Expediting the formulation development process with the aid of automated dissolution in analytical research and development

[摘要] The development of drugs in the generic pharmaceutical industry is a highly competitive arena of companies vying for 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 Inc., 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, the 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 has been successful with automation and gives a case study of products that have moved with rapid pace through the development cycle

[学科分类] 分析化学