title: Fused deposition modeling provides solution for magnetic resonance imaging of solid dosage form by advancing design quickly from prototype to final product.
abstract: The release profile of active pharmaceutical ingredient (API) from its solid dosage form is an important aspect of drug development as it is often used to predict potential drug release characteristics of a product in vivo. In recent years, magnetic resonance imaging has emerged as a nondestructive technique that captures the physical changes of solid dosage forms during dissolution. An example that highlights this application is in the dissolution of modified-release tablet studies. As the tablet dissolves, API disperses in a hydrogel matrix within the tablet, and swelling of the hydrogel layer eventually leads to release of API over time. To achieve optimum signal-to-noise ratios, the tablet should be placed in the most homogeneous region of the magnet and remain there throughout the dissolution experiment. Moreover, the tablet holder must maintain the tablet position without interfering with the natural dissolution process, such as by crushing the softened tablet. This can be difficult because the size, shape, and rigidity of the tablet change during dissolution. This article describes the process, material, and manufacture of a novel device that meets these challenges, with emphasis on how additive manufacturing on a 3D printer enabled an efficient and inexpensive process of design improvements.
authors.affiliation: Amgen Inc., Cambridge, Massachusetts, USA. kcharest@amgen.com
authors.forename: Ken
authors.initials: K
authors.lastname: Charest
authors.forename: Melody L
authors.initials: ML
authors.lastname: Mak-Jurkauskas
authors.forename: Daniel
authors.initials: D
authors.lastname: Cinicola
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Clausen
mesh_terms: D004304:Dosage Forms; D004867:Equipment Design; D008279:Magnetic Resonance Imaging / Q000295:instrumentation* / Q000379:methods*; D008962:Models, Theoretical; D012815:Signal Processing, Computer-Assisted; D013607:Tablets; D013997:Time Factors
chemical_list: D004304:Dosage Forms; D013607:Tablets