Food and Drug Administration

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.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses

Contact

Eric Bozoian <br/>Grants Management Specialist <br/>Phone 2404027623
eric.bozoian@fda.hhs.gov