Investigation of Peptide-Polymer Interaction in Poly(lactide-co-glycolide) Microspheres (U01)

Post Date

March 17th 2016

Application Due Date

May 20th 2016

Funding Opportunity Number

RFA-FD-16-012

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

1

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organization are not eligible to apply. Foreign components, are not allowed.

Funding

• Estimated Total Funding:

  $250000

• Award Range:

  $None - $250000

Grant Description

Although biodegradable poly(lactide-co-glycolide) (PLGA) polymers have been utilized extensively for the controlled release of peptide drugs, there is still a lack of in-depth understanding of peptide-polymer interaction in PLGA based microspheres. The purpose of the present study is to develop a systematic approach to assess the peptide-polymer interaction in PLGA based microsphere dosage forms. The developed approach should be able to identify the different types of peptide-polymer interactions, characterize and quantify related peptide degradation impurities (e.g., acylation peptide adducts), and determine the formulation parameters, hydration and degradation factors, and manufacturing processes responsible for facilitating peptide-polymer interaction. The results from this study will provide better understanding of peptide-polymer interaction in PLGA based drug delivery systems, which will help the Agency in developing recommendations for evaluation of generic microspheres containing peptide drugs.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Eric Bozoian
  Grants Management Specialist
  Phone 2404027623

• Agency Mailing Address:

  point of contact

• Agency Email Address:

  eric.bozoian@fda.hhs.gov

• More Information:

  Full Announcement of RFA-FD-16-012