This summer C-SOPS established a partnership with the U.S. Pharmacopoeial Convention (USP) to bring together experts in continuous pharmaceutical manufacturing to begin to address the development of standards within this space.
Our first joint activity was a roundtable workshop that took place at USP headquarters on June 27-28, 2016. The goal of this roundtable was to build consensus around the topic which would be best suited for consideration by USP committees tasked
The methodology enables real-time release testing. Tablets were made at a target drug concentration of 9% APAP, containing 90% lactose and 1% Magnesium Stearate, and at a target compression force of 24 kN. A model for predicting dissolution profiles was developed using a fractional factorial experimental design built around this targeted condition. This experimental design consisted of a 3^(4-1) fractional design resulting into a total of 27 testing conditions with additional