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

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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.