Characterization of Critical Quality Attributes for Semisolid Topical Drug Products

Information

  • Research Project
  • 8924792
  • ApplicationId
    8924792
  • Core Project Number
    U01FD005226
  • Full Project Number
    5U01FD005226-02
  • Serial Number
    005226
  • FOA Number
    RFA-FD-14-010
  • Sub Project Id
  • Project Start Date
    9/10/2014 - 10 years ago
  • Project End Date
    8/31/2019 - 5 years ago
  • Program Officer Name
  • Budget Start Date
    9/1/2015 - 9 years ago
  • Budget End Date
    8/31/2016 - 8 years ago
  • Fiscal Year
    2015
  • Support Year
    02
  • Suffix
  • Award Notice Date
    8/24/2015 - 9 years ago

Characterization of Critical Quality Attributes for Semisolid Topical Drug Products

Abstract There is an urgent need to establish Quality target product profile (QTPP) for topical products and identify the Critical Quality Attributes (CQAs) to develop meaningful drug product specifications based on clinical performance and to ensure equivalent safety and efficacy to the Reference Listed Drug (RLD). Most semisolid preparations such as pharmaceutical/ cosmetic creams, ointments, lotions etc. display complex flow behaviour including breakdown on application of high shear, thixotropy and viscoelasticity which can be described by the methods used in measurement of these parameters. Most of the semisolid systems such as ointments, creams, pastes, and gels are viscoelastic in nature as they display both liquid and solid properties within the same material. In this project we aim to vary key formulation and manufacturing parameters to identify and define potential failure mode that effect a products performance. We will compare bioavailability using both finite (in use) and infinite dosing and use tools such as Atomic Force Microscopy (AFM), Confocal Raman and multiphoton microscopy to study the effects of excipients and formulation on in vitro and in vivo skin. Apart from BE we aim to define cosmetic equivalence (CE). Sensorial similarity/cosmetic equivalence will be defined as a critical quality attribute through this process.

IC Name
FOOD AND DRUG ADMINISTRATION
  • Activity
    U01
  • Administering IC
    FD
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    249750
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
  • Ed Inst. Type
  • Funding ICs
    FDA:249750\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    ZFD1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    UNIVERSITY OF SOUTH AUSTRALIA
  • Organization Department
  • Organization DUNS
    756220208
  • Organization City
    ADELAIDE
  • Organization State
  • Organization Country
    AUSTRALIA
  • Organization Zip Code
    5095
  • Organization District
    AUSTRALIA