June 17, 2014
Outsourcing the development and manufacturing of generic drug products is a very common strategy in today’s current global market. Because of this, some of the biggest generic manufacturers of orally inhaled and nasal drug products (OINDPs) are located overseas. As a result, evaluating out-of-specification issues, establishing batch-to-batch equivalency, addressing the stability of the products during scale-up, long-term storage, and shipping in varying environmental conditions has become of paramount importance for the industry and regulating agencies around the world.
For assessing product quality, establishing bioavailability, and proofing bioequivalence of generic OINDPs, the US FDA requires that the extent and size of drug particle agglomerates is determined, as well as the size and number of primary active pharmaceutical ingredients (API) particles. Gateway Analytical offers expert analytical solutions to help generic manufacturers obtain this information, and, as a result, helps them get their products to market faster. Among numerous analytical offerings for the analysis of pharmaceuticals, Gateway Analytical utilizes Raman Chemical Imaging (RCI)  for chemically specific analysis that can identify whether a product contains a significant amount of aggregates/agglomerates and whether observed agglomerates are combinations of multiple primary API particles, API-excipient particles, or multiple excipient particles.