Science & Research

Influence of Raw Materials, Manufacturing Variables, and Storage Conditions on Release Performance of Long-Acting Release Microsphere Products

Performer: College of Pharmacy, University of Michigan

Principal Investigator: Steven Schwendenman

Project Duration: 9/30/2015-9/30/2018

Regulatory Science Challenge

There is a current gap between our scientific understanding of what happens when long-acting release drug formulations (LARs) are manufactured and stored, and how they perform when administered to patients. This knowledge gap impacts research and development of generic LARs by drug companies and creates uncertainties for FDA when evaluating regulatory submissions. As there in an increased number of anticipated generic LAR submissions to the FDA, there is need to address this knowledge gap.

Project Description & Goals

There are several variables in the manufacturing process that can affect the final drug product and its performance upon administration including the materials and methods used in manufacturing, specific manufacturing parameters, and storage conditions. These variables will be characterized and tested to determine the optimal conditions for development and storage of LARs. The overall goal is to develop an approach that can be extended to various types of LARs.

Page Last Updated: 09/11/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English