25. July 2018
Concentrated monoclonal antibody (mAb) solutions can lead to high viscosity as a result of protein-protein interactions and pose challenges for manufacture. Dipicolinic acid (DPA, pyridine-2,6-dicarboxylic acid) is a potential excipient for reduction of protein solution viscosity and here we describe new DPA salts with improved aqueous solubility. Crystallinity and solubility screens identified ethanolamine and diethanolamine as two promising counterions which generated crystalline, high...
27. May 2018
A systematic assessment of key material attributes of active pharmaceutical ingredients (APIs) using minimal material approach is illustrated at the particulate level and bulk level. At a bulk level, flowability improvement of an API through crystal habit manipulation is exemplified. The impact of crystal structures and particulate properties (crystal habit and crystal size) on their mechanical behaviour were addressed by measuring powder tabletability. Bulk powder flow and tabletability were...
07. February 2016
In the pharmaceutical industry, dextrose is used as an active ingredient in parenteral solutions and as an inactive ingredient (excipient) in tablets and capsules. In order to address the need for more sophisticated analytical techniques, we report our efforts to develop enhanced identification methods to screen pharmaceutical ingredients at risk for adulteration or substitution using field-deployable spectroscopic screening. In this paper we report our results for a study designed to evaluate...