CORE--FORMULATIONS

核心--配方

基本信息

项目摘要

The overall goal of the Formulations Core is to provide preformulation and formulation development support for Projects 1,2, 3, and 4 of this grant application. Specifically the Formulations Core will 1) Support Project 1 by assisting in the optimization of the lyophilization of LAB secreting CVN 2) Provide preformulation chemical and physical evaluations of retrocyclin microbicide agents and subsequent analogs developed in Project 2, 3) Develop, optimize, and assess formulated vaginal products for LAB secreting CVN developed in Project 1 and Retrocyclin analogs developed in Project 2 4) Conduct stability evaluations for potential microbicide candidate formulations. 5) Coordinate the synthesis and distribution of peptide for use in Projects 1, 2, 3, and 4. 6) Provide Project 3 with formulated products for evaluation in the explant model, 7) Assist with optimization of the explant model being evaluated in Project 3 for use with viscous products, and 8) Provide sufficient quantity of formulated test microbicide products for animal safety testing in Project 4. Quantitative methods will be developed for each lead retrocyclin analog identified in Project 2. Preformulation assessment of microbicide candidates will consist of physical and chemical characterization of the drug in both the solid and solution state. Additionally, potential modes of degradation will be evaluated for each candidate in this core and acute toxicity evaluated in vitro in collaboration with Project 3. These data will be utilized to develop safe, effective, and stable vaginal formulations which can then be evaluated in preclinical animal testing in Project 4. Formulated microbicidal candidates will be assessed for stability, rate of drug release, acute toxicity (in collaboration with Project 3) and anti-STI activity (in collaboration with Projects 2 and 3). The Formulation Core will also be responsible for coordination of retrocyclin synthesis and distribution. Upon receipt of synthesized analogs, quality control evaluations and quantitation will be conducted by the core prior to distribution of the peptide to the projects. This Core will directly support Projects 1,2,3, and 4.
配方核心的总体目标是为本赠款申请的项目1、2、3和4提供配方前和配方开发支持。具体而言,制剂核心将1)通过协助优化分泌CVN的LAB的冻干来支持项目1,2)提供项目2中开发的逆转录细胞周期素杀微生物剂和后续类似物的制剂前化学和物理评价,3)开发、优化、并评估在项目1中开发的分泌CVN的LAB和在项目2中开发的Retrocyclin类似物的配制阴道产品进行潜在稳定性评估 杀微生物剂候选制剂。5)协调用于项目1、2、3和4的肽的合成和分配。6)为项目3提供用于外植体模型评价的配制产品,7)协助优化项目3中评价的外植体模型,以用于粘性产品,8)为项目4中的动物安全性试验提供足量的配制试验杀微生物剂产品。将为项目2中确定的每种主要逆转录细胞周期蛋白类似物开发定量方法。候选杀微生物剂的配方前评估将包括固体和溶液状态下药物的物理和化学特性。此外,将评价该核心中每种候选物的潜在降解模式,并与项目3合作进行体外急性毒性评价。这些 数据将用于开发安全、有效和稳定的阴道制剂,然后可以在项目4的临床前动物试验中对其进行评价。将评估配制的杀微生物剂候选物的稳定性、药物释放率、急性毒性(与项目3合作)和抗性传播感染活性(与项目2和3合作)。制剂中心还将负责协调retrocyclin的合成和分布。收到合成类似物后,在将肽分配给项目之前,将由核心进行质量控制评价和定量。该核心将直接支持项目1、2、3和4。

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Lisa Cencia Rohan其他文献

Engineering vaginal film platform for mucoadhesion and sustained drug release for HIV-1 prevention
用于预防 HIV-1 的黏膜黏附和持续药物释放的工程化阴道薄膜平台
  • DOI:
    10.1016/j.jconrel.2025.01.011
  • 发表时间:
    2025-03-10
  • 期刊:
  • 影响因子:
    11.500
  • 作者:
    Jing Li;Sravan Kumar Patel;Yvonne Sweeney;Dorothy Patton;Peter Anderson;Sharon L. Hillier;Lisa Cencia Rohan
  • 通讯作者:
    Lisa Cencia Rohan
Preparations de liposomes et procede d'utilisation
脂质体的制备及其应用程序
  • DOI:
  • 发表时间:
    2004
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Hans Hofland;Lisa Cencia Rohan
  • 通讯作者:
    Lisa Cencia Rohan
Vaginal Drug Delivery Systems for HIV Prevention
  • DOI:
    10.1208/s12248-009-9082-7
  • 发表时间:
    2009-02-05
  • 期刊:
  • 影响因子:
    3.700
  • 作者:
    Lisa Cencia Rohan;Alexandra B. Sassi
  • 通讯作者:
    Alexandra B. Sassi

Lisa Cencia Rohan的其他文献

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{{ truncateString('Lisa Cencia Rohan', 18)}}的其他基金

Long Acting Film Technology for Contraception and HIV Prevention (LATCH)
用于避孕和艾滋病毒预防的长效薄膜技术 (LATCH)
  • 批准号:
    10545302
  • 财政年份:
    2019
  • 资助金额:
    $ 19.85万
  • 项目类别:
Long Acting Film Technology for Contraception and HIV Prevention (LATCH)
用于避孕和艾滋病毒预防的长效薄膜技术 (LATCH)
  • 批准号:
    10580096
  • 财政年份:
    2019
  • 资助金额:
    $ 19.85万
  • 项目类别:
A Biorelevant Dissolution Methods for Particulate Dosage Forms in the Periodontal Pocket
牙周袋中颗粒剂型的生物相关溶出方法
  • 批准号:
    9060017
  • 财政年份:
    2015
  • 资助金额:
    $ 19.85万
  • 项目类别:
A Biorelevant Dissolution Methods for Particulate Dosage Forms in the Periodontal Pocket
牙周袋中颗粒剂型的生物相关溶出方法
  • 批准号:
    9352618
  • 财政年份:
    2015
  • 资助金额:
    $ 19.85万
  • 项目类别:
Dosage Form Design Strategies for Delivery of UC781 and Tenofovir
UC781 和替诺福韦的剂型设计策略
  • 批准号:
    8471639
  • 财政年份:
    2013
  • 资助金额:
    $ 19.85万
  • 项目类别:
Dosage Form Design Strategies for Delivery of UC781 and Tenofovir
UC781 和替诺福韦的剂型设计策略
  • 批准号:
    7898231
  • 财政年份:
    2010
  • 资助金额:
    $ 19.85万
  • 项目类别:
Formulation Development Core
配方开发核心
  • 批准号:
    7681954
  • 财政年份:
    2009
  • 资助金额:
    $ 19.85万
  • 项目类别:
Formulation Core
配方核心
  • 批准号:
    7681873
  • 财政年份:
    2009
  • 资助金额:
    $ 19.85万
  • 项目类别:
Formulations
配方
  • 批准号:
    7979344
  • 财政年份:
    2009
  • 资助金额:
    $ 19.85万
  • 项目类别:
TRANSPORT AND ACTIVITY OF MICROBICIDES FORMULATIONS
杀菌剂制剂的运输和活性
  • 批准号:
    6662087
  • 财政年份:
    2002
  • 资助金额:
    $ 19.85万
  • 项目类别:

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