Use of Extrusion-Enabled Pharmaceutical Processes in Drug Development via a Streamlined Regulatory Pathway

Extrusion-enabled pharmaceutical processing (E2P2) has long been employed in pharmaceutical development (Drug Development and Industrial Pharmacy. 33:909-926,1043-1057 (2007)). Reasons for utilizing E2P2 include:

• Enhancing physico-chemical properties of APIs such as solubility and stability
• Modifying in vivo release of a drug to enhance bioavailability and clinical efficacy
• Facilitating development and manufacture of fixed combination drug products
• Improving manufacturing efficiency through continuous product manufacturing
• Increasing productivity by switching to continuous wet granulation processes
• Streamlining the control strategy for pharmaceutical processing
• Generating new intellectual property by creating novel forms of an API

E2P2 is, therefore, an ideal tool for life cycle management of new chemical entities and repurposing approved APIs and drug products. It is a significant platform for development of specialty pharmaceuticals. Furthermore, combining E2P2 with regulatory strategies focused on the 505(b)(2) pathway is an approach found to reduce the drug development data required for gaining marketing approval for a new drug product. Our team will explore examples of how E2P2 has been employed in conjunction with the 505(b)(2) approval pathway in an upcoming free half-day seminar — sign up for the seminar.

Posting prepared by Olu Aloba, M.S., Ph.D., Senior Director, Pharmaceutics