title: Optical coherence tomography-based freeze-drying microscopy.
abstract: A new type of freeze-drying microscope based upon time-domain optical coherence tomography is presented here (OCT-FDM). The microscope allows for real-time, in situ 3D imaging of pharmaceutical formulations in vials relevant for manufacturing processes with a lateral resolution of <7 μm and an axial resolution of <5 μm. Correlation of volumetric structural imaging with product temperature measured during the freeze-drying cycle allowed investigation of structural changes in the product and determination of the temperature at which the freeze-dried cake collapses. This critical temperature is the most important parameter in designing freeze-drying processes of pharmaceutical products.
authors.affiliation: Physical Sciences, Inc., 20 New England Business Center, Andover, MA 01810, USA. mujat@psicorp.com
authors.forename: Mircea
authors.initials: M
authors.lastname: Mujat
authors.forename: Kristyn
authors.initials: K
authors.lastname: Greco
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Galbally-Kinney
authors.forename: Daniel X
authors.initials: DX
authors.lastname: Hammer
authors.forename: R Daniel
authors.initials: RD
authors.lastname: Ferguson
authors.forename: Nicusor
authors.initials: N
authors.lastname: Iftimia
authors.forename: Phillip
authors.initials: P
authors.lastname: Mulhall
authors.forename: Puneet
authors.initials: P
authors.lastname: Sharma
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Pikal
authors.forename: William J
authors.initials: WJ
authors.lastname: Kessler