Development Process With the Aid of Automated Dissolution in Analytical Research and Development.

Abstract

The development of drugs in the generic pharmaceutical industry is a highly competitive arena of companies vying for the few drug products that are coming off patent. Companies that have been successful in this arena are those that have met or surpassed the critical timeline associated with trial formulation development, analytical method development and submission batch manufacturing and testing. Barr Laboratories has been successful in the Generic Pharmaceutical Industry for several reasons, one of which includes automation. The analytical research and development at Barr has employed the use of automated dissolution early in the lifecycle of a potential product. This approach has dramatically reduced the “Time To Market” on average for a number of products. The key to this approach is the network infrastructure of the formulation and analytical research and development departments. At Barr Laboratories Inc., our cooperative ability to work and communicate together has driven the departments to streamline and matrix their work efforts and optimize resources and time. The discussion will reference how Barr Laboratories Inc., has been successful with automation and give a case study of products that have moved with rapid pace through the development cycle.