Utilizing Solid-State NMR Spectroscopy to Assess Properties of Lyophilized Formulations

Solid-state nuclear magnetic resonance (NMR) spectroscopy (SSNMR) is a powerful analytical technique that can be utilized to study lyophilized formulations. This chapter details basics of SSNMR spectroscopy and ways that SSNMR can be utilized to assess important properties of lyophilized formulations including excipient solid form, excipient and drug interactions in the solid state, changes in ionization of a formulation component, and mobility in the lyophilized solid. A case study is presented that utilizes SSNMR to look at the interaction of sucrose, trehalose, and mannitol with the model proteins lysozyme and bovine serum albumin.