Evaluation of in vitro release methods for liposomal drug products

This study is intended to advance the regulatory review process of generic liposomal drug products, which in turn will help provide the US public with access to high quality generic liposomal drug products. Detailed description: Using amphotericin B, daunorubicin citrate, or vincristine sulfate liposomal injection as a model drug product, the project will involve the following: a. Review available in vitro release methods for the selected model liposomal drug product(s). b. Prepare a series of liposome formulations with similar formulation composition to the marketed model product but with different process conditions. Characterize physicochemical properties including mean particle size and distribution, surface charge, pH, shape, lamellarity and others. c. Conduct dissolution studies of prepared liposome formulations (including the marketed model product) with various in vitro release methods. Both conventional methods and innovative in vitro release study design can be explored. d. Vary in vitro release conditions and identify critical factors that affect the performance of each type of in vitro release method evaluated. e. Identify in vitro release methods which can distinguish liposome formulations with different in vitro characteristics. Use the in vitro release data together with animal data or human data to establish an in silico platform and explore in vitro in vivo correlation of selected liposomal drug product(s).
Source: Grants.gov - Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding