This presentation describes the dissolution method development for a parenteral injectable suspension that is administrated through intramuscular and intra-articular administration. A systematic method development employing quality-by-design (QbD) principle and science-based approach reveals that USP 4 is a suitable technique to measure the in vitro release of the injectable suspension and can be used as a quality control tool to ensure batch to batch consistency and product performance. The proposed USP apparatus 4 method is robust and can discriminate batches with out of specification particle sizes. The approaches of setting dissolution specification and the challenges and issues observed during technology transfer of the method will be shared and discussed.
Learning Objectives:
Upon completion, participants will be able to learn how to systematically develop a USP 4 dissolution method for injectable suspension.
Upon completion, participants will be able to understand the strategy of setting dissolution specification.
Upon completion, participants will be able to understand how to investigate and troubleshoot problems during technology transfer of such method.
