Forumlation Development and Selection of DuoGels and Smart Suppositories

Information

  • Research Project
  • 8862359
  • ApplicationId
    8862359
  • Core Project Number
    U19AI101961
  • Full Project Number
    5U19AI101961-04
  • Serial Number
    101961
  • FOA Number
    RFA-AI-11-031
  • Sub Project Id
    7979
  • Project Start Date
    -
  • Project End Date
    5/31/2016 - 8 years ago
  • Program Officer Name
  • Budget Start Date
    6/1/2015 - 9 years ago
  • Budget End Date
    5/31/2016 - 8 years ago
  • Fiscal Year
    2015
  • Support Year
    04
  • Suffix
  • Award Notice Date
    4/29/2015 - 9 years ago

Forumlation Development and Selection of DuoGels and Smart Suppositories

PROJECT SUMMARY (See instructions): As the practice of receptive anal intercourse is not limited to men who have sex with men (MSM), and there is clear evidence of both receptive vaginal and anal intercourse in the same sexual act, there is a strong rationale for the development of a microbicide formulation that is suitable for both rectal and vaginal application. A dual compartment microbicide formulation will reduce the complexity of maintaining separate dosage forms for women who engage in both anal and vaginal sex. With the promising development of the IQP-0528/TFV combination vaginal gel, a novel dual vaginal and rectal gel (DuoGel) will be developed in Project 1 from the preexisting gel formulation. In addition, to directly address potential issues of user acceptability and physiological differences between the vagina and rectum in a dual chamber microbicide product, a smart suppository device will be developed that will respond to environmental changes to beideal for either vaginal or rectal delivery. The DuoGel development will comprise the formulation of a singleIQP-0528 product and the combination IQP-0528/TFV product through rheological, anti-viral, in-vitro, and exvivo toxicity and safety evaluations based on selection criteria defined by Core B (gel PK and gel spreading). Core C (microbicide efficacy and dosing), and Project 2 (API concentration from MTSA). The smart suppository will be developed to respond to the changing pH differences in the vagina and rectum through pH sensitive nanoparticles that will release pH maintaining salts to prompt ideal environment for drug delivery. Iterative evaluations between Project 1, Core B and Core C will identify a gel and suppository formulation to be moved forward in animal trials (Project 3).

IC Name
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
  • Activity
    U19
  • Administering IC
    AI
  • Application Type
    5
  • Direct Cost Amount
    218807
  • Indirect Cost Amount
    34562
  • Total Cost
  • Sub Project Total Cost
    253369
  • ARRA Funded
    False
  • CFDA Code
  • Ed Inst. Type
  • Funding ICs
    NIAID:253369\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    ZAI1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    IMQUEST BIOSCIENCES
  • Organization Department
  • Organization DUNS
    146051664
  • Organization City
    FREDERICK
  • Organization State
    MD
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    217049405
  • Organization District
    UNITED STATES