Thermostable vaginal probiotic microbicide

耐热阴道益生菌杀菌剂

基本信息

批准号：
8649506
负责人：
Victor Bronshtein
金额：
$ 51.71万
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 2016-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8649506
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 public health relevance 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）：最近恢复的统计数据显示，全世界有3300万的hiver人数，撒哈拉以南非洲的68％Eing，当前的艾滋病毒预防方法，例如避孕套，一夫一妻制和戒酒对艾滋病毒的需求仍然是紧迫的，这些疾病是刺激性的疾病。在高环境温度下的阴道益生菌在高温下觅食，在温度下生存，快速散发膜制造（60»和Aboves）。提供常规的阴道菌皮。 M）含有PBV阴道益生菌的玻璃糖颗粒将被配制成Thinto Tolms，使用LMS提供了一个独特的递送平台。在益生菌菌心的潜在方法中，该膜在阴道膜中被认为是最可接受的。阴道和宫颈上皮。