improved innovation man microbicide particle preference prototype safety testing statistics sugar transmission process user-friendly vaginal microbicide vaporization

项目摘要

DESCRIPTION (provided by applicant): Recently revised statistics show the number of individuals living with HIV at over 33 million worldwide, with 68% being in sub-Saharan Africa. Current HIV prevention methods, such as condom use, monogamy and abstinence, are not always feasible. The need for improved HIV preventative technologies remains urgent. The development of topical microbicides represents a new and exciting field in the prevention of sexually transmitted diseases. Of these, application of live probiotic bacterial microbicides (PBM) represents a promising preventative method. Our ultimate goal is to develop potent optimized multistrain thermostable and easily deliverable probiotic vaginal topical microbicides. To achieve this goal we will stabilize vaginal probiotics for long-term storage at high ambient temperatures and short term survival at temperatures required for quick dissolve film manufacturing (60�C and above). The cornerstones of this proposal are: 1) Preservation by Vaporization" (PBV) - an innovative, patent pending method of dry-stabilizing probiotics bacteria and other fragile biologicals at high ambient temperatures, and 2) Quick-dissolve thin film technology that is being optimized to deliver conventional vaginal microbicides. The strategy can be described briefly as, to occupy the vaginal epithelium and provide a long lasting protective environment against HIV, BV, and STI acquisition small (10-50 �m) glassy sugar particles containing PBV vaginal probiotic bacteria will be formulated into thin films which utilize a water soluble polymer base. Thin films offer a unique delivery platform which has a number of advantages over other dosage forms. In a recent study comparing women's preference between films, tablets and ovules, the film dosage form was shown to have greatest acceptability among women studied. We believe that women will prefer using a vaginal film over other potential methods of probiotic microbicide delivery especially if a long-acting effect of the bacteria colonizing vaginal epithelium allows for less frequent use. Biologic properties of PBM after long-term storage at ambient temperatures will be characterized using cell culture models of vaginal and cervical epithelium.

描述（由申请人提供）：修订后的最新统计数据显示，全球艾滋病毒感染者人数超过 3300 万，其中 68% 生活在撒哈拉以南非洲地区。目前的艾滋病毒预防方法，如使用安全套、一夫一妻制和禁欲，并未得到落实。改进艾滋病毒预防技术的需求仍然迫切，局部杀微生物剂的开发代表了预防性传播疾病的一个令人兴奋的新领域，其中活益生菌杀微生物剂的应用。 (PBM) 代表了一种有前途的预防方法。我们的最终目标是开发有效的优化多菌株耐热且易于递送的益生菌阴道局部杀菌剂，以实现这一目标，我们将稳定阴道益生菌，以便在高环境温度下长期储存和短期生存。快速溶解薄膜制造所需的温度（60°C 及以上）该提案的基石是：1) 蒸发保存”(PBV) - 一种创新的、正在申请专利的干稳定方法。益生菌细菌和其他脆弱的生物制品在高环境温度下，以及2）快速溶解薄膜技术，正在优化以提供传统的阴道杀菌剂该策略可以简单地描述为，占据阴道上皮并提供持久的保护环境。针对 HIV、BV 和 STI 采集，含有 PBV 阴道益生菌的小玻璃状糖颗粒（10-50 µm）将被配制成薄膜，该薄膜利用水溶性聚合物基质提供独特的递送平台。与其他剂型相比，在最近一项比较女性对膜剂、片剂和胚珠的偏好的研究中，显示膜剂型在所研究的女性中具有最高的可接受性，我们相信，与其他潜在剂型相比，女性更喜欢使用阴道膜剂。益生菌杀微生物剂的递送方法，特别是如果定植于阴道上皮的细菌的长效作用允许在环境温度下长期储存后较少使用 PBM 的生物学特性，则将使用阴道和宫颈细胞培养模型来表征。上皮。