Formulation and Quality
2019 PharmSci 360
Pharmaceutical formulation today is facing multiple challenges triggered by fast evolving requirements in drug development. On the formulation side, these range from ensuring bioavailability of poorly water-soluble APIs to designing innovative delivery systems and targeted drug release profiles. On the manufacturing side, these range from gaining speed in process scale-up and cost efficiency in manufacturing to providing more and more personalized solutions for patients. In this session, we will illustrate and discuss several approaches to address many these challenges from various perspectives, specifically, existing and novel multifunctional excipients coupled with modern analytical methods, innovative manufacturing systems, cutting-edge formulation technologies and digital prediction of optimal drug-excipient combinations. Contributions from both Industry and Academia will be structured in 6 targeted presentations followed by Q&A sessions.
Part 1 - Materials to support faster process and PAT model development for continuous manufacturing applications
Formulations amenable for continuous direct compression must be optimized in terms of flowability, shear-sensitivity and compressibility to ensure robust process performance and drug product quality. Historically, this has been achieved by including a glidant, filler, dry binder, disintegrant and lubricant into a “simple” formulation. However, as the number of excipients increase so does the complexity of the control architecture, and the efforts required to develop a near infrared (NIR) spectroscopic method for process monitoring. This presentation will describe a faster approach to develop an NIR method for monitoring drug concentration at the feed frame, and the role of material properties in predicting process performance.
Presenters: Krizia M. Karry, BASF and Rodolfo J. Romanach, Univ. of Puerto Rico
Time Title and Presenters
9:00AM Introduction and Moderator: Andrea Vescovi, BASF
9:00AM - 10:00AM Materials to Support Faster Process and PAT Model Development for Continuous Manufacturing Applications. Presenters: Krizia Karry, BASF and Rodolfo J. Romanach, Univ. of Puerto Rico
10:00AM - 10:30AM Innovations in the Formulation and Processing of Poorly Water Soluble Drugs. Presenter: Dr. Frank Romanski, BASF
10:30AM - 11:00AM 3D printing. Details to follow
11:00AM - 11:30AM Innovation in Excipients. Presenter: Dr. Karl Kolter, BASF
11:30AM - 12:00PM Digital Assistant to Support Product Development. Presenter: Dr. Ferdinand Brandl, BASF